Interventions for preventing obesity in children

  • Review
  • Intervention

Authors

  • Elizabeth Waters,

    Corresponding author
    1. The University of Melbourne, Jack Brockhoff Child Health and Wellbeing Program, The McCaughey Centre, Melbourne School of Population and Global Health, Carlton, VIC, Australia
    • Elizabeth Waters, Jack Brockhoff Child Health and Wellbeing Program, The McCaughey Centre, Melbourne School of Population and Global Health, The University of Melbourne, Level 5/207 Bouverie St, Carlton, VIC, 3010, Australia. ewaters@unimelb.edu.au.

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  • Andrea de Silva-Sanigorski,

    1. The University of Melbourne, Jack Brockhoff Child Health and Wellbeing Program, The McCaughey Centre, Melbourne School of Population and Global Health, Parkville, Victoria, Australia
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  • Belinda J Burford,

    1. The University of Melbourne, The Jack Brockhoff Child Health and Wellbeing Program, The McCaughey Centre, Melbourne School of Population and Global Health, Parkville, VIC, Australia
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  • Tamara Brown,

    1. Division of Clinical Effectiveness, School of Population, Community and Behavioural Sciences, University of Liverpool, Liverpool Reviews and Implementation Group, Liverpool, UK
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  • Karen J Campbell,

    1. School of Exercise and Nutrition Sciences, Deakin University, Centre for Physical Activity and Nutrition Research, Burwood, VIC, Australia
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  • Yang Gao,

    1. The Chinese University of Hong Kong, School of Public Health and Primary Care, Hong Kong, Hong Kong
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  • Rebecca Armstrong,

    1. The University of Melbourne, Jack Brockhoff Child Health and Wellbeing Program, The McCaughey Centre, Melbourne School of Population and Global Health, Parkville, Victoria, Australia
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  • Lauren Prosser,

    1. Dental Health Services Victoria, Carlton, Victoria, Australia
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  • Carolyn D Summerbell

    1. Queen's Campus, Durham University, School of Medicine and Health, Wolfson Research Institute, Stockton-on-Tees, UK
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Abstract

Background

Prevention of childhood obesity is an international public health priority given the significant impact of obesity on acute and chronic diseases, general health, development and well-being. The international evidence base for strategies that governments, communities and families can implement to prevent obesity, and promote health, has been accumulating but remains unclear.

Objectives

This review primarily aims to update the previous Cochrane review of childhood obesity prevention research and determine the effectiveness of evaluated interventions intended to prevent obesity in children, assessed by change in Body Mass Index (BMI). Secondary aims were to examine the characteristics of the programs and strategies to answer the questions "What works for whom, why and for what cost?"

Search methods

The searches were re-run in CENTRAL, MEDLINE, EMBASE, PsychINFO and CINAHL in March 2010 and searched relevant websites. Non-English language papers were included and experts were contacted.

Selection criteria

The review includes data from childhood obesity prevention studies that used a controlled study design (with or without randomisation). Studies were included if they evaluated interventions, policies or programs in place for twelve weeks or more. If studies were randomised at a cluster level, 6 clusters were required.

Data collection and analysis

Two review authors independently extracted data and assessed the risk of bias of included studies.  Data was extracted on intervention implementation, cost, equity and outcomes. Outcome measures were grouped according to whether they measured adiposity, physical activity (PA)-related behaviours or diet-related behaviours.  Adverse outcomes were recorded. A meta-analysis was conducted using available BMI or standardised BMI (zBMI) score data with subgroup analysis by age group (0-5, 6-12, 13-18 years, corresponding to stages of developmental and childhood settings).

Main results

This review includes 55 studies (an additional 36 studies found for this update). The majority of studies targeted children aged 6-12 years.  The meta-analysis included 37 studies of 27,946 children and demonstrated that programmes were effective at reducing adiposity, although not all individual interventions were effective, and there was a high level of observed heterogeneity (I2=82%). Overall, children in the intervention group had a standardised mean difference in adiposity (measured as BMI or zBMI) of -0.15kg/m2 (95% confidence interval (CI): -0.21 to -0.09). Intervention effects by age subgroups were -0.26kg/m2 (95% CI:-0.53 to 0.00) (0-5 years), -0.15kg/m2 (95% CI -0.23 to -0.08) (6-12 years), and -0.09kg/m2 (95% CI -0.20 to 0.03) (13-18 years). Heterogeneity was apparent in all three age groups and could not explained by randomisation status or the type, duration or setting of the intervention.  Only eight studies reported on adverse effects and no evidence of adverse outcomes such as unhealthy dieting practices, increased prevalence of underweight or body image sensitivities was found.  Interventions did not appear to increase health inequalities although this was examined in fewer studies.

Authors' conclusions

We found strong evidence to support beneficial effects of child obesity prevention programmes on BMI, particularly for programmes targeted to children aged six to 12 years. However, given the unexplained heterogeneity and the likelihood of small study bias, these findings must be interpreted cautiously. A broad range of programme components were used in these studies and whilst it is not possible to distinguish which of these components contributed most to the beneficial effects observed, our synthesis indicates the following to be promising policies and strategies:

·         school curriculum that includes healthy eating, physical activity and body image

·         increased sessions for physical activity and the development of fundamental movement skills throughout the school week

·         improvements in nutritional quality of the food supply in schools

·         environments and cultural practices that support children eating healthier foods and being active throughout each day

·         support for teachers and other staff to implement health promotion strategies and activities (e.g. professional development, capacity building activities)

·         parent support and home activities that encourage children to be more active, eat more nutritious foods and spend less time in screen based activities

However, study and evaluation designs need to be strengthened, and reporting extended to capture process and implementation factors, outcomes in relation to measures of equity, longer term outcomes, potential harms and costs.

Childhood obesity prevention research must now move towards identifying how effective intervention components can be embedded within health, education and care systems and achieve long term sustainable impacts.  

Résumé scientifique

Interventions for preventing obesity in children

Contexte

La prévention de l’obésité infantile est une priorité de santé publique internationale en raison des effets indéniables de l’obésité sur les maladies chroniques et aiguës, la santé générale, le développement et le bien-être. La base de connaissances internationales regroupant les stratégies, que les gouvernements, communautés et familles peuvent mettre en œuvre pour prévenir l’obésité et promouvoir la santé, s’est enrichie, mais reste imprécise.

Objectifs

Cette revue a pour objectif principal de mettre à jour la revue Cochrane précédente concernant la recherche sur la prévention de l’obésité infantile et de déterminer l’efficacité des interventions évaluées afin de prévenir l’obésité infantile, évaluée par un changement de l’Indice de Masse Corporelle (IMC). Les objectifs secondaires consistent à examiner les caractéristiques des programmes et les stratégies afin de répondre aux questions « Quel traitement est efficace pour qui, pour quelle(s) raisons(s) et à quel prix ? ».

Stratégie de recherche documentaire

Les recherches ont été répétées dans CENTRAL, MEDLINE, EMBASE, PsychINFO et CINAHL en mars 2010 et concernaient des sites Web pertinents. Des documents rédigés dans des langues non anglophones ont été inclus et des experts ont été contactés.

Critères de sélection

La revue contient des données issues d’études portant sur la prévention de l’obésité infantile ayant utilisé un plan d’étude contrôlée (avec ou sans randomisation). Des études ont été incluses si elles évaluaient des interventions, des politiques ou des programmes mis en place pendant douze semaines ou plus. Si les études étaient randomisées en cluster, 6 clusters étaient requis

Recueil et analyse des données

Deux auteurs de la revue ont extrait des données et évalué les risques de biais des études incluses, de façon indépendante. Les données ont été extraites lors de l’implémentation, des coûts, de l’équité et des résultats de l’intervention. Les mesures des résultats ont été regroupées selon qu’elles mesuraient l’adiposité, les comportements liés à l’activité physique (AP) ou au régime alimentaire. Les résultats indésirables ont été enregistrés. Une méta-analyse a été effectuée à l’aide de l’IMC disponible ou des données du score de l’IMC normalisé (IMCn) grâce à une analyse de sous-groupe réalisée par groupe d’âge (0 - 5, 6 - 12, 13 - 18 ans, correspondant aux étapes de développement et de l’enfance).

Résultats principaux

Cette revue contient 55 études (36 études supplémentaires ont été trouvées pour cette mise à jour). La majorité de ces études ciblaient des enfants âgés de 6 à 12 ans. La méta-analyse a inclus 37 études totalisant 27 946 enfants et a révélé que les programmes étaient efficaces en termes de réduction de l’adiposité, bien que seules quelques interventions individuelles étaient efficaces et que le niveau d’hétérogénéité observé était élevé (I2=82%). %). Dans l’ensemble, les enfants appartenant au groupe d’intervention présentaient une différence moyenne normalisée d’adiposité (mesurée en IMC ou IMCn) de - 0,15 kg/m2 (intervalle de confiance (IC) à 95 % : - 0,21 à - 0,09). Les effets de l’intervention par sous-groupes d’âge étaient de - 0,26 kg/m2 (IC à 95 % :- 0,53 à 0,00) (0 - 5 ans), - 0,15 kg/m2 (IC à 95 % : - 0,23 à - 0,08) (6 - 12 ans) et - 0,09 kg/m2 (IC à 95 % : - 0,20 à 0,03) (13 - 18 ans). L’hétérogénéité était visible dans l’ensemble des trois groupes d’âge et ne pouvait pas être expliquée par le type de randomisation ou le statut, la durée ou la configuration de l’intervention. Seules huit études ont révélé des effets indésirables et aucune preuve de résultats indésirables, comme l’identification de régimes alimentaires malsains, une prévalence accrue de l’insuffisance pondérale ou des sensibilités relatives à l’image corporelle. Les interventions ne semblaient pas aggraver les inégalités en termes de santé, bien que ce problème ait été examiné dans moins d’études.

Conclusions des auteurs

Nous avons trouvé des preuves solides pour corroborer les effets bénéfiques des programmes de prévention de l’obésité infantile sur l’IMC, plus particulièrement les programmes ciblant les enfants âgés de 6 à 12 ans. Toutefois, étant donné l’hétérogénéité inexpliquée et la probabilité d’un biais infime dans l’étude, ces découvertes doivent être interprétées avec précaution. Un large éventail de composants de programme a été utilisé dans ces études et bien qu’il soit impossible de distinguer le composant ayant le plus contribué aux effets bénéfiques observés, notre synthèse indique que les éléments suivants constitueront des politiques et des stratégies prometteuses :

·         programme scolaire incluant une alimentation saine, une activité physique et une image corporelle

·         augmentation du nombre de cours d’éducation physique et développement de gestes fondamentaux à effectuer tout au long de la semaine scolaire

·         améliorations de la qualité nutritionnelle de l’alimentation scolaire

·         environnements et pratiques culturelles qui amènent les enfants à consommer des aliments plus sains et à rester actif toute la journée

·         aide aux enseignants et autres employés scolaires à mettre en place des stratégies et des activités (par ex. : développement professionnel, activités de renforcement des capacités) visant à promouvoir la santé

·         soutien parental et activités domestiques encourageant les enfants à être plus actifs, à manger des aliments plus nutritifs et à passer moins de temps devant des écrans

Toutefois, la conception de l’étude et ses évaluations doivent être améliorées et sa notification étendue afin de capturer les facteurs de processus et d’implémentation, les résultats en termes de mesures d’équité, les résultats à plus long terme, les dangers et coûts éventuels..

La recherche portant sur la prévention de l’obésité infantile doit désormais privilégier la manière dont les composants d’intervention efficaces peuvent être intégrés à la santé, l’éducation et les systèmes de soins et obtenir ainsi des effets durables à long terme. .  

Resumo

Intervenções para a prevenção da obesidade infantil

Introdução

A prevenção da obesidade infantil é uma prioridade internacional de saúde pública devido ao seu impacto significante sobre doenças agudas e crônicas, sobre a saúde geral, sobre o desenvolvimento e o bem-estar. Tem havido um aumento na base de evidências internacionais sobre estratégias que podem ser usadas por governos, comunidades e famílias para prevenir a obesidade e promover a saúde infantil. Porém ainda existem incertezas nessa área.

Objetivos

Esta revisão atualizou a revisão Cochrane anterior sobre prevenção da obesidade infantil e avaliou a efetividade de intervenções para prevenir a obesidade infantil medida através de mudanças no Índice de Massa Corporal (IMC). Como objetivos secundários, foram avaliadas as características dos programas e das estratégias para responder as perguntas “O que funciona para quem, porque e com qual custo?”

Métodos de busca

As buscas foram refeitas nas bases CENTRAL, MEDLINE, EMBASE, PsychINFO e CINAHL em Março de 2010 e também buscamos websites relevantes. Incluímos artigos escritos em outros idiomas além do inglês e entramos em contatos com especialistas da área.

Critério de seleção

Esta revisão incluiu estudos de prevenção da obesidade infantil que utilizaram um desenho controlado (com ou sem randomização). Os estudos foram incluídos quando avaliaram as intervenções, políticas ou programas por pelo menos 12 semanas. Se os estudos fossem randomizados por aglomerados (clusters), pelo menos 6 clusters eram necessários.

Coleta dos dados e análises

Dois revisores extraíram os dados e analisaram de forma independente o risco de viés dos estudos incluídos. Foram extraídos dados sobre a implementação da intervenção, seus custos, equidade e desfechos. Os desfechos foram agrupados quanto à mensuração de medidas de adiposidade, atividade física (PA) ou dieta. Os desfechos adversos também foram coletados. Foi feita uma metanálise utilizando o IMC disponível ou valores do IMC padronizado (zIMC), com análise de subgrupos por faixa etária entre 0-5, 6-12, 13-18 anos de idade, correspondendo aos estágios do desenvolvimento infantil.

Principais resultados

Esta revisão incluiu um total de 55 estudos (sendo que 36 desses estudos vieram desta atualização). A maioria dos estudos incluiu crianças entre 6 a 12 anos. A metanálise incluiu 37 estudos com 27.946 crianças e demonstrou que os programas eram efetivos para reduzir a adiposidade. Porém, nem todas as intervenções foram efetivas e a heterogeneidade foi alta (I2 = 82%). Em geral, as crianças do grupo intervenção tiveram uma diferença média padronizada da adiposidade (medida como IMC ou zIMC) de -0.15kg/m2 (intervalo de confiança de 95% (IC): -0.21 a -0.09). Os efeitos da intervenção por subgrupos de idade foram: -0.26kg/m2 (IC 95%: -0.53 a 0.00) para crianças de 0-5 anos, -0.15kg/m2 (IC 95% -0.23 a -0.08) para crianças de 6-12 anos e -0.09kg/m2 (IC 95% -0.20 a 0.03) para crianças de 13-18 anos. A heterogeneidade foi evidente nas três faixas etárias e não foi justificada pela presença ou ausência de randomização ou pelo tipo, duração ou local da intervenção. Apenas 8 estudos relataram efeitos adversos. As intervenções não produziram desfechos adversos como práticas alimentares não saudáveis ou aumento na prevalência de crianças desnutridas ou com problemas de imagem corporal. As intervenções não parecem ter aumentado desigualdades de saúde; porém este desfecho foi avaliado em poucos estudos.

Conclusão dos autores

Encontramos fortes evidências indicando efeitos benéficos dos programas de prevenção de obesidade infantil sobre o IMC, especialmente nos programas dirigidos a crianças de 6-12 anos de idade. Entretanto estes achados devem ser interpretados com cautela devido à heterogeneidade inexplicável e a probabilidade de existir um viés decorrente de estudos com pequena casuística. Os estudos incluídos nesta revisão tinham programas com uma grande variedade de componentes. Apesar de não conseguirmos identificar quais dos componentes abaixo mais contribuíram para os efeitos benéficos observados, nossa síntese indica que as seguintes políticas e estratégias parecem ser promissoras:

·         um currículo escolar que inclua alimentação saudável, atividade física e imagem corporal

·         mais sessões de atividade física e de desenvolvimento de habilidades motoras fundamentais ao longo da semana escolar

·         melhora na qualidade nutricional dos alimentos fornecidos nas escolas

·         ambientes e práticas culturais que incentivem as crianças a comerem alimentos mais saudáveis e a serem fisicamente ativas ao longo de cada dia

·         apoio para os professores e outros funcionários para a implementação de estratégias e atividades de promoção de saúde (por ex. atividades de desenvolvimento e capacitação profissional)

·         apoio dos pais e atividades em casa que encorajem a criança a ser fisicamente ativa, a comer alimentos mais nutritivos e a gastar menos tempo com atividades em frente das telas da televisão, do computador e de jogos eletrônicos.

Porém, ainda é necessário melhorar o desenho dos estudos e das análises. Os estudos também precisam avaliar fatores relacionados a processos e a implementação, incluir desfechos relacionados com medidas de equidade e desfechos à longo prazo, assim como possíveis efeitos adversos e custos das intervenções.

As pesquisas sobre a prevenção da obesidade infantil precisam progredir no sentido de identificar como os componentes efetivos da intervenção podem ser incorporados dentro dos sistemas de saúde, de educação e de cuidados e como podem alcançar impactos sustentáveis a longo prazo.

Abstrak

Intervensi-intervensi untuk mencegah obesiti dalam golongan kanak- kanak.

Latar Belakang

Pencegahan obesiti dalam kalangan kanak-kanak merupakan keutamaan kesihatan awam antarabangsa. Ini adalah kerana kesan yang ketara obesiti pada penyakit-penyakit akut dan kronik, kesihatan, perkembangan dan kesejahteraan. Bukti antarabangsa yang asas bagi strategi yang dilaksanakan oleh kerajaan, masyarakat dan keluarga untuk mencegah obesiti, dan menggalakkan kesihatan, telah terkumpul tetapi masih tidak jelas

Matlamat

Tujuan utama kajian ini adalah untuk mengemaskini kajian Cochrane sebelum ini mengenai pencegahan obesiti kanak-kanak dan menentukan tahap keberkesanan intervensi-intervensi yang bertujuan untuk mencegah obesiti di kalangan kanak-kanak yang dinilai berdasarkan perubahan Indeks Jisim Badan (BMI - Body Mass Index). Tujuan yang kedua adalah untuk menilai ciri-ciri program dan strategi untuk menjawab persoalan "Intervensi apa memberi faedah untuk siapa, mengapa dan berapa kos yang diperlukan?"

Kaedah Pencarian

Carian telah dijalankan semula di CENTRAL, MEDLINE, EMBASE, PsychINFO dan CINAHL dan laman-laman web yang relevan pada Mac 2010. Kertas bukan berbahasa Inggeris telah dimasukkan dan pakar-pakar telah dihubungi.

Kriteria Pemilihan

Kajian ini merangkumi data daripada kajian pencegahan obesiti di kalangan kanak-kanak yang menggunakan kaedah kajian terkawal (secara rawak atau tidak rawak). Kajian-kajian lain dimasukkan jika mereka menilai intervensi-intervensi, polisi atau program yang diatur bagi dua belas minggu atau lebih. Jika kajian-kajian ini dirawakkan pada peringkat kelompok, paling sedikit 6 kelompok dikehendaki.

Pengumpulan Data dan Analisis

Dua orang penulis secara bebas telah mengekstrakan data dan menilai risiko berat sebelah daripada kajian-kajian yang dimasukkan dalam kajian sistematik ini. Data yang telah diekstrak adalah dalam hal pelaksanaan intervensi, kos, ekuiti dan hasil. Ukuran-ukuran hasil kajian telah dikumpulkan sama ada mereka diukur kadar tisu lemaknya (adiposity), tingkah laku yang berkaitan aktiviti fizikal (PA) atau tingkah laku yang berkaitan dengan pemakanan. Kesan buruk juga direkodkan.Satu meta-analisis telah dijalankan menggunakan skor Indeks Jisim Badan (BMI - Body Mass Index) atau BMI yang dibakukan (zBMI) dengan analisis subkumpulan (subgroup analysis) mengikut kumpulan umur (0-5, 6-12, 13-18 tahun, yang bersamaan dengan peringkat tetapan perkembangan kanak-kanak).

Keputusan Utama

Kajian sistematik ini merangkumi 55 kajian (36 kajian ditambahkan untuk mengemaskinikan kajian ini). Sebahagian besar kajian-kajian ini bersasaran kanak-kanak berumur 6-12 tahun. Meta-analisis ini merangkumi 37 kajian yang melibatkan 27,946 kanak-kanak dan menunjukkan bahawa program-program ini berkesan mengurangkan kadar tisu lemak, walaupun tidak kesemua intervensi memberi kesan, serta terdapat tahap kepelbagaian yang tinggi.(I <SUP> 2 </ SUP> = 82%). Secara keseluruhannya, kanak-kanak dalam kumpulan kajian ini mempunyai perbezaan purata baku (standardized mean difference) dalam kadar tisu lemak (diukur sebagai BMI atau zBMI) sebanyak -0.15kg / m2 (selang keyakinan 95% (CI ): -0.21 - -0.09). Kesan intervensi menurut kumpulan umur ialah -0.26kg / m2 (95% CI: -0.53 sehingga 0.00) (0-5 tahun), -0.15kg / m2 (95% CI sehingga -0.23 -0.08) (6-12 tahun), dan -0.09kg / m2 (95% CI -0.20 sehingga 0.03) (13-18 tahun). Kepelbagaian (heterogeneity) amat ketara dalam ketiga-tiga kumpulan umur dan tidak dapat dijelaskan oleh status rawak atau jenis, tempoh atau tempat intervensi dijalankan. Hanya lapan kajian memberi laporan kesan buruk dan tiada bukti kesan buruk seperti amalan pemakanan yang tidak sihat, peningkatan kejadian berat badan rendah atau sensitiviti imej berat badan. Intervensi-intervensi yang dijalankan tidak menunjukkan peningkatan ketidaksamaan kesihatan walaupun ini telah dilaporkan dalam beberapa kajian.

Kesimpulan Pengarang

Bukti kukuh telah ditemui yang menyokong program-program pencegahan obesiti dalam kalangan kanak-kanak berdasarkan BMI, terutamanya bagi program-program yang disasarkan kepada kanak-kanak yang berumur enam hingga 12 tahun. Walau bagaimanapun, penemuan ini seharusnya ditafsir dengan berhati-hati disebabkan kepelbagaian (heterogeneity) yang tidak dapat dijelaskan dan kemungkinan berlaku berat sebelah dalam kajian kecil. Komponen program yang luas telah digunakan dalam kajian-kajian ini dan sementara iainya tidak mungkin untuk membezakan yang mana yang memberikan sumbangan terbesar kepada kesan yang baik, kami menunjukkan hal-hal yang berikut menjadi polisi dan strategi yang menjanjikan:

kurikulum sekolah yang termasuk pengamalan pemakanan yang sihat serta aktiviti fizikal dan imej badan yang sihat.

menambahkan sesi untuk aktiviti fizikal dan pembangunan kemahiran pergerakan asas sepanjang minggu sekolah

peningkatan kualiti dan bekalan makanan di sekolah.

amalan persekitaran dan budaya yang menyokong anak-anak aktif sepanjang hari dan memakan makanan yang sihat

sokongan untuk guru-guru dan kakitangan lain untuk melaksanakan strategi-strategi dan aktiviti-aktiviti promosi kesihatan (contohnya, pembangunan profesional, aktiviti pembinaan keupayaan)

sokongan ibu bapa dan aktiviti-aktiviti yang dijalankan dalam rumah yang menggalakkan kanak-kanak untuk menjadi lebih aktif, memakan makanan yang menyihatkan (nutritious) dan mengurangkan aktiviti berasaskan skrin

Walau bagaimanapun, kaedah kajian dan penilaian perlu diperkukuhkan, dan laporan seharusnya dilanjutkan untuk memahami proses dan faktor-faktor pelaksanaan, serta hasil yang diperolehi untuk mengukur ekuiti, hasil jangka panjang, dan juga potensi mudarat serta kos.

Penyelidikan pencegahan obesity kanak-kanak perlu bergerak ke arah mengenal pasti keberkesanan hasil kajian yang boleh diterapkan dalam sistem kesihatan, pendidikan dan penjagaan serta mencapai kesan jangka panjang yang lestari. Â

Catatan terjemahan

摘要

兒童肥胖症預防之介入法

背景

預防兒童期肥胖為國際公眾健康的優先事宜,因為肥胖對急性及慢性疾病、一般健康、發展和安適感皆有重大的影響。雖然國際間應用政府、社會和家庭參與的策略得以預防肥胖和推廣健康的實證持續累積,但始終不明確。

目的

此文獻回顧主要目標著重在更新前一篇關於兒童期肥胖預防研究的考科藍文獻回顧,以及決定已獲評估之預防兒童肥胖介入法的有效程度。評估方式為觀察身體質量指數 (Body Mass Index , BMI) 的改變。次要目標為檢查計劃的特性和構成如何回答“何種方式適合何人,其原因及成本?”問題的策略。

搜尋策略

於2010年三月年重新搜尋CENTRAL, MEDLINE, EMBASE, PsychINFO 和 CINAHL同時也搜尋相關網站。包括非英語文獻以及接洽專家。

選擇標準

文獻回顧包括來自應用對照研究設計 (controlled study design) 的兒童期肥胖預防數據(隨機或非隨機)。若研究有評估介入方式、政策或已存在超過十二個月即被納入。若研究使用群集隨機分派(randomised at a cluster level),則需要六個群集。

資料收集與分析

兩個作者回顧文獻並獨立提取數據和評估所包括研究中的偏差風險。提取關於介入措施、成本、公平和結果的數據。結果測量質以其是否測量肥胖,運動相關行為或飲食相關行為來分類。發現負面結果。 一項後設分析應用可用的 BMI 或標準化 BMI (standardised BMI) (zBMI) 得分數據執行,分別以不同年齡層做子群分析 (0-5, 6-12, 13-18 歲,對應各發展階段和兒童期設定)。

主要結果

此文獻回顧包括55篇研究(此更新多增加了36篇研究)。大部份的研究針對年齡在6-12歲之間的兒童。 後設分析包括了 37篇研究,共 27,946 兒童參與,顯示了減少肥胖的計劃有效,雖然並非所有個別的介入都有效,並存有高度的觀測異質性(I2=82%)。 整體來說,在介入組的兒童有肥胖的標準化平均差 (standardised mean difference)(以BMI 或 zBMI測量)為 -0.15kg/m2 (95% 信賴區間 (CI): -0.21至-0.09)。 介入效果不同年齡次群則分別為0.26kg/m2 (95% CI:-0.53 至 0.00) (0-5歲), -0.15kg/m2 (95% CI -0.23 至 -0.08) (6-12歲), 和 -0.09kg/m2 (95% CI -0.20 至 0.03) (13-18歲)。異質性明顯存在於三個年齡群中,但無法用介入的隨機狀態、類型或時間長度和設定來解釋。只有八篇研究發現反效應且並無負面結果的證據,比如不健康的飲食方式,體重不足普遍性增加,或對身體外表形象敏感的情形。 介入並無顯示健康不平等的增加,雖然只有在少數研究中做此檢視。

作者結論

我們發現有力證據支持 BMI兒童肥胖預防計劃能夠帶來有益的效果,尤其是針對六至十二歲兒童的計劃。但由於未解釋的異質性以及存在小量研究偏差的可能型,應該要謹慎解釋這些結果。在這些研究中應用了範圍廣大的計劃構成成份,雖然無法從觀察到的有益效果之中分辨那些成份貢獻最大,我們的綜合結果仍指出如下幾項可為的政策和策略:

˙         學校課程包括健康飲食,運動和外表形象。

˙         增加學校每週運動和發展基本動作技巧的課堂次數。

˙         改善學校提供餐飲的營養品質。

·         從環境和文化實際操作中支持兒童每日攝取健康的食物以及從事體能活動。

˙         支持教師和其他員工制訂健康推廣策略和活動(比如 :專業培養和能力加強活動。)

˙         家長支援以及在家庭活動中鼓勵兒童更活躍,增加營養食物攝取以及減少待在螢幕前的活動。

無論如何,必須更加強研究和評估設計,並且報告的內容要延伸到涵蓋過程和實施因素、測量公平有關的結果、較長期結果、以及潛在傷害和成本。

兒童期肥胖預防研究現在必須朝著辨識如何將有效介入成份融入健康、教育和照護系統內以及獲得長期永續影響。

譯註

翻譯者﹕吳心文

本翻譯計畫由臺北醫學大學考科藍臺灣研究中心(Cochrane Taiwan)、台灣實證醫學學會及東亞考科藍聯盟(EACA)統籌執行
聯絡E-mail:cebm@tmu.edu.tw

摘要

儿童肥胖的预防措施

研究背景

儿童肥胖的预防是一个国际公共健康问题,尤其影响儿童急慢性疾病、总体健康情况、发育和幸福。政府、社区和家庭可以实施预防肥胖、促进健康策略的国际循证依据逐渐增多,但依然没有明确答案。

研究目的

本综述主要目的是更新之前的儿童肥胖研究的Cochrane综述,并通过BMI改变来评估预防肥胖的干预措施效果。次要目的是阐明干预措施、策略的特征,来回答“ 什么干预措施对谁发挥作用?为什么?成本是多少?”

检索策略

重新检索 CENTRAL, MEDLINE, EMBASE, PsychINFO 和 CINAHL数据库至2010年3月,并检索相关网站。非英语语言的文章也被纳入并联系作者。

标准/纳入排除标准

本综述纳入关于儿童肥胖预防的对照研究,无论是否随机。纳入研究的干预措施、政策或项目至少实施12周。如果研究是整群随机,至少包含6个群体的才可以纳入。

数据收集与分析

两位作者独立提取数据并对纳入研究进行偏倚风险评估。 资料提取内容包括:干预措施、成本、公平性和结局指标。结局指标按照是否测量肥胖倾向、体力活动相关行为、饮食相关行为进行分组。 记录不良事件。 BMI和标准化的BMI(zBMI)数据用于meta分析,不同的年龄分组(0-5,6-1213-18,与儿童的发育相符合)做亚组分析。

主要结果

本综述纳入55篇研究(36篇研究是本次更新的)。大部分研究的儿童年龄在6-12岁间。 包含37项研究27946名儿童的meta分析显示:方案能有效降低肥胖倾向,尽管不是每个单独的干预措施都是有效而且异质性很高(I2=82%)。 整体来讲,干预组的儿童肥胖倾向的标准化的均数差(BMI和zBMI)为-0.15kg/m2,95% CI: -0.21 to -0.09。年龄亚组分析显示干预措施的效应为: -0.26kg/m2 (95%CI:-0.53 to 0.00) (0-5 岁组), -0.15kg/m2 (95% CI -0.23 to -0.08) (6-12 岁组), and -0.09kg/m2 (95% CI -0.20 to 0.03) (13-18岁组)。三个年龄组的异质性都很显著,而且不能由随机状态和类型、干预实施场所和疗程所解释。 仅有8项研究报告了副作用情况,没有类似不健康节食、低体重流行或者对身体形象敏感等不良结局的发生。 干预措施似乎没有增加健康的不平等,尽管尽在很少的研究中阐述这个问题。

作者结论

我们发现有力证据支持儿童肥胖预防项目对BMI的效益,尤其是6-12岁儿童。但是,基于无法解释的异质性和小样本偏倚的可能性,这些结果还需要慎重解读。广泛的方案组成部分在这些研究中应用,同时难以区分哪一个组成部分最有效,我们的研究显示以下内容可以改善政策和策略:

        学校课程包括健康饮食、 体育活动和体型

        增加体育活动部分和发展基本的运动机能 在上学周

        提高学校食物供给的营养质量

        环境和文化 增加儿童食用健康食物和每天保持活力的环境和文化

        鼓励教师和其他工作者实施健康促进策略和活动(比如:专业发展和能力建设活动)

        父母支持、家庭鼓励儿童更加活跃,吃更多有营养的食物,少浪费时间在屏幕下的活动方面

但是,研究和设计还需加强,报告更全面的收集过程、实施因素、结局测量的公平性、长期效应、潜在危害和成本。

儿童肥胖预防研究要关注那些能融入健康、教育和关怀系统的,并具有长期稳定影响的干预措施。 

翻译注解

译者:王梅(辽宁中医药大学);审校:梁宁。翻译由北京中医药大学循证医学中心组织与提供。

Plain language summary

Interventions for preventing obesity in children

Childhood obesity can cause social, psychological and health problems, and is linked to obesity later in life and poor health outcomes as an adult.  Obesity development is related to physical activity and nutrition. To prevent obesity, 55 studies conducted internationally have looked at programmes aiming to improve either or both of these behaviours.  Although many studies were able to improve children’s nutrition or physical activity to some extent, only some studies were able to see an effect of the programme on children’s levels of fatness.  When we combined the studies, we were able to see that these programmes made a positive difference, but there was much variation between the study findings which we could not explain. Also, it appeared that the findings may be biased by missing small studies with negative findings. We also tried to work out why some programmes work better than others, and whether there was potential harm associated with children being involved in the programmes.  Although only a few studies looked at whether programmes were harmful, the results suggest that those obesity prevention strategies do not increase body image concerns, unhealthy dieting practices, level of underweight, or unhealthy attitudes to weight, and that all children can benefit.  It is important that more studies in very young children and adolescents are conducted to find out more about obesity prevention in these age groups, and also that we assess how long the intervention effects last.  Also, we need to develop ways of ensuring that research findings benefit all children by embedding the successful programme activities into everyday practices in homes, schools, child care settings, the health system and the wider community.     

Résumé simplifié

Interventions pour la prévention de l’obésité infantile

L’obésité infantile peut causer des problèmes sociaux, psychologiques et de santé. Elle est également liée à l’obésité à un âge plus avancé et à une mauvaise santé à l’âge adulte. Le développement de l’obésité est lié à l’activité physique et la nutrition. Pour prévenir l’obésité, 55 études réalisées à l’échelle internationale se sont penchées sur des programmes visant à améliorer l’un de ces comportements ou les deux. Bien que de nombreuses études aient permis d’améliorer la nutrition infantile ou l’activité physique à un certain niveau, seules quelques études ont pu confirmer les effets de ces programmes sur les niveaux d’adiposité des enfants. Lorsque nous avons combiné ces études, nous avons pu constater que ces programmes créaient une différence positive, mais les découvertes des études présentaient de nombreuses variations inexplicables. Les découvertes semblaient également biaisées en omettant des études réalisées à petite échelle et révélant des découvertes négatives. Nous avons aussi essayé de comprendre pourquoi certains programmes sont plus efficaces que d’autres et d’identifier la présence d’un éventuel danger encouru par les enfants suivant ces programmes. Bien que seules quelques études se soient intéressées à la dangerosité de ces programmes, les résultats ont suggéré que ces stratégies de prévention de l’obésité n’aggravaient pas les inquiétudes en termes d’image corporelle, de régimes alimentaires malsains, de niveaux d’insuffisance pondérale ou de comportements malsains et que tous les enfants pouvaient en bénéficier. Des études supplémentaires doivent être réalisées auprès des jeunes enfants et des adolescents, afin d’en savoir plus sur la prévention de l’obésité dans ces groupes d’âge, mais aussi afin que nous puissions évaluer la durée d’efficacité de ces interventions. Nous devons également développer des méthodes permettant de nous assurer que les découvertes de ces recherches profitent à tous les enfants en intégrant la réussite des activités proposées par ces programmes à des exercices quotidiens effectués à domicile, dans les écoles, dès la petite enfance, dans le système de santé et l’ensemble de la collectivité.  

Notes de traduction

Traduit par: French Cochrane Centre 29th August, 2013
Traduction financée par: Ministère du Travail, de l'Emploi et de la Santé Français

Resumo para leigos

Intervenções para a prevenção da obesidade infantil

A obesidade infantil pode causar problemas sociais, psicológicos de saúde além de estar associada com obesidade e problemas de saúde na vida adulta. O surgimento da obesidade está relacionado com a atividade física e nutrição. Para prevenir a obesidade, 55 estudos internacionais avaliaram programas que tentaram modificar a alimentação ou a atividade física. Apesar de muitos estudos terem melhorado a alimentação ou a atividade física das crianças até certo ponto, apenas alguns estudos conseguiram mostrar algum efeito destes programas sobre os níveis de adiposidade dessas crianças. Quando os resultados dos estudos foram combinados, pudemos ver que estes programas fizeram uma diferença positiva, mas também observamos a existência de uma grande variação entre os achados dos estudos e não foi possível esclarecer a causa para essa variação. Os resultados também podem terem sido enviesados pela falta de pequenos estudos com resultados negativos. Tentamos descobrir porque alguns programas funcionam melhor do que outros, e se haveria algum perigo para as crianças que participaram dos programas. Apesar de poucos estudos terem avaliado os possíveis riscos dos programas, os resultados sugerem que as estratégias para prevenção da obesidade infantil não aumentam problemas de imagem corporal, não aumentam a probabilidade de comportamentos alimentares não saudáveis, nem aumentam a taxa de crianças desnutridas ou de atitudes não saudáveis relacionadas ao próprio peso. É importante realizar mais estudos em crianças bem jovens e em adolescentes para se descobrir mais sobre a prevenção da obesidade nestes grupos etários. Também é importante verificar por quanto tempo os efeitos destas intervenções duram. Precisamos desenvolver meios para garantir que os resultados das pesquisas venham a beneficiar todas as crianças através da incorporação das atividades efetivas nas práticas diárias nos lares, nas escolas, nas creches, no sistema de saúde e em toda a comunidade.

Notas de tradução

Traduzido por: Brazilian Cochrane Centre
Tradução patrocinada por: None

Резюме на простом языке

Вмешательства для профилактики ожирения у детей

Ожирение у детей может вызвать социальные, психологические проблемы и проблемы со здоровьем; ожирение у детей связано с ожирением в дальнейшей жизни и с плохими исходами в состоянии здоровья во взрослом возрасте. Развитие ожирения определяется двумя факторами - степенью физической активности и питанием. На международном уровне было проведено 55 исследований, направленных на изучение мер по профилактике ожирения у детей, в программу которых входили меры воздействия на один или оба указанных фактора [поведения]. Несмотря на то, что во многих исследованиях меры по профилактике ожирения в определенной степени привели к улучшению питания детей или физической активности, только небольшое число исследований показали влияние проводимых программ на степень ожирения у детей. Когда мы объединили эти исследования, то обнаружили, что эти программы дали положительную разницу; но было много различий в результатах исследования, которые мы не могли объяснить. Также оказалось, что результаты могут быть смещены, в связи с тем, что не были включены небольшие (малые) исследования с отрицательными результатами.Мы также попытались выяснить, почему некоторые программы работают лучше, чем другие, и существует ли потенциальный вред для детей, участвующих в программах. Несмотря на то, что только несколько исследований изучали безопасность проводимых программ, результаты свидетельствуют, что предлагаемые стратегии профилактики ожирения не увеличивают обеспокоенность по поводу того, как выглядит тело, практику нездоровой диеты, уровень недостаточного веса или нездоровое отношение к весу, и что все дети могут получить пользу. Важно, чтобы проводилось больше исследований с участием очень маленьких детей или детей подросткового возраста, чтобы получить информацию о профилактике ожирения в этих возрастных группах, а также чтобы мы оценили, насколько длительно сохраняются эффекты вмешательства. Нам также необходимо разработать пути внедрения результатов научных исследований так, чтобы они становились полезными всем детям, встраивая успешные программы (виды деятельности) в ежедневную практику дома, в школах, в учреждениях по уходу за ребенком, в учреждениях здравоохранения и в обществе в целом.

Заметки по переводу

Перевод: Кораблева Анна Александровна. Редактирование: Зиганшина Лилия Евгеньевна. Координация проекта по переводу на русский язык: Казанский федеральный университет. По вопросам, связанным с этим переводом, пожалуйста, свяжитесь с нами по адресу: lezign@gmail.com

Laienverständliche Zusammenfassung

Interventionen zur Prävention von Adipositas bei Kindern

Fettleibigkeit (Adipositas) bei Kindern kann soziale, psychologische und gesundheitliche Probleme verursachen und wird mit Fettleibigkeit im späteren Leben und einem schlechten Gesundheitszustand im Erwachsenenalter in Verbindung gebracht. Die Entwicklung von Fettleibigkeit hängt mit dem Bewegungsverhalten und der Ernährung zusammen. 55 weltweit durchgeführte Studien haben sich mit Programmen beschäftigt, die auf die Verbesserung einer oder beider Verhaltensweisen abzielen, um Fettleibigkeit zu verhindern. Zwar konnten viele dieser Programme die Ernährung oder das Bewegungsverhalten bei Kindern in gewissem Umfang verbessern, jedoch stellten nur einige Studien eine Wirkung auf den Grad der Fettleibigkeit bei Kindern fest. Beim Kombinieren der Studienergebnisse sahen wir, dass diese Programme sich zwar positiv auswirkten, es gab jedoch viele Unterschiede zwischen den Ergebnissen der einzelnen Studien, die wir nicht erklären konnten. Auch hatte es den Anschein, als könnten die Ergebnisse verzerrt sein, weil kleinere Studien mit negativen Ergebnissen fehlten.Wir versuchten außerdem herauszufinden, warum einige Programme besser funktionieren als andere und ob solche Programme Kindern möglicherweise schaden können. Zwar beschäftigten sich nur wenige Studien mit möglichen Schäden, jedoch weisen die Ergebnisse darauf hin, dass diese Strategien zur Verhinderung von Fettleibigkeit nicht zu größeren Problemen mit dem Körperbild, ungesunden Ernährungsweisen, dem vermehrten Auftreten von Untergewicht oder einer ungesunden Einstellung zum Körpergewicht führen und dass alle Kinder von ihnen profitieren können. Es müssen weitere Studien mit sehr jungen Kindern und mit Jugendlichen durchgeführt werden, um mehr über die Verhinderung von Fettleibigkeit in diesen Altersgruppen herauszufinden. Es muss auch geklärt werden, wie lange die Wirkungen solcher Interventionen anhalten. Außerdem müssen wir dafür sorgen, dass die Forschungsergebnisse allen Kindern zugute kommen, indem wir wirksame Programme in den Alltag der Kinder zu Hause, in der Schule, in Betreuungseinrichtungen, im Gesundheitssystem und allgemein in der Gesellschaft einbetten.

Anmerkungen zur Übersetzung

S. Schmidt-Wussow, Koordination durch Cochrane Schweiz

Ringkasan bahasa mudah

Intervensi-intervensi untuk mencegah obesiti dalam golongan kanak- kanak.

Obesiti kanak-kanak boleh menyebabkan masalah sosial, psikologi dan kesihatan, dan dikaitkan dengan obesiti dan kesihatan yang kurang baik di kemudian hari dalam perkembangannya sebagai orang dewasa. Berlakunya obesiti adalah berkaitan dengan aktiviti fizikal dan pengambilan nutrisi. Untuk mencegah obesiti, 55 kajian dijalankan pada peringkat antarabangsa telah membandingkan program-program yang bertujuan untuk meningkatkan salah satu atau kedua-dua tingkah laku ini, aktiviti fizikal dan pengambilan nutrisi. Walaupun banyak kajian dapat menambahkan nutrisi kanak-kanak serta aktiviti fizikal mereka, hanya beberapa kajian dapat melihat kesannya pada tahap kegemukan kanak-kanak. Apabila kita menggabungkan kajian-kajian ini, kita dapat melihat bahawa program-program ini membuat perbezaan yang positif, tetapi terdapat banyak perbezaan diantara hasil kajian yang kita tidak boleh menerangkan. Selain itu, penemuan-penemuan ini mungkin berat sebelah kerana tertinggalnya kajian-kajian kecil dengan penemuan negatif. Kami juga cuba untuk mencari tahu mengapa sesetengah program kerja lebih baik daripada yang lain, dan sama ada terdapat kesan negatif yang mungkin berlaku yang berkaitan dengan penglibatan kanak-kanak dalam program-program ini. Walaupun hanya beberapa kajian yang menyelidiki kesan negatif program itu, keputusannya menunjukkan bahawa strategi mereka dalam pencegahan obesiti tidak meningkatkan kebimbangan imej badan, amalan pemakanan yang tidak sihat, tahap berat badan, atau sikap yang tidak sihat untuk berat badan, dan semua kanak-kanak boleh mengambil manfaat. Ia adalah penting untuk menjalankan lebih banyak kajian dikalangan kanak-kanak dan remaja untuk mengetahui lebih lanjut mengenai pencegahan obesiti dalam kumpulan umur ini serta berapa lama kesan program intervensi ini dapat tahan. Kita juga perlu membangunkan cara-cara untuk memastikan hasil penyelidikan yang bermanfaat kepada semua kanak-kanak dengan menerapkan aktiviti program yang berjaya ke dalam amalan sehari-hari di rumah, sekolah, persekitaran penjagaan kanak-kanak, sistem kesihatan dan masyarakat yang lebih luas.

Catatan terjemahan

Laički sažetak

Intervencije za sprječavanje pretilosti u djece

Pretilost u dječjoj dobi može uzrokovati društvene, psihološke i zdravstvene teškoće, i povezana je s pretilošću i lošijim zdravstvenim ishodima u odrasloj dobi.  Razvoj pretilosti je povezan s tjelesnom aktivnošću i prehranom. Cochrane sustavni pregled analizirao je literaturu o sprječavanju pretilosti u djece te je pronađeno 55 međunarodnih istraživanja je proučavalo programe koji unaprjeđuju tjelesnu aktivnost, prehranu ili obe navedene navike  Iako su mnogi programi uspjeli donekle unaprijediti prehrambene navike ili tjelesnu aktivnost djece, samo su neka istraživanja pokazala učinak takvih programa na debljinu. Prilikom kombiniranja navedenih istraživanja, vidljivo je da ovi programi imaju pozitivan utjecaj, ali razlike između rezultata istraživanjani su objašnjenje. Čini se također da su rezultati pristrani jer u literaturi nisu pronađene male studije s negativnim rezultatima. Autori su također pokušali objasniti zašto neki programi djeluju bolje od drugih, i postoji li ikakav štetan utjecaj na djeci uključenoj u navedene programe.  Iako je samo nekoliko istraživanja pratilo eventualnu štetnost programa, rezultati ukazuju na to da programi sprječavanja pretilosti ne uzrokuju iskrivljenu sliku o sebi, nezdrave prehrambene navike udjece, pothranjenost ili nezdrav odnos prema tjelesnoj masi, te da sva djeca mogu imati koristi od takvih programa.  Važno je provesti istraživanja na vrlo maloj djeci i adolescentima kako bise otkrilo više o prevenciji pretilosti u ovim dobnim skupinama, i kako bi se saznalo koliko traju učinci takvih intervencija.  Također je potrebno razviti načine da rezultati ovih istraživanja koriste svoj djeci uključivanjem aktivnosti iz programa u svakodnevnom životu kod kuće, školama, vrtićima, zdravstvenom sustavu i širem društvu.     

Bilješke prijevoda

Cochrane Hrvatska
Preveo: Marin Viđak
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr

எளியமொழிச் சுருக்கம்

குழந்தைகள் உடல் பருமன் தடுக்கும் முறைகள்

இளமைக்கால உடல்எடை பருமன் குழந்தைகளின் உடல், மனம் மற்றும் சமூக ஆரோக்கியத்தைப் பாதிக்கின்றது. இவை முதிர்வடைந்தபின் உடல் ஆரோக்கியத்திற்கு கேடினை விளைவிக்கும் அபாயமும் உள்ளது.  உடல்பருமன் அதிகரித்தல் உடல் செயல்பாடு மற்றும் ஊட்டசத்து தொடர்பானது. இந்த இரு விஷயங்களை மேம்படுத்தும் நோக்கத்துடன் உடல் பருமன் அதிகரித்தலை தடுக்க சர்வதேச அளவில் 55 ஆய்வுகள் நடத்தப்பட்டது.  பல ஆய்வுகள் ஓரளவிர்க்கு குழந்தைகள் ஊட்டசத்து அல்லது உடல் செயல்பாட்டை மேம்படுத்த முடிந்தது என்றாலும், சில ஆய்வுகளில் மட்டுமே குழந்தைகளின் உடல் பருமன் அளவில் மாற்றம் பார்க்க முடிந்தது.  நாங்கள் இந்த ஆவுகளை அனைத்தையும் இனைத்த போது,இந்த திட்டங்களால் திட்டமான வேறுபாடு காணமுடிந்தது, ஆனால் இந்த ஆய்வின் கண்டுபிடிப்புகள் இடையே உள்ள அதிக வேறுபாடுகளை எங்களால் விளக்க இயலவில்லை. மேலும் எதிர்மறை கண்டுபிடிப்புகள் உடைய சிறிய ஆராய்ச்சிகள் விடுபட்டதாள் முடிவுகள் ஒருதலைச் பட்சமாக இருக்கலாம். நங்கள் சில திட்டங்கள் மற்றதை விட ஏன் நன்றாக வேலைசெய்தது என்பதையும் அந்த திட்டங்களில் ஈடுபட்ட குழந்தைகளுக்கு ஏதேனும் தீங்கு இருந்தனவா என்பதையும் கண்டறிய முயற்சித்தோம்.  இத்திட்டங்கள் தீங்கு என அறிய ஒரு சில ஆய்வுகளை இருந்தன என்றாலும், உடல் பருமன் அதிகரித்தலை தடுக்கும் உத்திகள் உருவ அமைப்பு பற்றிய கவலைகள், ஆரோகியமற்ற உணவு கட்டுப்பாடு நடைமுறைகள், எடைகுறைவின் அளவு, அல்லது ஆரோகியமற்ற அணுகுமுறைகளை அதிகரிக்காது என்றும் அனைத்து குழந்தைகளுக்கும் பயனுள்ளதாக இருக்கும் என்றும் முடிவுகள் தெரிவித்தது.  அதிக ஆய்வுகள் இளம் குழந்தைகள் மற்றும் இளம் பருவத்தினர் மீது நடத்தப்பட்டு,குறிப்பிட்ட இந்த வயதினரிடத்தில் உடல் பருமன் அதிகரித்தலை தடுப்பதற்கு நடத்தப்பட்டது மற்றும் அந்த தலையீடுகள் எவ்வளவு காலம் நீடிக்கும் என்பதையும் அறிய நடத்தப்பட்டது என்பது முக்கியமாகும்.  மேலும் வீடுகள், பள்ளிகள், குழந்தை பராமரிப்பு அமைப்புகள், சுகாதார அமைப்பு மற்றும் பரந்த சமூகத்தில் அன்றாட வாழ்க்கை நடவடிக்கைகளில் இந்த ஆராய்ச்சியின் முடிவுகளை உட்பொதித்து அனைத்து குழந்தைகளும் பயனடையும் வண்ணம் வழிகளை உருவாக்க வேண்டும்.     

மொழிபெயர்ப்பு குறிப்புகள்

மொழிபெயர்ப்பு: இ. நவீன் குமார் மற்றும் சி.இ.பி.என்.அர் குழு

淺顯易懂的口語結論

兒童肥胖症預防之介入方式

兒童期肥胖可由社會、心理和健康方面問題造成,並且與未來成人時期的肥胖和不良健康結果有關聯。肥胖症的形成和運動與營養有關。為了預防肥胖,在國際間進行了 55篇研究針對改善以上兩者或其一行為為目標的計劃。雖然許多研究得以在某程度改善兒童的營養或運動,只有部份研究能夠看到計劃對兒童肥胖程度產生的效果。當我們綜合所有研究之後,發現這些計劃造成正面差異,但我們無法解釋在數個研究之間存在的許多差異。 並且,似乎研究結果也可能因為缺少顯示負面結果的少數研究而帶有偏差。我們並嘗試瞭解為何某些計劃的效果優於其他,再者瞭解讓兒童們參與這些計劃是否存有潛在傷害。 雖然只有少數研究追究這些計劃是否有害,結果顯示這些肥胖預防策略不至於增加對於外表形象的擔心、不健康的飲食習慣、重量不足程度、或對體重不健康的態度,並且所有兒童都能受益。重要的一點,必須執行更多的研究於幼童和青少年,以便更深入探索如何在這兩個年齡層預防肥胖,並評估介入的影響能夠維持多久。而且我們必須開發一些能把成功計劃活動融入日常生活中的方式-包括家庭、學校、兒童保育場所、衛生體系和更廣泛的公眾-以確定研究結果能使所有兒童受益。

譯註

翻譯者﹕吳心文

本翻譯計畫由臺北醫學大學考科藍臺灣研究中心(Cochrane Taiwan)、台灣實證醫學學會及東亞考科藍聯盟(EACA)統籌執行
聯絡E-mail:cebm@tmu.edu.tw

概要

儿童肥胖的预防措施

儿童期肥胖会引起社会、心理和健康问题,并且与成年后肥胖和不良健康结局有一定联系。 肥胖的发生与体育活动和营养状况有关。为了预防肥胖,实施了55项国际研究来观察改善这些行为方式的方案。 尽管很多研究能够在某种程度上改善儿童的营养或体育活动,但是只有少数研究能观察到方案对儿童肥胖水平的效应。 当我们合并这些研究时,我们可以看到这些研究都有显著差异,但是研究结果间差别很大,这一点我们很难解释。同时,似乎这样的结果由于缺乏纳入小样本研究和阴性结果存在偏倚。 我们尝试解释为什么一些方案比其他的方案效果好,并且是否对参与此研究的儿童有潜在的危害。 尽管很少研究了方案是否有害,但是结果显示那些肥胖预防策略不能增加对身体形象问题,不健康的节食,体重不足的程度,或者对体重的不健康态度的影响,并且所有的儿童都能获益。 更多的研究关注儿童和青少年并发现这个年龄段预防肥胖的更多措施和干预措施效应持续时间显得尤为重要。 同时,我们也要发展以下方式来保证研究结果利益所有儿童,通过将项目成功融入他们每天家庭、学校、幼儿机构、健康系统和更广泛的社区领域。     

翻译注解

译者:王梅(辽宁中医药大学);审校:梁宁。翻译由北京中医药大学循证医学中心组织与提供。

Streszczenie prostym językiem

Interwencje ukierunkowane na zapobieganie rozwojowi otyłości wśród dzieci

Otyłość w dzieciństwie może powodować problemy społeczne, psychologiczne i zdrowotne, a ponadto ma związek z otyłością i złym stanem zdrowia w wieku dorosłym.  Rozwój otyłości związany jest z aktywnością fizyczną oraz sposobem odżywiania. Na świecie przeprowadzono 55 badań, w których oceniano programy mające korzystnie wpływać na jeden lub oba te elementy.  Mimo że wiele badań wskazywało na różnego stopnia poprawę w zakresie żywienia dzieci lub ich aktywności fizycznej, to tylko w niektórych udało się stwierdzić wpływ danego programu na stopień otyłości.  Po połączeniu badań korzystny wpływ programów stał się widoczny, ale pomiędzy wynikami poszczególnych badań były duże różnice, których nie potrafiliśmy wyjaśnić. Ponadto wydaje się, że wnioski mogą być obarczone błędem wynikającym z braku małych badań z negatywnymi wynikami. Próbowaliśmy również sprawdzić, dlaczego niektóre programy działają lepiej od innych oraz czy udział dzieci w programach może być potencjalnie szkodliwy.  Tylko w kilku badaniach próbowano ocenić negatywne skutki programów; ich wyniki sugerują, że analizowane strategie profilaktyki otyłości nie nasilają obaw związanych z wyglądem, nie prowadzą do niezdrowych nawyków żywieniowych, do niedowagi ani do niezdrowych postaw w odniesieniu do wagi ciała, oraz że korzyści mogą odnieść wszystkie dzieci.  Potrzeba więcej badań wśród małych dzieci oraz młodzieży, aby lepiej ocenić efekty profilaktyki otyłości w tych grupach wiekowych; należy też sprawdzić, jak długo utrzymują się efekty interwencji.  Ponadto musimy znaleźć sposób, jak przełożyć wyniki badań na korzyści dla wszystkich dzieci poprzez wdrażanie skutecznych działań do codziennej praktyki w domu, szkole, placówkach opieki nad dzieckiem, systemie ochrony zdrowia oraz w szerszej społeczności. 

Uwagi do tłumaczenia

Tłumaczenie Magdalena Koperny, Redakcja Łukasz Strzeszyński

Background

Obesity prevention is an international public health priority and there is growing evidence of the impact of overweight and obesity on short- and long-term functioning, health and well being. In children, adolescents and adults in a wide range of countries (including more recently, middle- and low-income countries) high and increasing rates of overweight and obesity have been reported over the last 20 to 30 years (Lobstein 2004; Popkin 2004; Wang 2001; Wang 2006a). Internationally, childhood obesity rates continue to rise in some countries (e.g. Mexico, India, China, Canada), although there is emerging evidence of a slowing of this increase or a plateauing in some age groups across European countries, the US (Rokholm 2010) and Australia (Nichols 2011; Olds 2010). The evidence is strong however, that once obesity is established, it is both difficult to reverse through interventions (Luttikhuis 2009), and tracks through to adulthood (Singh 2008; Whitaker 1997), strengthening the case for primary prevention. Governments internationally are acting to implement strategies for obesity prevention and, behaviour change relating to diet and physical activity is an integral component of any such strategy.  However, behaviour change interventions cannot operate in isolation from the context and the interplay between the obesogenic environment and the child is an important consideration.  

Childhood obesity has been described as the primary childhood health problem in developed nations (Ebbeling 2002), having been linked to many serious physical, social and psychological consequences. These include increased risk of cardiovascular dysfunction (Freedman 1999), type 2 diabetes (Fagot-Campagna 2000), and pulmonary (Figueroa-Muñoz 2001), hepatic (Strauss 2000), renal (Adelman 2001) and musculoskeletal (Chan 2009) complications; lower health-related quality of life (Tsiros 2009); negative emotional states such as sadness, loneliness, and nervousness, and increased likelihood of engagement in high-risk behaviours (Strauss 2000a); and undesirable stereotyping including perceptions of poor health, academic and social ineptness, poor hygiene and laziness (Hill 1995).

Obesity prevalence is also inextricably linked to the degree of relative social inequality, with greater social inequality associated with a higher risk of obesity in most developed countries but in most developing countries the reverse relationship is observed (Monteiro 2004). It is therefore critical that in preventing obesity we are also reducing the associated gap in health inequalities, ensuring that interventions do not inadvertently have more favourable outcomes in those with a more socio-economically advantaged position in society. The available knowledge base on which to develop a platform of obesity prevention action and base decisions about appropriate public health interventions to reduce the risk of obesity across the whole population, or targeted towards those at greatest risk, still remains limited (Gortmaker 2011). The impact of interventions on preventing obesity, the extent that they work equitably, their safety  and how they work, remains poorly understood.

Description of the condition

Overweight and obesity are terms used to describe an excess of adiposity (or fatness) above the ideal for good health. Current expert opinion supports the use of body mass index (BMI) cutoff points to determine weight status (as healthy weight, overweight or obese) for children and adolescents and several standard BMI cut-offs have been developed (Cole 2000; Cole 2007; de Onis 2004; de Onis 2007). Despite this, there is no consistent application of this methodology by experts and a variety of percentile based methods are also used, which can make it difficult to compare studies that have used different measures and weight outcomes.

Overweight and obesity in childhood are known to have significant impact on both physical and psychosocial health (reviewed in Lobstein 2004). Indeed, many of the cardiovascular consequences that characterise adult-onset obesity are preceded by abnormalities that begin in childhood. Hyperlipidaemia, hypertension and abnormal glucose tolerance occur with increased frequency in obese children and adolescents (Freedman 1999) and children with type 2 diabetes have also been identified (Arslanian 2002). In addition, obesity in childhood and adolescence are known to be independent risk factors for adult obesity (Must 1992; Must 1999; Power 1997; Singh 2008; Whitaker 1997), underpinning the importance of obesity prevention efforts.

Modifiable determinants of childhood obesity

Obesity develops from a sustained positive energy imbalance and a variety of genetic, behavioural, cultural, environmental and economic factors have been implicated in its development (reviewed in Lobstein 2004).The interplay of these factors is complex and has been the focus of considerable research, however, the burden of obesity is not experienced uniformly across a population, with the highest levels of the condition experienced by those most disadvantaged. In developed countries there is a significant trend observed between obesity and lower socio-economic status, while in some developing countries the contrary is found, with children from relatively affluent families more vulnerable to obesity.

Description of the intervention

This review involves assessing educational, behavioural and health promotion interventions. The terms "intervention" and "programme" are used interchangeably throughout this review. The Ottawa Charter defines four action areas for health promotion: 1) Actions to develop personal skills, which are actions targeted at individual skills, behaviours, or knowledge and beliefs; 2) Actions to strengthen community actions, which are actions targeted at communities and include environmental and settings-based approaches to health promotion; 3) Actions to reorient health services, which are actions within the health sector and relate to the delivery of services; and 4) Actions to build healthy public policy and create supportive environments, which are inter-sectoral in nature and relate to creating physical, social and policy environments that promote health.

Why it is important to do this review

Governments internationally are being urged to take action to prevent childhood obesity and to address the underlying determinants of the condition. To provide decision-makers with high quality research evidence to inform their planning and resource allocation, this review aims to provide an update of the evidence from studies designed to compare the effect of interventions to prevent childhood obesity with the effect of receiving an alternative intervention or no intervention. We aimed to update the previous review (Summerbell 2005) which concluded that many diet and exercise interventions to prevent obesity in children appeared ineffective in preventing weight gain, but could be effective in promoting a healthy diet and increased levels of physical activity. The previous review also urged reconsideration of the appropriateness of study durations, designs and intervention intensity as well as making recommendations in relation to comprehensive reporting of studies. Overall however, although there was insufficient evidence to determine that any one particular programme could prevent obesity in children, the evidence suggested that comprehensive strategies to increase the healthiness of children’s diets and their physical activity levels, coupled with psycho-social support and environmental change were most promising. We incorporated research evidence that has been published since that time and is also consistent with emerging issues in relation to evidence reviews and synthesis (Doak 2009; Tugwell 2010). In addition, to meet the growing demand from public health and health promotion practitioners and decision makers, we have attempted to include information related to not only the impact of interventions on preventing obesity, but also information related to how outcomes were achieved, how interventions were implemented, the context in which they were implemented (Wang 2006) and the extent to which they work equitably (Tugwell 2010). This new aspect of the review was partly guided by the Systematic Reviews of Health Promotion and Public Health Interventions (Armstrong 2007), more recent recommendations for complex reviews and useful evidence for decision makers (Waters 2011), and informed by expert opinion.

Objectives

The main objective of the review is to update the previous review and determine the effectiveness of educational, health promotion and/or psychological/family/behavioural therapy/counselling/management interventions which focus on diet, physical activity or lifestyle support, or both and were designed, or had an underlying intention to prevent obesity/further weight gain, in children. Specific objectives include:

  • Evaluation of the effect of dietary educational interventions versus control on changes in BMI, prevalence of obesity, rate of weight gain and other outcomes among children under 18 years

  • Evaluation of the effect of physical activity interventions versus control on changes in BMI, prevalence of obesity and rate of weight gain and other outcomes among children under 18 years

  • Evaluation of the effect of dietary educational interventions versus physical activity intervention on changes in BMI, prevalence of obesity and rate of weight gain and other outcomes among children under 18 years

  • Evaluation of combined effects of dietary educational interventions and physical activity interventions versus control on changes in BMI, prevalence of obesity and rate of weight gain and other outcomes among children under 18 years

Secondary aims are to describe the interventions in order to identify the characteristics of the interventions that are related to the reported outcomes. Specific objectives include:

  • Evaluation of demographic characteristics of participants (socio-economic status, gender, age, ethnicity, geographical location, etc.)

  • Evaluation of particular process indicators (i.e. those that describe why and how a particular intervention has worked)

  • Evaluation of contextual factors contributing to the performance of the intervention

  • Evaluation of the maintenance of short-term changes beyond 12 weeks

Methods

Criteria for considering studies for this review

Types of studies

We included data from controlled trials (with or without randomisation), with a minimum duration of 12 weeks, that were designed, or had an underlying intention to prevent obesity. The terms research "studies" and "trials" also represent programme/demonstration project evaluations and are used interchangeably throughout this review. In the previous version of this review, studies were categorised into long-term (at least one year) and short-term (at least 12 weeks), referring to the length of the intervention itself or to a combination of the intervention with a follow-up phase. For this review update, studies were required to have minimum intervention duration of 12 weeks and we categorised studies based on target age group rather than study duration, though length of duration has been captured and integrated into the analysis.

We accepted studies in which individuals or groups of individuals were randomised, however, for those with group randomisation we accepted only studies with six or more groups.

Types of participants

We included studies of children less than 18 years at the commencement of the study, including studies where children were part of a family group receiving the intervention if data could be extracted separately for the children. Studies with interventions that included children who were already obese were included to reflect a public health approach that recognises the prevalence of a range of weight within the general population of children, provided that obesity was not a requirement for children to be included in the study. Studies that only enrolled children who were obese at baseline were considered to be focused toward treatment rather than prevention and were therefore excluded. Interventions for treating obesity in children have been reviewed in another Cochrane review (Luttikhuis 2009). We excluded studies of interventions designed to prevent obesity in pregnant women and studies designed for children with a critical illness or severe co-morbidities.

Types of interventions

Strategies

We included educational, health promotion (this would include "community-based interventions"), psychological/family/behavioural therapy/counselling/management strategies.

Interventions included

We included studies of interventions or programmes that involved diet and nutrition, exercise and physical activity, lifestyle and social support.

Setting

Interventions within the community, school and out of school hours care, home, childcare or preschool/nursery/kindergarten were eligible.

Types of comparison

We included studies that compared diet or physical activity interventions, or both with a non-intervention control group who received usual care or another active intervention (i.e. head-to-head comparisons).

Intervention personnel

There was no restriction on who delivered the interventions, for example, researchers, primary care physicians (general practitioners), nutrition/diet professionals, teachers, physical activity professionals, health promotion agencies, health departments, or others.

Indicators of theory and process

We collected data on indicators of intervention process and evaluation, health promotion theory underpinning intervention design, modes of strategies and attrition rates from these trials. We compared where possible, whether the effect of the intervention varied according to these factors. This information was included in descriptive analyses and used to guide the interpretation of findings and recommendations. 

Interventions excluded

We excluded studies of interventions designed specifically for the treatment of childhood obesity and studies designed to treat eating disorders such as anorexia and bulimia nervosa.

Types of outcome measures

To be included, studies had to report one or more of the following primary review outcomes, presenting a baseline and a post-intervention measurement. These data were used to evaluate change from baseline if not reported within the study.

Primary outcomes
  • weight and height

  • per cent fat content

  • BMI

  • ponderal index

  • skin-fold thickness

  • prevalence of overweight and obesity

Secondary outcomes
  • activity levels

  • dietary intake (using validated measures such as diaries etc)

  • change in knowledge

  • environment change (such as food provision service)

  • stakeholders views of the intervention and other evaluation findings

  • measures of self-esteem, health status and well being, quality of life

  • harm associated with the process or outcomes of the intervention

  • cost effectiveness/costs of the intervention

Search methods for identification of studies

Electronic searches

For this updated search in March 2010 and searches for previous versions of this review, we searched the following databases:

  • Cochrane Central register of controlled trials (CENTRAL)

  • MEDLINE

  • EMBASE

  • PsycINFO

  • CINAHL

Studies were not excluded on the basis of language. Complete search strategies and search dates for each database can be found in the Appendices. The search strategies used for this update (Appendix 1), as well as those used for the previous published version of this review, (Appendix 2) are both included.

Searching other resources

Websites searched

We searched the following websites during March 2010 to identify other systematic reviews or studies that may have been missed in the database searches.

  • The Campbell Library

  • The Centre for Reviews and Dissemination (CRD)

  • The Cochrane Library, including DARE

  • Health evidence, Canada, http://www.health-evidence.ca/

  • NHS Evidence

  • The Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI Centre) database of health promotion research

  • World Health Organization International Clinical Trials Registry Platform (ICTRP)

  • Google (included to increase the potential for identifying relevant grey literature for inclusion)

Combinations of key words relating to population (child*, infant*, “young children”, adolescen*, teenag*, “school* children”, youth), intervention (“obesity prevention”, “prevention of obesity”, diet, “health promotion”, nutrition, exerci*, “physical activity”, intervention) and outcomes (weight, height, “fat content”, “body mass index”, “ponderal index”, “skinfold thickness”) informed the searching.

Contacting experts (advisory group)

A Review Advisory Group was formed to aid in the decisions made for the progression of revising the scope of the protocol and the subsequent review, as well as hallmarks for useful review components to aid its relevance to policy and programme decision making. This group consists of six members who are, and have contact with, experts from the research, advocacy and policy sectors in the field of obesity prevention. Advisory group members are named in the Acknowledgements section.

Reference lists checked

We scanned the reference lists of systematic reviews (identified from searches detailed above) that included information on interventions for the prevention of childhood obesity to identify potential additional studies for inclusion.

Data collection and analysis

Selection of studies

For this update of the review, we included studies published during or after 2005. Included and excluded studies published between 1990 and 2005 that were identified for previous versions of this review were carried forward to this review. Articles were rejected on initial screen when the review author determined from the title and abstract that the article was not a report of a controlled trial (randomised or non-randomised); or the trial did not address an intervention which aims to improve food intake, physical activity and/or prevent obesity; or the trial was exclusively in individuals older than 18 years, pregnant women/young adults, or the critically ill; or the trial was of less than 12 weeks duration; or the intervention was concerned with the treatment of eating disorders such as anorexia nervosa and bulimia nervosa.

When a title or abstract could not be rejected with certainty, we obtained the full text of the article for further evaluation. Two review authors independently assessed the studies for inclusion and resolved differences between their assessments by discussion and, when necessary, in consultation with a third review author.

Data extraction and management

We developed a data extraction form, based on the Effective Public Health Practice Project Quality Assessment Tool for quantitative studies (Thomas 2003).

This review update introduced additional data extraction items specifically related to implementation. These have now been included in the Characteristics of included studies tables grouped under the category of implementation-related factors. We included quality criteria questions relating to randomised controlled trials (RCTs), as well as non-randomised controlled trials in the data extraction form. We used the PROGRESS checklist to collect data relevant for equity (Ueffing 2009). We extracted data from related publications that reported findings on the process evaluation or the design of the intervention. Two review authors independently extracted data from included papers into the data extraction form for each study and managed numerical data for analysis in an Excel spreadsheet.

Assessment of risk of bias in included studies

We assessed the risk of bias of included studies using the 'Risk of bias' tool developed by The Cochrane Collaboration (Higgins 2008). This includes five domains of bias: selection, performance, attrition, detection and reporting, as well as an ‘other bias’ category to capture other potential threats to validity. The guidance provided with the EPOC (Effective Practice and Organisation of Care) 'Risk of bias' tool for studies with a separate control group (Cochrane EPOC 2009) was also used to guide assessments for non-randomised studies. At least two review authors assessed the risk of bias for each study. Review authors were not blinded with respect to study authors, institution or journal as they were familiar with the literature. We used discussion and consensus to resolve any disagreements.

Selection bias included an assessment of adequate sequence generation as well as allocation concealment. We assessed sequence generation to be at low risk when studies clearly specified a method for generating a truly random sequence. We assessed allocation concealment to be at low risk for RCTs if the method used to ensure that investigators enrolling participants could not predict group assignment was described. Cluster RCTs received a rating of low risk of bias for this domain if the unit of allocation was by institution or community and allocation was performed on all units at the start of the study, as recommended by the EPOC 'Risk of bias' tool for studies with a separate control group. We assessed all non randomised studies as high risk of bias for both sequence generation and allocation concealment. Performance and detection bias was incorporated under the one domain in the 'Risk of bias' tool: blinding. We assessed this to be low risk for studies that reported blinding of outcome assessors, and high risk for studies reporting that outcome assessors were not blinded. We assessed studies as low risk for attrition bias if an adequate description of participant flow through the study was provided, the proportion of missing outcome data was relatively balanced between groups and the reasons for missing outcome data were provided, relatively balanced between groups and considered unlikely to bias the results. We assessed studies as low risk of reporting bias when a published protocol was available and all specified outcomes were included in the study report; studies without a published protocol, we assessed as unclear. When an outcome measure was specified and the results were not reported either at baseline or at follow-up, we considered that study as being at high risk of reporting bias.

Measures of treatment effect

All reported outcomes were taken directly from studies. We conducted a to investigate the impact of included interventions on BMI. When considering the most appropriate metric for meta-analysis, we found that BMI or zBMI (standardised body mass index) were the most consistently reported measures. We did not undertake a meta-analysis of the effects of the interventions on prevalence of overweight or obesity due to two factors:it was not reported in the majority of the studies, and there were highly variable methods used for the classification of overweight and obesity (e.g. overweight variably classified as BMI ≥ 90th percentile or BMI 90th < BMI <97th percentile, or overweight classified as BMI > 85% for age and sex; obesity classified using 95th percentile National Center for Health Statistics triceps-skinfold thickness cut-offs; percentage of overweight classified by comparing the BMI of the participant with the relevant 50th BMI percentile based on the gender and age of the participant; prevalence of overweight/obesity classified as BMI > 85th percentile; overweight or obese classified as > 91st centile; obesity classified as BMI > 95th percentile; obesity classified as BMI > 97th percentile; weight status classified using the IOTF (International Obesity Task Force) BMI cut-offs), and also variability in the reporting of prevalence rates. Given that different methods of classification of weight status in children produce very different prevalence estimates, and limit comparisons between studies, we therefore, did not perform a meta-analysis of this outcome. The data are however included in the narrative synthesis.

For the meta-analysis on BMI/zBMI, we did not perform any re-calculations of means. If it was not reported, we derived the standard deviation (SD) from the reported standard error (SE) of the mean, or 95% confidence intervals (CIs) using the equations provided in Chapter 9 of the Cochrane Handbook for Systematic Reviews of Interventions (Deeks 2008). We then used means and SDs to determine standardised mean differences (SMDs) between groups for use in the meta-analysis.  Where no SE was provided for follow-up data, we imputed the SD from either the baseline values or other included studies of similar size and target population (one occasion only). For studies which reported more than one intervention arm, we presented the data for each intervention arm compared with the control arm, with the number of participants in the control arm halved to ensure no double counting. Where the trial reported data immediately post-intervention and at a subsequent follow-up time point, only the data immediately post-intervention is included in the meta-analysis. Analysis was conducted stratified by age group and we used the I2 statistic to provide a measure of heterogeneity. Analyses were conducted using Review Manager (RevMan) 5.1 software.  For studies not included in the meta-analyses, findings are described in tables and in the text. Unless otherwise stated, all data are presented in the format of mean and SD 95% CIs. Results with P > 0.05 are reported as not significant (ns) and P values are not given if they were unreported in the original study.

We also sought factors related to intervention development, implementation process, equity and sustainability. These included methods of stakeholder engagement, descriptions of formative research, pilot studies and on-going evaluation; modification of the programme, programme reach, completeness of the implementation of the intervention, outcomes against PROGRESS categories, and maintenance of the programme after the intervention ceased. This information is presented in the Characteristics of included studies tables and summarised in the results section.

Data synthesis

We grouped studies primarily according to target age group (0-5 years, 6-12 years and 13-18 years). Within these categories, we summarised studies in relation to effectiveness, implementation, and maintenance or sustainability of effects. We summarised effectiveness results according to outcomes (measures of adiposity, behaviour, impact on equity and adverse/unintended effects), as well as the design and theoretical basis of studies. We summarised implementation information according to whether process evaluations were conducted, reporting of the resources and other factors needed for implementation, and whether specific strategies were included to address disadvantage or diversity.

Subgroup analysis and investigation of heterogeneity

We explored heterogeneity by age group, setting of intervention, risk of bias, duration of intervention (12 weeks versus >12 weeks) and by randomisation. Studies did not report intervention intensity or complexity at the level required to be able to explore heterogeneity by these factors in a meaningful way.

Results

Description of studies

Results of the search

Figure 1 describes how the references identified through the searches were processed for this update as well as previous versions of the review.

Figure 1.

Quorom statement flow diagram - Interventions for preventing obesity in children

In summary, for this review update, the hits identified from the searches of electronic databases (MEDLINE 7,194, CINAHL 1,459, PsycINFO 783, EMBASE 6,772 CENTRAL 1,201) were combined (n = 17,409) and de-duplicated (n = 13,734). These list hits were then de-duplicated against the hits identified for the previous version of this review. This reduced list of hits were then screened on titles and abstracts (review author initials: LP). Articles were rejected on initial screen if the review author could determine from the title and abstract that the article did not meet the inclusion criteria for this review.

The review authors (EW, KC, LP, RA, GY, CS, BH, AdS-S) independently assessed full-text copies of 117 papers against the inclusion criteria. Thirty six new studies have been included in this version of the review, giving a total number of 55 included studies (Amaro 2006; Coleman 2005; Donnelly 2009; Ebbeling 2006; Fernandes 2009; Fitzgibbon 2005; Fitzgibbon 2006; Foster 2008; Gentile 2009; Gutin 2008; Haerens 2006; Hamelink-Basteen 2008; Harrison 2006; Jouret 2009; Keller 2009; Kipping 2008; Lazaar 2007; Macias-Cervantes 2009; Marcus 2009; Paineau 2008; Pate 2005; Patrick 2006; Peralta 2009; Reed 2008; Reilly 2006; Robbins 2006; Rodearmel 2006; Salmon 2008; Sanigorski 2008; Sichieri 2009; Simon 2008; Singh 2009; Spiegel 2006; Taylor 2008; Vizcaino 2008; Webber 2008).

The excluded studies included those that did not meet the minimum duration of 12 weeks, studies with a cluster allocation of fewer than six groups, those that were studies of treatment for obesity rather than prevention, studies recruiting only obese participants, and those not reporting at least one of the primary outcomes of interest for this review (weight and height, per cent fat content, BMI, ponderal index, skin-fold thickness or prevalence of overweight and obesity). In a change to the inclusion criteria for this review update, we excluded studies with an intervention period of less than 12 weeks, even if the follow-up period extended beyond 12 weeks (Danielzik 2005). The last published version of this review included 22 studies, however, three of these studies have now been excluded (Donnelly 1996; Flores 1995; Robinson 1999) because they were studies with a cluster allocation of fewer than six groups, and therefore should not have been included in the last version of this review. Therefore, only 19 of the 22 previously included studies were carried forward into this review. Studies identified that were ongoing at the time of the search have been listed under Characteristics of ongoing studies. While some studies appear to have completed based on dates listed in study records, studies with no available outcome data published at the time of the search remain classified as ongoing studies to ensure this information is available to end-users of this review.

Included studies

Fifty of the 55 included studies were set in high-income countries, as classified by the World Bank economic classification. Of these, 26 studies were conducted in the USA, two in Canada, six in the United Kingdom, four in France, two in Germany, two in the Netherlands, one each in Belgium, Sweden, Italy and Spain, and four in Australia/New Zealand. Four studies were conducted in upper-middle-income countries (two in Brazil, one each in Chile and Mexico), and one study was conducted in Thailand, a lower-middle-income country. Of the included studies, eight targeted children aged 0-5 years, 39 targeted children aged 6 to -12 years, and eight studies targeted children aged 13-18 years (Table 1).  Of the 55 included studies, 41 were interventions implemented for 12 months or less, seven for 1 to 2 years, and seven were implemented for more than two years.  We remain mindful of the potential weaknesses (and bias) of data derived from short-term behaviour change studies and this will be a consideration in the 'Risk of bias' assessment and during interpretation of findings. Due to the range of interventions included in this review, descriptive details will be integrated into the results section and details by study can be found in the Characteristics of included studies tables, as well as the Study Design Table (Table 1). Details of outcomes reported in studies can be found in Table 2 for 0-5 year olds, Table 3 for 6-12 year olds and Table 4 for 13-18 year olds. No "head to head" comparisons fulfilling our inclusion criteria were found.

Table 1. Study Design
StudyTypeCountryGuiding theoretical frameworksSettingChild age (at Baseline)Intervention period
    CareEducationHealth ServiceCommunityHome0-5 years6-12 years13-18 years12 weeks-1 year>1 year-2 years>2 years
Dennison 2004PAUSANR-behaviour changeXX   X  X  
Fitzgibbon 2005Diet & PA combinedUSASCT X   X  X  
Fitzgibbon 2006Diet & PA combinedUSASCT X   X  X  
Harvey-Berino 2003Diet & PA combinedUSANR-behaviour change    XX  X  
Jouret 2009Diet & PA combinedFranceNR-behaviour change theory XX  X   X 
Keller 2009Diet & PA combinedGermanyNR-behaviour change  X XX  X  
Mo-Suwan 1998PAThailandNR-environmental change X   X  X  
Reilly 2006PAScotlandNR-environmental change & behaviouralX    X  X  
Amaro 2006DietItalyNR X    X X  
Baranowski 2003Diet & PA combinedUSASCT and family systems theory   X (summer camp)X X X  
Beech 2003Diet & PA combinedUSASCT and family systems theory   X  X X  
Caballero 2003Diet & PA combinedUSASocial learning theory & principles of American Indian culture and practice X    X   X
Coleman 2005Diet & PA combinedUSANR X    X   X
Donnelly 2009PAUSANR-environmental model X    X   X
Epstein 2001DietUSANR    X X X  
Fernandes 2009DietBrazilLearning through play X    X X  
Foster 2008Diet & PA combinedUSASettings based, CDC guidelines to promote lifelong HE and PA X    X  X 
Gentile 2009Diet & PA combinedUSASocio-ecological theory X XX X X  
Gortmaker 1999aDiet & PA combinedUSASCT X    X  X 
Gutin 2008PAUSAEnvironmental change X    X   X
Hamelink-Basteen 2008Diet & PA combinedNetherlandsNR X    X X  
Harrison 2006PAIrelandSCT X    X X  
James 2004DietUKNR X    X X  
Kain 2004Diet & PA combinedChileNR X    X X  
Kipping 2008Diet & PA combinedUKSCT & behavioural choice X    X X  
Lazaar 2007PAFranceNR X    X X  
Macias-Cervantes 2009PAMexicoNR    X X X  
Marcus 2009Diet & PA combinedSwedenNR X    X   X
Müller 2001Diet & PA combinedGermanyNR X  X X X  
Paineau 2008DietFranceNR X  X X X  
Pangrazi 2003PAMexicoBehavioural X    X X  
Reed 2008PACanadasocio-ecological model X    X X  
Robbins 2006PAUSAThe Health Promotion Model and the Transtheoretical Model X  X X X  
Robinson 2003Diet & PA combinedUSASocial cognitive theory   X  X X  
Rodearmel 2006Diet & PA combinedUSANR    X X X  
Sahota 2001Diet & PA combinedUKMulticomponent health promotion programme, based on the Health Promoting Schools concept X    X X  
Sallis 1993PAUSABehaviour change and self-management X    X  X 
Salmon 2008PAAustraliaSCT and behavioural choice theory X    X X  
Sanigorski 2008Diet & PA combinedAustraliaSocio-ecological model X X  X   X
Sichieri 2009DietBrazilNR X    X X  
Simon 2008PAFranceBehaviour change and socio-ecological model X    X   X
Spiegel 2006Diet & PA combinedUSATheory of reasoned action, constructivism X    X X  
Stolley 1997Diet & PA combinedUSANR   X  X X  
Story 2003aDiet & PA combinedUSASCT, youth development, and resiliency X  X X X  
Taylor 2008Diet & PA combinedNew ZealandNR X    X  X 
Vizcaino 2008PASpainNR X    X X  
Warren 2003Diet & PA combinedEnglandSocial learning theory X  X X  X 
Ebbeling 2006DietUSANR    X  XX  
Haerens 2006Diet & PA combinedBelgiumTheory of planned behaviours & transtheoretical model X     X X 
NeumarkSztainer 2003Diet & PA combinedUSASCT X     XX  
Pate 2005PAUSASocio-ecological model & SCT X     XX  
Patrick 2006Diet & PA combinedUSABehavioural determinants model, SCT & transtheoretical model    X  XX  
Peralta 2009Diet & PA combinedAustraliaSCT X     XX  
Singh 2009Diet and PA combinedNetherlandsIntervention mapping protocol, behaviour change & environmental X     XX  
Webber 2008PAUSASocio-ecological framework X     X  X
TOTALS 2 43 2 6 14 8 39 8 40 7 8
Table 2. Results 0-5 years
  1. BMI: body mass index
    BMIz: standardised body mass index
    CI: confidence interval

Study IDPrimary OutcomesSecondary Outcomes
Dennison 20041. Fatness assessed by repeat measures of height and weight (and calculated BMI) at baseline and after 1 year (end of intervention):
OUTCOME: No differences between intervention and control.
2. Skinfolds:
OUTCOME: No differences between intervention and control.
3. Waist circumference:
OUTCOME: No differences between intervention and control.
4. Television Viewing:
OUTCOME: television viewing was significantly reduced in intervention group on weekdays and Sundays. The percentage of children watching > 2h per day was also significantly decreased in intervention group.
1. Computer games playing:
OUTCOME: No differences between intervention and control.
2. Dietary assessment:
OUTCOME: No significant changes or differences between intervention and control groups in the frequency of snacking whilst watching TV or the number of days family ate dinner together or watched TV during dinner (actual data not reported).
Fitzgibbon 2005

MEASURES: BMI

OUTCOMES: Immediately post-intervention, changes in BMI and BMI z score were not significantly different between intervention and control children.

Intervention children had significantly smaller increases in BMI compared with control children at 1-year follow-up (0.06 vs 0.59 kg/m2; difference -0.53 kg/m2 (95%CI: -0.91 to -0.14), P = 0.01), and at 2-year follow-up (0.54 vs 1.08 kg/m2; difference -0.54 kg/m2 (95% CI: -0.98 to -0.10), P = 0.02), with adjustment for baseline age and BMI.

MEASURES: dietary intake

OUTCOMES: Reported intake of total fat and dietary fibre was similar between children in the control and intervention groups at all assessment points.

Saturated fat intake was significantly lower in intervention children at Year 1 (P = 0.002) but not post-intervention or at Year-2 follow-up.

MEASURES: Physical activity

OUTCOMES: No significant differences between groups in reported frequency and intensity of exercise.

MEASURES: Television viewing

OUTCOMES: No significant differences between groups in TV viewing at any assessment point.

Fitzgibbon 2006

MEASURES: BMI

OUTCOMES: Post-intervention changes in BMI and BMI z score were not significantly different between intervention and control children

MEASURES: dietary intake

OUTCOMES: Reported intake of total and saturated fat and dietary fibre was similar between children in the control and intervention groups at Year 2 follow-up.

MEASURES: Physical activity

OUTCOMES: No significant differences between groups in reported frequency and intensity of exercise.

MEASURES: Television viewing

OUTCOMES: No significant differences between groups in TV viewing at any assessment point.

Harvey-Berino 20031. Maternal fatness assessed by repeat measures of height and weight (and calculated BMI) at baseline and end of pilot:
OUTCOME: No differences between intervention and control.
2. % WHP scores > 85th and 95th percentile:
OUTCOME: No differences between intervention and control.
3. % WHZ scores > 85th and 95th percentile:
1. Diet 3-day food records:
OUTCOME: No differences between intervention and control.

2. Physical activity: CSA accelerometer,
OUTCOME: No differences between intervention and control.
3. Psychological variables: Outcomes Expectations
Self-efficacy
Intentions
Child Feeding Questionnaire
OUTCOME: No differences between intervention and control.
Jouret 2009

MEASURES: Weight, height

OUTCOMES:

Prevalence of overweight (BMI ≥ 90th percentile)

1          At end of study, 12.6% in EPIPOI-1 group was overweight, 11.3% in EPIPOI-2 group, and 17.8% in control (EPIPOI-1 vs control P = 0.02; EPIPOI-2 vs control P =0.003)

2         There was no difference between groups if the schools were not in underprivileged areas, however there was a significant intervention effect in school s in underprivileged areas

At end of study, 12.2% in EPIPOI-1 group was overweight, 17.0% in EPIPOI-2 group, and 36.8% in control (EPIPOI-1 vs control P <0.01; EPIPOI-2 vs control P = 0.001)

BMI z-score

1          At end of study and among schools not in underprivileged areas, median change in BMI z-score in EPIPOI-1 group was +0.39,  +0.22 in EPIPOI-2 group, +0.41 in control (EPIPOI-2 vs control P = 0.01)

3         At end of study and among schools in underprivileged areas, median change in BMI z-score in EPIPOI-1 group was +0.35, +0.50 in EPIPOI-2 group, and +1.35 in control (EPIPOI-1 vs control P < 0.001; EPIPOI-2 vs control P < 0.001)

 
Keller 2009

MEASURES: Height, Weight

OUTCOMES:  This study population stabilized their BMI SDS (P < 0.025).   The children randomised in the intervention group who were not interested to participate, and the children of the control group increased their BMI SDS within the observation period of one year (P < 0.001, P = 0.002).

MEASURES: Diet

OUTCOMES:  According to nutrition diaries a decrease energy intake of the participants of the intervention group was detected. The percentage of protein intake was particularly remarkable, amounting to 363% fulfilment of demand at the beginning of the study and 274% at the end.

 
Mo-Suwan 19981. Fatness assessed by weight, height (BMI, WHCU weight (kg)/height cubed), and triceps skinfold thickness at baseline, twice during intervention and at 29.6 weeks (end of intervention).

OUTCOME: No statistically significant change between intervention and control at 29.6 weeks (end of intervention). The prevalence of obesity, using 95th percentile National Center for Health Statistics triceps skinfold-thickness cutoffs, of both the intervention and control groups decreased. The intervention group decreased from 12.2% at baseline to 8.8% (P = 0.058) and the control group decreased from 11.7% to 9.7% (P = 0.179). A sex difference in the response of BMI to exercise was observed. Girls in the exercise group had a lower likelihood of having an increasing BMI slope than the control girls did (odds ratio: 0.32; 95% CI: 0.18 to 0.56).

Follow-up data on (overall prevalence of obesity, using 95th percentile National Center for Health Statistics triceps-skinfold thickness cut-offs in the control group )

Prevalence of obesity
Baseline Intervention 12.9 Control 12.2
Post-intervention (29.6 wks) Intervention 8.8 Control 9.4
Six months later Intervention 10.2 Control 10.8

Data for follow-up 29.6 wks + 6 months.

School I
Baseline Intervention 16.2 Control 12.5
Post-intervention (29.6 wks) Intervention 8.1 Control 8.3
Six months later Intervention 13.5 Control 8.3.

School II
Baseline Intervention 11.8 Control 12.1
Post-intervention (29.6 wks) Intervention 9.2 Control 9.9
Six months later Intervention Intervention 9.1 Control 12.1.

It is not known (information not available) if the changes at 29.6 weeks plus 6 months are statistically significant . But small changes are unlikely to be clinically significant.
None reported
Reilly 2006

MEASURES: BMI

OUTCOMES: No significant differences between intervention and control groups.

MEASURES: physical activity and sedentary behaviour by accelerometry

OUTCOxMES: No significant differences between intervention and control groups.

MEASURES: fundamental movement skills

OUTCOMES: Children in the intervention group had significantly higher performance in movement skills tests than control children at 6 month follow-up (i.e. immediately post-intervention) after adjustment for sex and baseline performance.

Table 3. Results 6-12 years
Study ID Primary Outcomes Secondary Outcomes
Amaro 2006

MEASURES:  Height, weight

OUTCOMES:  No significant difference in zBMI between treated group and control group at post-assessment controlling for baseline values. Adjusted means were 0.345 (95% CI 0.299 to 0.390) for the intervention group and 0.405 (95% CI 0.345 to 0.465) for the control group. 

MEASURES: Nutrition knowledge

OUTCOMES: Intervention group had significant increase in nutrition knowledge (P < 0.05) compared to control.  Adjusted means were 11.24 (95%CI 10.68 to 11.80) for the intervention group and 9.24 (95% CI 8.50 to 9.98) for the control group.

MEASURES: Dietary Intake

OUTCOMES: Intervention group had significant increase in weekly vegetable intake (P < 0.01) compared with control.  Adjusted mean number of servings per week was 3.7 (95% CI 3.5 to 4.1) for the intervention group and 2.8 (95% CI 2.4 to 3.3) for the control group.

MEASURES: Physical activity

OUTCOMES: No significant difference between groups post-intervention

Baranowski 20031. Fatness assessed by repeat measures of height and weight (and calculated BMI) at baseline and end of pilot:
OUTCOME: No differences between intervention and control.
2. Waist circumference:
OUTCOME: No differences between intervention and control.
3. Dual X-Ray Absorptiometry (DEXA) for % Body fat
OUTCOME: Not reported.

4. Physical activity: CSA accelerometer,
OUTCOME: No differences between I and C.
5. a modification of the Self-Administered Physical Activity Checklist (SAPAC),
OUTCOME: No differences between intervention and control.
6. GEMS Activity Questionnaire (GAQ) computerised
OUTCOME: No differences between intervention and control.

7. Dietary intake measured by two 24 hour recalls using Nutrition Data System computer programme (NDS-R).
OUTCOME: No differences between intervention and control.
1. Participation in summer camp
OUTCOME: I: 91.5% and C: 80.5%
2. Monitoring website usage (log-on rates).
OUTCOME: Intervention: child mean 48%, parent mean 47%; Control: child mean 25%, parent mean 16%.
Beech 20031. Fatness assessed by repeat measures of height and weight (and calculated BMI) at baseline and end of pilot:
OUTCOME: No differences between intervention and control.
2. Waist circumference:
OUTCOME: No differences between intervention and control.
3. Dual X-Ray Absorptiometry (DEXA) for % Body fat
OUTCOME: Not reported.

4. Physical activity: accelerometer CSA,
OUTCOME: No differences between intervention and control.
5. a modification of the Self-Administered Physical Activity Checklist (SAPAC),
OUTCOME: Not reported.
6. GEMS Activity Questionnaire(GAQ) computerised
OUTCOME: No differences between intervention and control.

7. Dietary intake measured by two 24 hour recalls using Nutrition Data System computer programme (NDS-R).
OUTCOME: Intervention parent group significantly lower for sweetened drinks compared with intervention child group and controls.
1. Psychological variables:
Body silhouettes McKnight Risk Factor Survey, and Stunkard et al. 1983.
OUTCOME: No differences between intervention and control
2. Over concern with weight or shape:
OUTCOME: Intervention significantly better than control.
3. Parental food preparation practices
OUTCOME: Intervention significantly better than control.
4. Self-Perception Profile for Children
OUTCOME: No differences between intervention and control
5. Healthy Growth Study for physical activity expectations, and a self-efficacy measure.
OUTCOME: No differences between intervention and control.
Caballero 20031. Fatness assessed by repeat measures of height and weight (and calculated BMI), at baseline and after 3 years (end of intervention):
OUTCOME: No differences between intervention and control
2. Triceps and subscapular Skinfolds.
OUTCOME: No differences between intervention and control
3. Bioelectrical impedance.
OUTCOME: No differences between intervention and control.
1. Lunch Programme:
OUTCOME: Intervention school's lunches had significantly less energy from fat (4%), P = 0.005. 24 hour dietary records showed significant reduction in energy P = 0.003 and total fat P = 0.001.
2. Physical Activity
OUTCOME: Tri Trac R3D accelerometer showed no significant differences, but trends were in the desired direction. 24 hour recalls were significantly higher in I P = 0.001.
3. Knowledge, attitudes and beliefs:
OUTCOME: significant improvements were found in I, especially in the 3rd grade (8-9 years), but Self efficacy to be physically active was higher in I schools but choosing healthy foods was not.
4. Family Programme
OUTCOME: families attending events was 58%.
Coleman 2005

MEASURE: Risk of overweight and overweight

OUTCOME: The rate of increase in the percentage of students at risk of overweight or overweight from 3rd to 5th grades was 13% in control girls compared with 2% in intervention girls and 9% in control boys compared with 1% in intervention boys.

MEASURE: Anthropometry

OUTCOME: No effect of intervention on height, weight, waist-to-hip ratio or BMI. All children had increases in these measures from year to year.

MEASURE: Aerobic fitness

OUTCOME: Results for passing Fitnessgram standards were similar between intervention and control schools for the 3rd grade. In the 4th grade, control schools had higher rates than intervention schools, while in the 5th grade, intervention schools had higher rates than control schools.

MEASURE: PE outcomes

OUTCOME: For part of the 3rd and 4th grades, intervention schools had higher MVPA than control schools. By the end of the 4th grade, control schools had reached similar values to intervention schools, with a similar pattern for the 5th grade.

Intervention schools has higher vigorous physical activity (VPA) than control schools in the fall of 4th grade and for both 5th grade semesters.

MEASURE: Cafeteria outcomes

OUTCOME: At the beginning and end of the 4th grade, intervention schools had a lower percentage of fat than control schools. This difference disappeared by the 5th grade. Intervention schools met programme goals for fat content in school lunches during the 2nd year of the programme, while control schools did not at any time.

No schools reached programme sodium recommendations.

Donnelly 2009

MEASURES: BMI

OUTCOMES: No significant differences for change in BMI or BMI percentile (baseline to 3 year) for intervention vs control (not influenced by gender).

Schools (n = 9) with ≥ 75min of PAAC/wk showed significantly less increase in BMI at 3 years compared to schools (n = 5) with < 75min (1.8 ± 1.8 vs  2.4 ± 2.0; P = 0.02)

MEASURES: Daily PA (accelerometer)

OUTCOMES: Over a 4-day average (consecutive), children in PAAC schools had greater levels of PA (13%>) compared to children in control schools (P = 0.007).

Children in PAAC schools had greater levels of PA during the school day (12%>; 0.01) and on weekends (17%>; 0.001) compared with children in control schools.

Children in PAAC schools exhibited 27% higher levels of moderate to vigorous intensity PA (?4 METS) compared with children in control schools (P = 0.001).

MEASURES: Academic achievement measured using Weschler Individual Achievement Test 2nd edition.

OUTCOMES: significant improvement in academic achievement from baseline to 3 years were observed in the PAAC compared with the control schools for the composite, reading, math and spelling scores (all P < 0.01)

Epstein 20011. Fatness assessed by percentage of overweight (established by comparing the BMI of the subject with the relevant 50th BMI percentile based on the gender and age of the subject) at baseline and at one year (end of intervention).
OUTCOME: Children showed no significant differences in percentage of overweight with either intervention: increase fruit and vegetable intervention (-1.10 + 5.29) or decrease high fat/high sugar intervention (-2.40 + 5.39).

2. Dietary intake:
OUTCOME: High fat/high sugar intake significantly decreased across all children independent of group. Children also showed trends toward greater increases in fruit and vegetable intake for the Increase Fruit and Vegetable group through the one year study.
 
Fernandes 2009

MEASURES: Nutritional status defined on the basis of BMI for age and sex.

OUTCOMES: No significant changes from baseline in the prevalence of overweight/obesity (BMI?85th percentile) were observed in either group (both p=1.0) with no difference between groups. The percentage of overweight/obese children increased from 21.8 to 23.6% in the intervention group and from 33.7 to 35.0% in the no-intervention group (P > 0.05).

MEASURES: Frequency of eating foods (either 0-1 day or 2-3 days) prohibited by School Canteens Act by self-report for two 3-day dietary recalls

OUTCOMES: The percentage of children who ate foods prohibited by the Act on 2-3 days decreased in both intervention and control groups (not significant)

MEASURES: Distribution of children eating certain foods on the two 3-day dietary recalls

OUTCOMES: In the control group, the percentage eating mass-produced snacks increased (P = 0.008), while in the intervention group, this decreased (p=0.016).

In both groups, there was a significant reduction in the intake of artificial juice (P < 0.001) and chocolate (I: P < 0.001; C: P = 0.031).

There was an increase in the percentage of children drinking soda in both intervention and control groups (P = 0.002 and P = 0.016).

For the percentage of children eating yoghurt, there was an increase in the intervention group (P = 0.016) and a decrease in the control group (P = 0.016).

There was a decrease in the percentage of children drinking natural juice in the control group (P < 0.001) and a numerical increase in the intervention group (P = 0.063).

There was an increase in the percentage of children eating fruit in both groups, but this was only significant in the control group (P = 0.016 vs P = 0.25).

Foster 2008

MEASURES: Incidence of overweight and obesity

OUTCOMES: Fewer children in the intervention schools (7.5% [unadjusted mean]) than in the control schools (14.9% [unadjusted mean]) became overweight after 2 years (adjusted odds ratio: 0.67 [0.47 to 0.96]; P = 0.03 [adjusted for gender, race/ethnicity and age]).

No differences between control and intervention groups in the incidence of obesity at 2 years (P = 0.99).

The predicted odds of incidence of either overweight or obesity were 15% lower for the intervention group (odds ratio: 0.85 [0.74 to 0.99]; P <0.05)

MEASURES: Prevalence and remission of overweight and obesity

OUTCOMES: After 2 years, the predicted odds of overweight prevalence were 35% lower for in the intervention group (odds ratio: 0.65 [0.54 to 0.79]; P < 0.0001 [adjusted for gender, race/ethnicity, age]).

Effect was slightly greater in black students who, if receiving the intervention, were 41% less likely to be overweight than those in control schools after 2 years (after controlling for gender, age and baseline prevalence).

No differences between intervention and control groups in the prevalence of obesity after 2 years (P = 0.48).

No difference between intervention and control groups for combined prevalence of overweight and obesity (P = 0.07).

No differences between groups with respect to the remission of overweight or obese after 2 years.

MEASURES: Dietary intake and physical activity sedentary behaviours, potential adverse effects

OUTCOMES: Reported decreases in both intervention and control schools in self-reported consumption of energy, fat, and fruits and vegetables over 2 years with no differences between groups.

Decreases in self-reported amounts of physical activity in both intervention and control groups with no differences between groups.

MEASURES: Sedentary behaviours

OUTCOMES: Inactivity was 4% lower after 2 years in the intervention group compared with the control group after adjusting for gender, age, race/ethnicity and baseline inactivity (odds ratio: 0.96 [0.94 to 0.99]; P < 0.01).

Weekday television watching was 5% lower in the intervention group than in the control group (odds ratio: 0.95 [0.93 to 0.97]; P < 0.0001) after 2 years.

MEASURES: Potential adverse effects

OUTCOMES: The intervention showed no evidence of an adverse impact with respect to a worsening body image or changes in incidence, prevalence and remission of underweight.

Gentile 2009

MEASURES: Height and Weight

OUTCOMES: No significant difference in BMI between groups post-intervention or at 6 months follow-up

MEASURES: Screen time

OUTCOMES: Child report (hours/week):  No significant difference between groups post-intervention or at 6 months follow-up

Parent report (hours/week)  Significantly lower in intervention group post-intervention  (I: 22.8(0.7), C: 24.6(0.3), P <0.05) and at 6 months follow-up (I: 23.7(0.5), C: 25.7(0.5), P <0.05) ) compared with control group

MEASURES: Fruit and vegetable consumption

OUTCOMES: Child report (servings/week):  Significantly lower in intervention group post-intervention  (I: 4.4(0.2), C: 4.2(0.1), P < 0.05) and at 6 months follow-up (I: 4.1(0.2), C: 4.0(0.1), P < 0.05) compared with control group

Parent report (servings/week)  Significantly lower in intervention group post-intervention  (I: 24.9(0.7), C: 22.6(0.4), P < 0.05) and at 6 months follow-up (I: 22.5(0.7), C: 21.3(0.3), P < 0.05) ) compared with control group

MEASURES: Physical activity (steps/day)

OUTCOMES:  No significant difference on pedometer measures of physical activity

 
Gortmaker 1999a

1. Fatness assessed by repeat measures of height, weight, (and calculated BMI), and triceps skinfold thickness, at baseline and after 18 months (end of intervention) :
OUTCOME: The prevalence of obesity among girls in intervention schools was reduced compared with controls, controlling for baseline obesity (odds ratio, 0.47; 95% confidence interval, 0.24-0.93; P = 0.03), with no differences found among boys. There was greater remission of obesity among intervention girls vs control girls (odds ratio, 2.16; 95% confidence interval, 1.07-4.35; P = 0.04).

Reestimated regressions that excluded observations with missing data and got similar results with both approaches.

1. Television viewing time:
OUTCOME: Both girls and boys in the intervention group spent less time viewing television.
2. Dietary intake:
OUTCOME: Intervention girls reported eating more fruit and vegetables and reduced their increase in dietary energy over the two years of the intervention.

Behavioural variables as explanations for intervention effect: Regression indicated that only change in television viewing mediated the intervention effect.

Gutin 2008

(see Notes in Included Studies table)

MEASURES: Percent body fat (%BF)

OUTCOMES:

1 year: %BF decreased in intervention participants with no change in control participants (adjusted change: -0.76 [-1.42, -0.09]; P = 0.027). No significant differences between groups for ITT analysis.

Significant relationship between level of programme attendance and change in %BF in intervention group, with greater decreases in %BF observed with higher programme attendance (P = 0.0004).

3 year: Significant group by time interaction (P < 0.05). Intervention group reduced their body fat during school months and this returned to levels similar to those of the control group after the summer months (school vacation).

MEASURES: Bone Mineral Density (BMD)

OUTCOMES:

1 year: Compared with control, intervention participants showed significantly greater gains in BMD (adjusted change: 0.008 [0.001, 0.015]; P = 0.023).

In intervention group greater increases in BMD were observed with higher programme attendance (P = 0.029).

3 year: Significant group by time interaction in favour of intervention participants (P < 0.01).

MEASURES: Fat mass

OUTCOMES:

1 year: No significant differences between groups post-intervention.

In intervention group greater decreases in fat mass were observed with higher programme attendance (P = 0.0004).

3 year:  No significant differences between groups post-intervention (data not reported).

MEASURES: Fat-free soft tissue (FFST)

OUTCOMES:

1 year: No significant differences between groups post-intervention.

3 year: Significant group by time interaction in favour of intervention participants (P < 0.01).

MEASURES: cardiovascular fitness (CVF)

OUTCOMES:

1 year: Compared with control, intervention participants showed significantly greater gains in CVF (adjusted change: -4.4 [-8.2 to -0.6]; P = 0.025).

In intervention group greater increases in CVF were observed with higher programme attendance (P = 0.029).

3 year: Significant group by time interactions in favour of intervention participants (P < 0.01). The intervention group improved in fitness during school months and this returned to levels similar to those of the control group after the summer months.

MEASURES: BMI

OUTCOMES:

1 year: No significant differences between groups post-intervention.

3 year: Significant group by time interaction, with the increase in BMI being greater in the intervention group than in the control group (P < 0.05).

MEASURES: waist circumference

OUTCOMES:

1 year: No significant differences between groups post-intervention.

MEASURES: CV risk factors

OUTCOMES:

1 year: No significant differences between groups post-intervention.

Hamelink-Basteen 2008

MEASURES: Height, weight

OUTCOMES: BMI increase did not differ between groups post-intervention

MEASURES: Obesity

OUTCOMES: Prevalence of obesity did not differ between groups post-intervention

MEASURES: Nutrition knowledge

OUTCOMES:  Higher level of knowledge about importance of vegetables and fruit and a healthy diet

MEASURES: Lifestyle and behaviours

OUTCOMES: Intervention group walked more frequently to school, watched less television, drank less soft drinks and ate less sweets than control group.

Harrison 2006

MEASURES: Height, weight

OUTCOMES: No significant difference between groups post-intervention

MEASURES:  Physical activity

OUTCOMES: MVPA in 30 min blocks was significantly higher (by 0.84 blocks; 95%CI 0.11, 1.57) in the intervention group post-intervention (P = 0.03)

MEASURES: Screen time

OUTCOMES: No significant difference between groups post-intervention

MEASURES: Physical activity self-efficacy

OUTCOMES: Significantly higher self efficacy (by 0.86 units; 95%CI: 0.16, 1.56) post-intervention (P = 0.03)

MEASURES: Aerobic fitness (20m shuttle test)

OUTCOMES:  No significant difference between groups post-intervention

 
James 2004

MEASURE: BMI at 1 year (end of intervention) and 3 years post-baseline (or 2-year follow-up)
OUTCOME: No differences between intervention and control in the change in BMI from baseline

MEASURE: Proportion of children overweight or obese at 1 year (end of intervention) and 3 years post-baseline (or 2-year follow-up), based on proportion above 91st centile
OUTCOME: At 1 year, the mean percentage of overweight and obese children increased in the control clusters by 7.5%, compared with a decrease in the intervention group of 0.2% (mean difference 7.7%, 95%CI: 2.2% to 13.1%). At 3 years, this difference was smaller and no longer significant (Odds ratio: 0.79 (95%CI: 0.52 to 1.21)).

MEASURE: Carbonated drink consumption at 1 year (end of intervention):
OUTCOME: Children in intervention classes reported fewer carbonated drinks (0.6 glasses fewer compared with an increase in controls of 0.2 (95% CI: 0.1 to 1.3).
MEASURE: Water consumption at 1 year (end of intervention)
OUTCOME: No differences between intervention and control.
Kain 2004Fatness assessed by repeat measures of height and weight (and calculated BMI) at baseline and after 1 year (end of intervention):
OUTCOME: No differences between intervention and control.
Skinfolds:
OUTCOME: No differences between intervention and control.
Waist circumference:
OUTCOME: decreased significantly in intervention group by a mean of 0.9cm and increased in controls by same amount.
Physical Fitness:
OUTCOME: Shuttle run test and lower back flexibility both improved for boys and girls in the intervention group compared with controls.
1. Dietary assessment: food frequency questionnaire of 16 key items:
OUTCOME: Not reported.
2. Attitudes and behaviours (14 questions about physical activity and some about fruit and vegetable consumption):
OUTCOME: Not reported.
Kipping 2008

MEASURES: Time spent doing screen-based  activities

OUTCOMES: No statistically significant differences between intervention and control groups.

MEASURES: BMI

OUTCOMES:  No statistically significant differences between intervention and control groups.

MEASURES: Obesity (BMI > 95th percentile)

OUTCOMES:  No statistically significant differences between intervention and control groups. However, subgroup analysis by gender showed that the odds of being overweight post-intervention were higher in females (1.52; 95%CI: 0.37 to 6.25) than males (0.28; 95% CI: 0.06 to 1.33)

MEASURES: Walks/cycles to and from school

OUTCOMES:  No statistically significant differences between intervention and control groups.

Lazaar 2007

MEASURES: Obesity status

OUTCOMES: A larger proportion of obese children (BMI > 97th percentile) became overweight (90th <BMI <97th percentile) in the intervention group compared with control (16.3%, P < 0.05 versus 9.3%, P < 0.05).

The proportion of non obese children becoming obese or overweight was greater in controls than in the intervention group (14.8%, P < 0.05 versus 2.6%, P= ns)

MEASURES

OUTCOMES

MEASURES: BMI

OUTCOMES: Average BMI remained unchanged over time in both groups overall.

In girls, there was a significant group*time interaction (P < 0.01) and a significant effect of PA intervention between intervention and control in obese (-1.4% vs 0.9%; P < 0.05) and non obese (-0.2% vs 2.1%; P < 0.001) girls.

MEASURES: BMI z-score

OUTCOMES: In boys, BMI z-score declined significantly over time only in the intervention group and was significantly different compared with controls (P < 0.001). In boys, there was also a significant difference between intervention and control groups in both obese (-2.8% vs 1.5%; P < 0.05) and non obese boys (-2.4% vs 2.6%; P < 0.01).

In girls, BMI z-score declined significantly in all groups except for obese controls. The decrease was higher in the intervention groups compared with control groups for both obese (-6.8% vs -2.4%; P < 0.001) and non obese (-3.1% vs -1.8%; P < 0.01) girls. Changes were greater in obese compared with non obese girls (P < 0.001).

MEASURES: Waist circumference

OUTCOMES: In girls, waist circumference was affected over time, decreasing in the intervention group and increasing in the control group (-3.3% vs 2.8%; P < 0.001).

In boys, waist circumference was not significantly affected over time.

MEASURES: Skinfold thickness

OUTCOMES: In girls, the sum of skinfolds was significantly decreased over time in the intervention groups in both obese (-4.4%, P < 0.05) and non obese (-3.2%, P < 0.001) girls, with a significant difference between obese and non obese girls (P < 0.05) and no significant changes in controls.

In boys, the sum of skinfolds was not significantly altered over time.

MEASURES: Fat-free mass

OUTCOMES: In girls, fat-free mass increased over time, with greater increases in intervention children compared with controls for both obese (5.2% vs 2.4%, P < 0.001) and non obese (4.0% vs 0.6%, P < 0.05) girls.

In boys, fat-free mass improved over time with higher changes in the intervention groups (obese = 6.4%, P < 0.001 and non obese = 3.4%, P < 0.001) compared with control groups (obese = 1.3%, P = ns and non obese = 0.7%, P = ns), and a higher increases in obese boys compared with non obese boys (P < 0.01)

Macias-Cervantes 2009

MEASURES: Anthropometric measurements: height, weight, BMI, waist circumference, triceps skinfold

OUTCOMES: Differences between groups post-intervention were not tested

MEASURES: Glucose, triglycerides, cholesterol, HDL-C, LDL-C, HOMA-IR

OUTCOMES: Intervention group decreased insulin (P < 0.001) and HOMA index (4.36 vs. 2.39, P <0.001) from baseline to follow-up, but no difference in control group. No other differences were reported.   Differences between groups post-intervention were not tested

 

MEASURES: Physical activity (steps/day, by pedometer)

OUTCOMES:  Intervention group increased their median daily steps from baseline to follow-up (15,329 to 19,910). Differences between groups post-intervention were not tested

MEASURES: Food intake

OUTCOMES: Not reported

Marcus 2009

MEASURES: Height and weight

OUTCOMES: Prevalence of overweight/obesity decreased by 3.2% (from 20.3 to 17.1) in intervention schools compared with an increase of 2.8% (from 16.1 to 18.9) in control schools (P < 0.05).

No difference between intervention and control groups in change in zBMI (BMIsds) post-intervention

A larger proportion of the children who were initially overweight reached normal weight in the intervention group (14%) compared with the control group (7.5%), P < 0.017

MEASURES: Physical activity measured by accelerometry

OUTCOMES: No significant differences between groups post-intervention

MEASUREs: Eating habits at home measured by parental report.

OUTCOMES: Post-intervention eating habits at home were healthier among intervention families.   Significant differences between children in intervention and control schools were found for high-fat dairy products (P < 0.001), sweetened cereals (P<0.02) and sweet products (P < 0.002).

MEASURES: Eating disorders measured by self-report.

OUTCOMES: No significant differences between groups post-intervention

Müller 20011. Fatness assessed by repeat measures of height and weight.
OUTCOME: No significant difference between I and C from BMI data available at baseline and 1 year. The median of the BMI was 15.2 (intervention school) and 15.4 for children in control schools. At one-year follow-up the corresponding data were 16.1 and 16.3 respectively.

2. Triceps skinfold thickness
OUTCOME: Significant difference in favour of the intervention group at one-year follow-up (age-dependent increases in median triceps skinfolds of the whole group (from 10.9 to 11.3mm in ‘intervention schools’ vs from 10.7 to 13.0mm in ‘control schools’, P < 0.01).  Also positive intervention impacts on percentage fat mass of overweight children (increase by 3.6 vs 0.4% per year without and with intervention, respectively; P < 0.05).
1. Nutrition knowledge
OUTCOME: significant increase from 48% to 60% of the children.
2. Daily physical activities
OUTCOME: significant increase from 58 to 65% of the children.
3. Daily fruit and vegetable consumption
OUTCOME: significant increase from 40 to 60% of the children.
4. Daily intake of low fat food
OUTCOME: significant increase in frequency of daily intake of low fat food from 20 to 50%.
5. Decrease in TV watching
OUTCOME: significant decrease from 1.9 to 1.6 h/day.
Paineau 2008

MEASURES: Nutritional intake

OUTCOMES: Compared with controls, participants in the intervention groups achieved their nutritional targets for fat intake and for sugar and complex carbohydrate intake, leading to a decrease in energy intake (children, P<0.001; parents, P = 0.02).

MEASURES: height and weight

OUTCOMES:  No significant differences were found between groups in BMI or zBMI, with  a trend toward negative changes in zBMI in all 3 groups.

BMI differed in parents (group A, +0.13, 95% CI, ?0.01, 0.27; group B, ?0.02, 95% CI, ?0.14, 0.11; control group,+ 0.24, 95% CI, 0.13, 0.34; P =.001), with a significant difference between group B and the control group (P = 0.01)

MEASURES:  Physical activity

OUTCOMES:  In children, changes in physical activity throughout the study did not differ between groups, either for daily screen viewing or for activities in clubs

MEASURES: Food-related quality of life

OUTCOMES:  In parents, food-related quality of life did not change differently between groups throughout the study

Pangrazi 20031. Fatness assessed by repeat measures of height and weight (and calculated BMI) at baseline and end of pilot:
OUTCOME: No differences between intervention and control.

2. Physical activity: accelerometer CSA,
OUTCOME: All students: PLAY & PE, and PLAY only groups were significantly more active than C. Girls: PLAY & PE, and PE only groups were significantly more active than controls.
None reported.
Reed 2008

MEASURES:  Cardiovascular fitness (measured by 20-m shuttle run test)

OUTCOMES:  The intervention group demonstrated a significantly greater increase (20%)  in fitness (20-m shuttle run) compared with the control group (P <0.05).

MEASURES: Blood pressure (systolic and diastolic)

OUTCOMES: Systolic blood pressure in the intervention group decreased significantly compared with an increase in the control group (5.7% smaller increase; P < 0.05). There was no difference for change in diastolic blood pressure.

MEASURES: Total cholesterol, HDL, LDL, Apo B, C-reactive protein and fibrinogen

OUTCOMES: Although all serum variables in the intervention group decreased more than these same variables for the control group changes failed to reach significance

MEASURES: Weight, height

OUTCOMES: BMI not different between groups post-intervention

Robbins 2006

MEASURES:  Physical activity variables (frequency, intensity, duration, and  readiness)

OUTCOMES: No significant differences between groups

MEASURES: Physical activity determinants (interpersonal influences, physical activity enjoyment, self efficacy, and perceived benefits and barriers of physical activity)

OUTCOMES:  The intervention group had significantly greater social support across time (P = 0.019).  No other significant differences between groups.

No other significant differences between groups

 
Robinson 20031. Fatness assessed by repeat measures of height and weight (and calculated BMI) at baseline and end of pilot:
OUTCOME: No differences between intervention and control.
2. Waist circumference:
OUTCOME: No differences between intervention and control.
3. Dual X-Ray Absorptiometry (DEXA) for % Body fat
OUTCOME: Not done

4. Physical activity: accelerometer CSA,
OUTCOME: No differences between intervention and control.
5. a modification of the Self-Administered Physical Activity Checklist (SAPAC):
OUTCOME: No differences between intervention and control.

6. GEMS Activity Questionnaire(GAQ) computerised
OUTCOME: Not reported

7. Dietary intake measured by two 24 hour recalls using Nutrition Data System computer programme (NDS-R).
OUTCOME: No differences between intervention and control.
1. TV usage: TV, videotape and video games:
OUTCOME: No differences between intervention and control.
2. Total household TV usage:
OUTCOME: Intervention significantly less than control.
3. Ate breakfast with TV on:
OUTCOME: No differences between intervention and control.
4. Ate dinner with TV on:
OUTCOME: Intervention significantly less than control.

5. Over concern with weight or shape:
OUTCOME: Intervention significantly better than control.
Rodearmel 2006

MEASURES: Steps per day

OUTCOMES: Steps per day increased in all members of intervention families but not in any members of the control families. Intervention target girls/boys, mums and dads, all took significantly more steps per day on average than their control counterparts (P < 0.05).

Increases in steps/day over baseline in intervention groups approached the primary goal of the intervention (an additional 2000 steps/day)

MEASURES: cereal consumption

OUTCOMES: Intervention families consumed approximately 1 serving of cereal/day, double the amount consumed by control families (P < 0.05)

MEASURES: Food Intake

OUTCOMES: No significant changes in self-reported total energy intake or in intake of any macronutrient in either group.

MEASURES: Body weight/adiposity

OUTCOMES: Significant between-group differences (P < 0.05) were found pre- to post-study in the difference in the mean change of all body weight/adiposity measures of primary importance for overweight target children (%BMI-for-age, % body fat) and their parents (weight, BMI and % body fat). All trends were in favour of the intervention group.

When analysed by gender, significant between-group differences were found in the difference in the mean change of both the child- and adult-specific body weight/adiposity measures between intervention and control for target girls and mums, but not for target boys and dads.

 
Sahota 2001

1. Fatness assessed by repeat measures of height and weight (and calculated BMI) at baseline and after 1 year (end of intervention)

OUTCOME: No differences between groups overall (weighted mean difference between intervention and control of 0 (95% CI: -0.1 to 0.1) overall, or when analysed by weight status for overweight (WMD: -0.07, 95% CI -0.22 to 0.08) or obese (WMD: -0.05; 95% CI: -0.22 to 0.11) children separately.

2. Dietary intake:

OUTCOME: Vegetable consumption by 24 hour recall was higher in children in the intervention group than the control group (weighted mean difference 0.3 portions/day, 95% CI 0.2 to 0.4). Fruit consumption was lower in obese children in the intervention group ( - 1.0, - 1.8 to - 0.2) than those in the control group. The three-day diary showed higher consumption of high sugar foods (0.8, 0.1 to 1.6)) among overweight children in the intervention group than the control
group.

3. Physical activity:

OUTCOME: Sedentary behaviour was higher in overweight children in the intervention group (0.3, 0.0 to 0.7).

4. Psychological measures:

OUTCOME: small increase in global self-worth for obese children in the intervention schools.

1. Nutrition knowledge:OUTCOME: Focus groups indicated higher levels of self-reported behaviour change, understanding and knowledge.
Sallis 19931. Fatness assessed by weight, height, BMI, calf and triceps skinfold at baseline and 6, 12, 18 months.
OUTCOME: Little difference in BMI for boys and girls between specialist and teacher led intervention conditions (statistical significance not addressed) at 6, 12 and 18 months.
Small differences in BMI for boys and girls between specialist-led, teacher-led conditions and usual physical education control. (statistical significance not addressed) at 6, 12 and 18 months.
None reported
Salmon 2008

MEASURES: BMI

OUTCOMES: Significant reduction in BMI post-intervention in the BM/FMS group compared with control (average -1.88 BMI units less than control; P < 0.01). This was maintained at 6 and 12 month follow-up.

MEASURES: Weight status

OUTCOMES: On average, those in the BM/FMS group were over 60% less likely to be overweight or obese compared with control (P < 0.05). This was maintained at 6 and 12 month follow-up.

MEASURES: Physical activity (accelerometer)

OUTCOMES: Compared with controls, FMS group children recorded higher levels and greater enjoyment of PA; and BM children
recorded higher levels of PA across all four time points.Significant average effects over time in favour of the BM and FMS groups compared with control (P < 0.05). This was maintained at 6 and 12 month follow-up. Gender was a significant moderator, with boys showing greater increases.

MEASURES: Self-reported screen behaviours

OUTCOMES: Children in the BM group reported 229 min/week more in TV viewing on overage over time compared with control (P < 0.05). These effects were maintained with inclusion of 6 and 12 month follow-up data.

MEASURES: Self-reported enjoyment of physical activity (five-point Likert scale)

OUTCOMES: Children in the FMS group reported higher average enjoyment scores over time compared with those in the control group (P < 0.05).

MEASURES: Mastery of fundamental movement skills

OUTCOMES: No significant intervention effects on FMS z-scores between baseline and any of the post-intervention time points. In girls, there was a significant effect, with those in the BM (P < 0.05) and FMS (P < 0.01) groups recording higher average FMS z-scores compared with those in the control group.

MEASURES: Body Image (five-point Likert scale)

OUTCOMES: No effects on children’s happiness with their body shape and body weight, or eating to gain weight or lose weight in the last month. When stratified by gender, boys in the FMS group (P = 0.003) and BM/FMS group (P = 0.014) recorded significantly higher satisfaction with their body shape between baseline and all post-intervention time points compared with control.

Sanigorski 2008

MEASURES: Body weight

OUTCOMES: Children in intervention population gained less weight than in the comparison population (-0.92kg [-1.74 to -0.11], P = 0.03).

MEASURES: Waist circumference

OUTCOMES: Children in intervention population showed lower increases in waist circumference than in the comparison population (-3.14cm [-5.07 to -1.22], P = 0.01).

MEASURES: BMI-z score

OUTCOMES: Children in intervention population showed lower increases in BMI-z score than in the comparison population (-0.11 [-0.21 to -0.01], P = 0.04).

MEASURES: Relationship between baseline indicators of children’s household SES and changes in children’s anthropometry.

OUTCOMES: In the comparison population, lower SES was associated with a greater weight gain (statistically significant relationship in 19 of 20 analyses).

In the intervention population, no statistically significant relationships were observed.

MEASURES: BMI

OUTCOMES: No significant difference between intervention and comparison populations (P = 0.20).

MEASURES: waist/height ratio

OUTCOMES: Children in intervention population showed lower increases in waist/height ratio than in the comparison population (-0.02 [-0.03, -0.004], P = 0.01).

MEASURES: Prevalence and incidence of ow/ob

OUTCOMES: Prevalence of overweight/obesity increased in both groups, and the incidence of overweight/obesity was not significantly different between groups.

Sichieri 2009

MEASURES: change in BMI

OUTCOMES: BMI and weight increased in both groups with no statistically significant differences between groups. Among students overweight at baseline, the intervention group showed greater BMI reduction and this difference was statistically significant among girls (P = 0.009).

MEASURES: carbonated SSB and juice intake

OUTCOMES: Mean intake of sodas per class was reduced in both groups, with reduction being about four times greater in the intervention compared with the control group (-69ml vs -13ml). Carbonated beverage intake was significantly reduced in the intervention group compared with the control group (p=0.03), but fruit juice consumption was slightly increased in the intervention group (P = 0.08).

MEASURES: overweight and obesity

OUTCOMES: For both groups, obesity changed from about 4 to 4.5% with no statistically significant difference between groups.

Simon 2008

MEASURES: BMI

OUTCOMES: intervention students showed a lower increase in BMI (P = 0.01) over time than control students. The differences across groups of the adjusted (by baseline weight status) BMI changes were -0.33 (-0.55 to -0.12) at 3 years and -0.36 (-0.60 to -0.11) at 4 years.

Cumulative incidence of overweight was lower in the intervention group than in the control group (4.2% vs  9.8% at 4 years; P < 0.01).

Sensitvity analyses conducted using intention to treat population to compare this with analysis using data from only those participants who completed the study and similar results were observed.

MEASURES: Self-reported leisure physical activity

OUTCOMES:  At 4 years, 79% of intervention students practised at least one supervised physical activity outside school PE classes, compared with 47% of control students (P < 0.001). Supervised leisure physical activity increased in intervention students, whereas it slightly decreased in controls, with a difference across groups of the 4-year within-group changes of 66min (95%CI: 34 to 98) per week (P < 0.0001).

MEASURES: TV/video viewing time

OUTCOMES: Intervention students had a greater reduction over time of TV/video viewing than controls (P < 0.01), with a difference in the 4-year changes of -16min (95%CI: -29, -2) per day.

MEASURES: Active commuting to/from school

OUTCOMES: Slight increase in active commuting observed across both groups.

MEASURES: Self-efficacy and intention towards physical activity

OUTCOMES: Intervention associated with an increase of self-efficacy during the first 2 years (P < 0.0001 and 0.01 at 1 and 2 years respectively) and a sustained improvement of intention toward physical activity (P < 0.05).

MEASURES: Cardiovascular risk factors

OUTCOMES: Compared with controls, intervention participants had a higher increase of high-density lipoprotein-cholesterol concentration at 4 years and a slight decrease in blood pressure at 2 years. Other biological cardiovascular risk factors were similar between groups over time.

Spiegel 2006

MEASURES: Height, weight

OUTCOMES:  There were significant shifts in BMI in the intervention group, with a 2% reduction in overweight (BMI > 85% for age and sex) in the intervention group.  There was a significant correlation at the 0.01 level between the intervention and a reduced BMI and BMI-for-age data showed that 39.4% of the comparison group and 36.4% of the intervention group were either overweight or at risk for overweight when measured at the baseline interval.

Significant shifts in BMI were noted in the intervention group, with a 2% reduction in overweight (BMI _ 85% for age and sex) youth in the intervention group. Student’s t test and Pearson correlations were used to evaluate the significance of the BMI shift. Both analyses showed a significant correlation at the 0.01 level between the intervention and a reduced BMI. Student’s t test mean for the comparison group was 0.5210 (N _ 479; SD _ 1.01610, SE _ 0.04643) and for the intervention group was 0.1606 (N _ 534, SD _ 0.89446, SE _ 0.03871). The Pearson correlation for change in BMI baseline to post-data measure with treatment (r _ _0.186; N _ 1013) was significant at the 0.01 level (two-tailed).

BMI-for-age data showed that 39.4% of the comparison group and 36.4% of the intervention group were either overweight or at risk for overweight when measured at the baseline interval. There was no significant shift in the comparison group, but there was a notable reduction in the intervention group in overweight and at risk for overweight classification, which was most significant at the at risk for overweight (BMI-for-age between 85% to 95%) level.  There was a 16.2% attrition rate in the comparison group (N _ 479 matched measures between baseline to post-data) and a 13.7% attrition rate in the intervention group (N _ 534 matched).

There was no significant shift in the comparison group, but there was a reduction in the intervention group in overweight and at risk for overweight classification, which was most significant at the ‘at risk for overweight’ (BMI-for-age between 85% to 95%) level.

MEASURES:  Fruits and Vegetable Consumption

OUTCOMES:  Post-intervention, there was an increase in fruit and vegetable consumption

in both groups from baseline levels, with a higher increase in the intervention group.

 

MEASURES: Physical activity levels

OUTCOMES: Physical activity levels in the intervention group increased in both school and home settings.  Post-intervention, intervention students reported an average of 102.5 min/wk of physical activity during the school day (up from 59min/wk at baseline) and a mean level of 37.42 min/d outside of the school day (up from 22.34 min/d at baseline). Physical activity levels increased slightly in the comparison group in reported levels of light exercise

 
Stolley 19971. Fatness assessed by weight and height at baseline and at 12 weeks (end of the intervention):
OUTCOME: No statistically significant change between intervention and control.
1. Dietary Intake:
OUTCOME: Significant reductions found in intervention mothers' daily saturated fat intakes and percentage of energy from fat when compared to controls. Also intervention girls had statistically significant reductions for percentage energy from fat when compared to controls.
Story 2003a1. Fatness assessed by repeat measures of height and weight (and calculated BMI) at baseline and end of pilot:
OUTCOME: No differences between intervention and control.
2. Waist circumference:
OUTCOME: No differences between intervention and control.
3. Dual X-Ray Absorptiometry (DEXA) for % Body fat
OUTCOME: Not done.

4. Physical activity: CSA accelerometer,
OUTCOME: No differences between intervention and control.
5. a modification of the Self-Administered Physical Activity Checklist (SAPAC),
OUTCOME: Not reported.
6. GEMS Activity Questionnaire(GAQ) computerised
OUTCOME: No differences between intervention and control.

7. Dietary intake measured by two 24 hour recalls using Nutrition Data System computer programme (NDS-R).
OUTCOME: No differences between intervention and control.
Psychological variables:
1. Over concern with weight or shape:
OUTCOME: Intervention significantly better than control.

2. Diet: Healthy choice Behavioural Intentions:
OUTCOME: Intervention significantly better than control.
3. Self-Efficacy for Healthy Eating
OUTCOME: No differences between intervention and control.
4. Diet knowledge:
OUTCOME: Intervention significantly better than control.

5. Physical Activity Outcomes Expectations, and a self-efficacy measure.
OUTCOME: No differences between intervention and control (except physical activity preference).

6. Parental reported diet
OUTCOME: Significant differences with intervention better than control: % energy from fat and low fat food practices.
7. Parental reported physical activity:
OUTCOME: No differences between intervention and control.
Taylor 2008

MEASURES: Weight, Height

OUTCOMES:
Post-intervention:  Adjusted mean BMI Z-score was lower in intervention relative to control children by -0.12 units (95% CI: -0.22 to -0.02).

Follow-Up: Mean BMI z score (and 95% CI) remained significantly lower in intervention children in the whole group (n = 554, -0.17; -0.25 to -0.08) and in the group who underwent at least 1 (n = 389;-0.19;-0.24 to -0.13) or 2 (n = 256;-0.21;-0.29 to -0.14) full years of intervention.

MEASURES: Prevalence Overweight and obesity

OUTCOMES:
Post-intervention:  Although the risk of being overweight or obese (18) at year-end in intervention compared with control children (odds ratio 0.55; 95% CI: 0.19 to 1.48) did not achieve statistical significance, more intervention children who were overweight at baseline tended to be classified as normal weight at year-end (12 of 49, 24%) than control children (10 of 65, 15%). Furthermore, 10 of 158 (6%) intervention children became overweight during the year compared with 13 of 112 (12%) control children.

Follow-up: Intervention children were less likely to be overweight, but only in those who were present for the full intervention (n = 256; Relative Risk: 0.81; 95% CI: 0.69, 0.94).  9 (10%) intervention and 10 (14%) control children became overweight during the 2 yr after the cessation of the intervention project.  12 (30%) intervention and 14 (25%) control children who were overweight at baseline were not overweight at follow-up.  13 (10%) intervention and 18 (17%) control children became overweight.  20 (30%) intervention and 20 (24%) control children became normal weight

MEASURES: Physical activity

OUTCOMES: Post-intervention average accelerometry counts at 1 year were 28% (95% CI: 11 to 47%) higher in intervention compared with control children after adjusting for age, sex, baseline values and school.

Intervention children spent less time in sedentary activity (ratio 0.91, P = 0.007) and more time in moderate (1.07, P = 0.001) and moderate/vigorous (1.10, P = 0.01) activity.

MEASURES: Waist circumference, blood pressure, pulse rate

OUTCOME:  No intervention effect was observed

 

Vizcaino 2008

MEASURE: BMI

OUTCOMES: No significant differences between intervention and control groups

MEASURES:  Triceps skin-fold thickness (TST)

OUTCOMES: Significant reduction in TST in intervention children compared with controls for both boys (-1.14mm; 95%CI: -1.71, -0.57; p<0.001) and girls (-1.55mm; 95%CI: -2.38, -0.73; p<0.001).

MEASURES:  Percentage body fat

OUTCOMES: Significant reduction in % body fat in girls (-0.58%; 95%CI: -1.04, -0.11; p=0.02). No significant differences between intervention and control for boys.

MEASURES:  Blood pressure, total cholesterol, triglycerides, apo A and apo B

OUTCOMES: Compared with controls, intervention children had lower apo B levels and higher apo A-1 levels.

Intervention was not associated with any significant changes in total cholesterol, triglycerides or blood pressure, with the exception of diastolic blood pressure, which rose in intervention versus control boys.

Warren 20031. Fatness assessed by repeat measures of height and weight.
OUTCOME: No significant changes in the rates of overweight and obesity were seen as a result of the 3 different interventions (Be Smart, Eat Smart, Play Smart). Post-intervention, the change in prevalence of overweight from baseline was -1, +5, 0 for the Be Smart, Eat Smart, Play Smart groups, respectively. Post-intervention, the change in prevalence of obesity from baseline was -1, -2, 0 for the Be Smart, Eat Smart, Play Smart groups, respectively.
1. Nutrition knowledge:
OUTCOME: all conditions improved their knowledge, I vs C not reported. No gender differences.
2. Diet:
OUTCOME: significant increase in vegetable consumption (P<0.05) and fruit (P<0.01). However, 24h recall showed no significant differences between the groups or genders at base line or at follow-up.
3. Physical activity:
OUTCOME: No intervention effect was found in either the children's or parents questionnaires.
Table 4. Results 13-18 years
Study IDPrimary OutcomesSecondary Outcomes
Ebbeling 2006

MEASURE: BMI

OUTCOME: Change in BMI was not significantly different between groups (mean ± SE: 0.07 ± 0.14 kg/m2 for intervention group and 0.21 ± 0.15 kg/m2 for control group). This varied according to baseline BMI, with the intervention effect significant in those subjects with baseline BMI > 30 kg/m2 and a significant difference between BMI change in intervention and control subjects among those in the upper baseline-BMI tertile (-0.63 ± -0.23 kg/m2 vs +0.12 ± 0.26 kg/m2).

MEASURE: Energy intake from SSB (kJ)

OUTCOME: Energy intake from SSB decreased in intervention subjects (-1201 ± 836 kJ) and this was significantly different from control (-185 ± 945 kJ) (P < 0.0001)

MEASURE: Noncaloric beverage intake (mL)

OUTCOME: Significant increase in intervention subjects compared with control (p=0.002)

MEASURE: Physical activity (MET)

OUTCOME: No difference between intervention and control

MEASURE: Television viewing (hours)

OUTCOME: No difference between intervention and control

MEASURE: Total media time (hours)

OUTCOME: No difference between intervention and control

Haerens 2006; Table 3

MEASURES: BMI

OUTCOMES:

Prevalence of overweight was not different between groups (baseline:18.5 ± 38.8 and post-intervention: 18.6 ± 38.9).

MALES: No significant positive intervention effects on BMI were found.

FEMALES: After 1 year of intervention, there was a trend for a significant lower increase in BMI in the intervention group with parental support when compared with the control group (F = 3.04, P < 0.08). After 2 years of intervention, there was a significant lower increase in BMI (F = 12.52, P < 0.05) and BMI z-score (F = 8.61, P < 0.05) in the intervention with parental support group compared with the control group. There was also a significantly lower increase in BMI z-score (F = 2.68, P = 0.05) in the intervention with parental support group compared with in the intervention-alone group.

MEASURES:  Physical activity

OUTCOMES:

MALES: school-related physical activity increased significantly more in the intervention groups compared with the control group (P < 0.05).  Using accelerometry, there were significantly lower decreases in physical activity of light intensity in the intervention groups (-6 min/day) compared with the control group (-39 min/day, P < 0.001). Where

time spent in MVPA remained stable in the intervention group, it significantly decreased (-18 min/day) in the control group (P < 0.05).

 

FEMALES: Time spent in physical activity of light intensity decreased significantly less in the intervention groups (-2 min/day) compared with the control group (-20 min/day, P < 0.05).

MEASURES: fat intake, fruit, water and soft drinks

OUTCOMES:

MALES: No differences between groups

FEMALES: Decreases in fat intake and percent energy from fat were significantly higher in the intervention groups (-20 g/day) when compared with the control group (-10g/day, P < 0.05).

In either males or females there were no positive intervention effects on  fruit, water and soft drink consumption

Parental involvement did not increase intervention effects

NeumarkSztainer 2003The primary outcomes were the feasibility i.e. sustainability and satisfaction of the intervention as assessed by a various satisfaction, behaviour change, personal change and socio-environmental support variables. All did not achieve significance except:
1. Change in Physical Activity Stage:
OUTCOME: Intervention significantly greater than controls at 8 month follow-up only.

1. BMI

2. Diet and physical activity related behaviours

OUTCOME: No differences between intervention and control.

Pate 2005

MEASURES: % of girls who reported participating in vigorous physical activity during an average of 1 or more 30-minute blocks per day during the 3-day reporting period.

OUTCOMES: At follow-up, the prevalence of vigorous physical activity was greater in the LEAP intervention schools than in control schools (45% vs 36% P = 0.05) after adjusting for baseline differences. When missing data at follow-up were imputed by applying a regression method, this prevalence difference increased in statistical significance (P < 0.05).

MEASURES: % overweight or at-risk for overweight

OUTCOMES: No significant differences between intervention and control schools at follow-up.

Patrick 2006

MEASURES: Physical activity
OUTCOMES: Both groups improved in all behaviours with no significant difference between intervention and control.

Boys in the intervention group increased their number of active days per week (P = 0.01) compared with control adolescents.

MEASURES: Sedentary behaviours based on a composite self-report measure including time spent watching television, playing computer/video games, sitting talking on the telephone, and sitting listening to music

OUTCOMES: Significant (P < 0.001) between-group difference for the change in sedentary behaviours (intervention -21% versus control +4.8% in girls and intervention -24% versus control +2.4% in boys).

MEASURES: % of energy from fat and servings per day of fruits and vegetables

OUTCOMES: More girls in the intervention group met the guideline for maximum % of daily calories from saturated fat at 12 months. Both groups increased their daily fruit and vegetable intake with no differences between groups.

MEASURES: BMI

OUTCOMES: No differences at 12 months between groups for BMI z scores.

Peralta 2009

MEASURES: Height and weight

 

OUTCOMES: No significant differences between groups post-intervention

 

 

MEASURES: Waist circumference

 

OUTCOMES: No significant differences between groups post-intervention

 

MEASURES: Percentage body fat assessed using Tanita body fat analyser

 

OUTCOMES: No significant differences between groups post-intervention

MEASAURES: Cardiorespiratory fitness (by 20-metre Multistage Fitness Test)

OUTCOMES: No significant differences between groups post-intervention

MEASURES: Physical activity measured using Actigraph accelerometers

OUTCOMES: Only significant difference was for intervention boys to have significantly less weekend vigorous physical activity (min/day)  than comparison boys ( ?5.3; 95% CI: ?10.4, ?0.2; P = 0.045)

 

MEASURES: Time spent using small screen recreation measured using the Adolescent Sedentary Activities Questionnaire

OUTCOMES: No significant differences between groups post-intervention

MEASURES: Sweetened beverage and fruit consumption measured using a validated Food Frequency Questionnaire

OUTCOMES: No significant differences between groups post-intervention

Singh 2009

MEASURE: BMI

OUTCOME: No significant differences between intervention and control groups

MEASURE: Hip and waist circumference

OUTCOME: After 8 months, there were significant differences in hip circumference for intervention compared with control (mean difference in of 0.53 cm; 95% CI 0.07 to 0.98) in females. In males, the intervention resulted in a significant difference in waist circumference (mean difference, -0.57 cm; 95% CI, -1.10 to -0.05).

At the 20 month follow-up assessment, waist circumference in boys was significantly lower in the control group. In girls at 20 months, there was no significant difference between intervention and control.

MEASURE: Skinfold thickness

OUTCOME: Significant difference in sum of skinfolds for intervention females compared to control females were observed at 8 months (mean difference -2.31cm; 95% CI -4.34 to -0.28).

In boys, there was a significant intervention effect on triceps (-0.7mm; 95%CI: -1.2 to -0.1mm), biceps (-0.4mm; 95%ci: -0.8 to -0.1mm) and subscapular (-0.5mm; 95%CI: -1.0 to -0.1mm) skinfold thickness at 20 months. In girls, there was a significant intervention effect on biceps skinfold thickness (-0.7mm; 95%CI: -1.3 to -0.04mm) and the sum of skinfold thickness at 20 months (-2.0mm; 95%CI: -3.9 to -0.1mm)

MEASURE: Aerobic Fitness

OUTCOME: No reported difference between intervention and control at 8 months.

MEASURE: Consumption of sugar-containing beverages

OUTCOME: While consumption of sugar-containing beverages was significantly lower among students of the intervention schools at both 8- and 12-month follow-ups, there were no significant differences at 20 months.

MEASURE: Consumption of high-energy snacks

OUTCOME: No significant intervention effects.

MEASURE: Screen viewing behaviour

OUTCOME: Numerical differences in screen-viewing behaviour consistently favoured students from intervention schools at all follow-up measurements, with statistically significant differences in favour of boys of the intervention group at 20 months (-25 min/d; 95%CI: -50 to -0.3 min/d).

MEASURES: Active commuting to school

OUTCOMES: No significant intervention effects.

Webber 2008

MEASURES: Physical activity

OUTCOMES: At 2 years, there was no difference in adjusted MET-weighted minutes of MVPA between 8th-grade girls in intervention compared with control schools. At 3 years, 8th-grade girls in intervention schools had 10.9 more MET-weighted minutes of MVPA than those in control schools (P = 0.03). The decrease in MET-weighted minutes of MVPA in intervention schools from 6th grade to 8th grade was 6% compared with 15% in control schools. These differences in physical activity were seen more during weekdays than weekends.

There were differences in the number of MET-weighted minutes of MVPA among the three largest racial/ethnic groups. After adjusting for 6th-grade activity differences, both MET-weighted minutes and unweighted minutes of MVPA were higher for white girls than for African-American and Hispanic girls at both 2 years and 3 years.

MEASURES: Body composition

OUTCOMES: Changes in triceps skinfold thickness and percent body fat were similar between intervention and control groups

Risk of bias in included studies

All included studies were assessed for their risk of bias across a number of domains known to be important for internal validity, that is, the extent to which results of included studies should be believed. This was conducted using The Cochrane Collaboration’s 'Risk of bias' tool, a domain-based evaluation in which assessments are made separately for each domain (Higgins 2008). The domains of interest are sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting and other sources of bias.

Thirty studies had a high risk of bias for one or more domains. Across all domains, most studies were rated as either low or unclear risk of bias, with the proportion of studies rated in these categories for each domain ranging from approximately 70% to 90% (Figure 2). Unclear risk of bias was the most common rating for all but two domains (incomplete outcome data and other bias). Studies received a rating of unclear for a domain when there was insufficient information included in the relevant papers for this to determined. This highlights the ongoing need for diligent reporting of research methods, which is vital for transparency and to maximise the potential utility of results. End-users of research must have adequate information to enable informed decisions about the internal and external validity of research findings.

Figure 2.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Selection bias (sequence generation and allocation concealment)

Eleven studies were rated as having a high risk of bias for sequence generation and 10 studies were rated as having a high risk of bias for allocation concealment. The majority of these (n = 9) were non-randomised studies (Fernandes 2009; Hamelink-Basteen 2008; Harrison 2006; Jouret 2009; Kain 2004; Müller 2001; Sanigorski 2008; Taylor 2008; Pangrazi 2003), which were all rated as having a high risk of bias for both domains relating to selection bias. Selection bias is an inherent risk in non-randomised studies. This does not mean that this risk would always be likely to seriously affect the outcomes of the study. There will be differing degrees to which this could be the case. Some non randomised studies in this review sought to address the potential for selection bias with strategies such as selecting control groups that were matched for known confounders, or including all eligible participants within an entire community or setting to receive an intervention (for example, all schools in a given area) rather than selecting a particular subset of the community. Others however, selected intervention sites based on existing programmes or prevalence of obesity which may have confounded the results.

One cluster RCT was rated as high risk of bias for sequence generation since schools were "randomly assigned" to three experimental conditions, however, an additional school was recruited and added to the control group after this process was conducted (Sallis 1993). Another cluster RCT was rated as high risk of bias for this domain since, despite stating that schools were chosen randomly, the design is described by the study authors as quasi-experimental (Coleman 2005). Two cluster RCTs were assessed as high risk of bias for allocation concealment. One recruited participants after the schools were randomised and potential participants knew about the interventions that they were enrolling in (NeumarkSztainer 2003). The other performed recruitment over two periods and during the second recruitment period, parents/students were informed of the intervention assignment of the school (Gutin 2008). This may have affected the characteristics of participants who agreed to participate in these studies.

The remaining study designs were RCTs or cluster RCTs and of these, we rated 18 studies low risk of bias for sequence generation and 16 studies as low risk of bias for allocation concealment. This means that 18 studies clearly specified a method for generating a truly random sequence. We rated the remainder of studies as having an unclear risk of bias. Allocation concealment was often not clearly specified in the study report, however, cluster RCTs received a rating of low risk of bias for this domain if the unit of allocation was by institution or community and allocation was performed on all units at the start of the study, as recommended by the EPOC 'Risk of bias' tool for studies with a separate control group (Cochrane EPOC 2009).

Performance and Detection bias (blinding)

We judged 11 studies as having a low risk of performance bias based on the blinding of outcome assessors. Most studies did not blind participants or staff delivering the intervention as it is often not possible to blind interventions of this nature. This means that there may be differences in the way that participants were treated in the intervention and control groups, perhaps exposing them to factors that might be considered external to the particular intervention of interest. However, obesity prevention interventions, like many public health interventions, will often involve important implementation or contextual factors that cannot always be separated from the intervention itself such as who delivered the intervention, setting, resources available. For this reason, it is important that as much information as possible is captured about these potential factors so they can be taken into account by anyone exploring the outcomes of the intervention and considering replication in another setting.

Ten studies were judged as having a high risk of bias, and this was usually as a result of this information about the study not being blinded being clearly reported in the study paper. The remainder of studies were rated as unclear because blinding information was not reported, although it was likely that most of these did not implement blinding. It is probably more meaningful to consider blinding at the outcome measurement level (detection bias), since some outcomes would be more likely to be affected by lack of blinding than others. This is discussed below for BMI, the outcome included in the meta-analysis for this review.

Attrition bias (incomplete outcome data)

We assessed more than half of the included studies as being at low risk of attrition bias (Amaro 2006; Beech 2003; Caballero 2003; Coleman 2005; Dennison 2004; Donnelly 2009; Ebbeling 2006; Epstein 2001; Fernandes 2009; Foster 2008; Gortmaker 1999a; Harvey-Berino 2003; Kain 2004; Lazaar 2007; Macias-Cervantes 2009; Mo-Suwan 1998; NeumarkSztainer 2003; Pate 2005; Patrick 2006; Reed 2008; Reilly 2006; Robbins 2006; Robinson 2003; Sahota 2001; Sanigorski 2008; Sichieri 2009; Simon 2008; Singh 2009; Spiegel 2006; Story 2003a; Vizcaino 2008; Warren 2003; Webber 2008). Decisions were based on the provision of an adequate description of participant flow through the study with missing outcome data relatively balanced between groups and judged to be unlikely to be related to the outcomes of interest.

We assessed four studies as being at high risk of attrition bias for the following reasons: unbalanced completion rates in study groups and reasons for missing data not provided; missing data not provided by study group; differences in characteristics related to study outcomes between completers and non-completers (Haerens 2006; Müller 2001; Sallis 1993; Stolley 1997).

Reporting bias (selective reporting)

Most studies had an unclear risk of reporting bias, with three assessed as being at low risk (Harrison 2006; Sanigorski 2008; Singh 2009) and seven at high risk of reporting bias. According to the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2008), it is likely that most studies fall into the category of unclear for this domain, due to the difficulty in establishing what outcomes may have been collected and not reported. Publishing of study protocols prior to study commencement or at least prior to study completion, has contributed significantly to increasing our ability to detect selective outcome reporting, however publication of study protocols is still relatively uncommon in public health.

We assessed studies with a published protocol that confirmed all specified outcomes were included in the study report as low risk of reporting bias. Studies without a published protocol, we assessed as unclear. We assessed studies as being at high risk of reporting bias when an outcome measure was specified and results not reported either at baseline or at follow-up. Of the seven studies, four studies were following a common protocol which noted percentage body fat as an outcome measure of interest. All four studies reported this at baseline and not at follow-up so it is not clear what changes occurred in this outcome measure as a result of the intervention (Baranowski 2003; Beech 2003; Robinson 2003; Story 2003a).

Other bias

Most studies (n = 35) were assessed as being at low risk of other sources of bias and 17 were assessed as being at high risk for other sources of bias. Of the studies we assessed as being at high risk of bias, a common issue was that the units of analyses were inadequately addressed, with randomisation at a group level, but analysis conducted at an individual level without clearly identifying if, or how, the effects of clustering were accounted for. Other issues included significant differences in outcome measures between groups at baseline and likely contamination between intervention groups. One study implemented a cross-over study design in which every alternating year, intervention schools became control schools and vice versa (Müller 2001). Given obesity prevention interventions seek to change behaviour, this type of study design is compromised due to the carry-over effects of the intervention. This study remained included in the overall narrative because it met inclusion criteria, however, it was not included in the meta-analysis.

Risk of bias for studies included in the meta-analysis

The meta-analysis for this review included all 49 studies reporting BMI/zBMI data and reporting a mean and associated measure of variance. BMI was the most common measure of adiposity reported. Six studies that were assessed as being at high risk for selection bias were included in the meta-analysis. In terms of blinding, seven studies assessed as at a high risk of bias were included in the meta-analysis, with six studies assessed as at a low risk of bias, and the remainder unclear. Since BMI was measured and can be viewed as an objective measure (rather than self-reported measures), it is less likely to be affected by the lack of allocation concealment or blinding, so probably had little effect on the meta-analysis results. Three of the six studies assessed as high risk for reporting bias were included in the meta-analysis. Although studies were not excluded from the meta-analysis on the basis of 'Risk of bias' assessments, it is important to note that three of the four studies identified as being at high risk for attrition bias did not appear in the meta-analysis. Also, the study identified as a “cross-over design” (Müller 2001) leading to significant concern for potential biases was not included in the meta-analysis. A funnel plot was also generated to examine potential publication bias (Figure 3). The funnel plot shows an uneven distribution of studies, indicating that there may be small study bias occurring. Bias of this type may lead to an inflated assessment of the intervention effectiveness as small negative studies appear to be under-represented.

Figure 3.

Funnel plot of comparison: 1 Childhood obesity interventions versus control by age groups 0-5, 6-12 and 13-18 years, outcome: 1.1 Standardised mean change in Body Mass Index (BMI/zBMI) from baseline to post-intervention.

Effects of interventions

A meta-analysis was conducted to investigate the impact of included interventions on BMI or zBMI, the most common measures of adiposity reported, as a measure of effectiveness (Analysis 1.1). The meta-analysis revealed significant heterogeneity which was explored by age group (Figure 4), type of intervention (Figure 5), setting of intervention (Figure 6), duration of intervention (12 weeks versus >12 weeks) (Figure 7) and by randomisation (Figure 8). The heterogeneity was not explained by any of these factors, other than setting in the 0-5 age group. For this reason, the studies were organised into subgroups based on the age group of the child participants (0-5, 6-12, 13-18 years) and this decision was based on what would be meaningful for decision makers. Further breakdown by age was not possible given the number of studies in the 0-5 and 13-18 groups. 

Figure 4.

Forest plot of comparison: 1 Childhood obesity interventions versus control by age groups 0-5, 6-12 and 13-18 years, outcome: 1.1 Standardised mean change in Body Mass Index (BMI/zBMI) from baseline to post intervention.

Figure 5.

Forest plot of the standardised mean change in body mass index (BMI/zBMI) from baseline to post intervention for childhood obesity interventions versus control grouped by intervention type (physical activity, dietary, combined physical activity/dietary)

Figure 6.

Forest plot of the standardised mean change in body mass index (BMI/zBMI) from baseline to post intervention for childhood obesity interventions versus control grouped by setting

Figure 7.

Forest plot of the standardised mean change in body mass index (BMI/zBMI) from baseline to post intervention for childhood obesity interventions versus control grouped by duration of intervention (short term and long term)

Figure 8.

Forest plot of the standardised mean change in body mass index (BMI/zBMI) from baseline to post intervention for childhood obesity interventions versus control grouped by risk of bias based on randomisation (high risk=non-randomised; unclear risk=method of randomisation or sequence generation unclear; low risk=randomisation occurred appropriately)

Study outcomes are presented by target age groups, with three categories: 0-5 years, 6-12 years, 13-18 years. In all cases, the outcome data are summarised or reported using the determination of the study authors as to primary and secondary outcomes, to ensure consistency with the design of the studies and published results.  

Outcome measures

Adiposity

Measures of adiposity include direct measures and proxy measures and each measure has limitations. The most direct method of adiposity used in the included studies was DEXA (Dual Energy X-ray Absorptiometry). (Mei 2002) This method is highly sensitive, precise and accurate and allows the determination of the amount of fat mass and fat-free mass, as well as the distribution of the fatness. The method, however, is expensive and requires participants to attend a clinic-type setting for the DEXA scan, therefore, this method is often not feasible for trials or routine measurement. 

A more commonly used method of measuring body fatness is by measuring skinfold thickness at a variety of sites (e.g. bicep, tricep, subscapular, suprailliac, medial calf). Standard equations are then used which sum the thickness of various sites to determine percentage body fat. Fat distribution may also be determined using this method. Although this measurement is simple, inexpensive and quick, poor reliability is often a limitation. Reliability can be improved through operator training, and taking duplicate or triplicate measurements.       

Measurement of waist and hip circumference are also commonly used measures of adiposity. However, several sites can be used to measure these circumferences (e.g. waist circumference can be measured at the umbilicus, mid-point between the lowest rib and iliac crest, or a point 2 cm below the lowest rib), which can limit the ability to compare measures across studies. Waist and hip circumferences provide a measure of fat distribution (central and peripheral adiposity), rather than amount of overall adiposity. Measurement is simple, inexpensive and quick, although again, reliability is a problem. Reliability can be improved through operator training, and taking duplicate or triplicate measurements.      

The most commonly used method for estimating body fatness is BMI (body mass index).  BMI is derived from measures of height and weight, and calculated by dividing weight (in kilograms) by the square of height (in metres). BMI is a proxy measure of adiposity, which has been shown to correlate well with fat mass measured by DEXA (ref), although it does not always provide an accurate indicator of fatness at an individual level. It is widely used as it is simple, inexpensive and quick.  BMI is also used to calculate standardised BMI (zBMI) score, which is BMI standardised on age and gender against a reference population. There are a number of quality reference populations in use internationally (e.g. Center for Disease Control (CDC), World Health Organization (WHO)), although country-specific reference populations are also sometimes used.  

To determine weight/nutritional status (e.g. underweight, healthy weight, overweight, obese) a number of methods are available. Commonly used methods include using BMI cut-offs that are age and gender specific such as those developed by the IOTF (Cole 2000; Cole 2007). The IOTF cut-offs were generated from pooled international child anthropometric data, with age and gender specific BMI cut-offs established for determining the child’s weight status (Cole 2000). In more recent times, the WHO has developed a new growth reference and associated cut-off points for school-aged children and adolescents that are closely aligned to the WHO Child Growth Standards produced in 2006 (de Onis 2004; de Onis 2007), and the recommended adult cut-offs for overweight and obesity at 19 years. Another method is using percentile based cut-offs for BMI-for-age percentiles or weight-for-age percentiles of a reference population (e.g. CDC). 

In all cases, the prevalence of these categories can easily be determined as a percentage of the measured population, and change in weight status (e.g. remission or incidence of obesity) can be determined longitudinally. It should be noted however, that terminology is not consistent internationally, with obese, overweight, and at risk-of-overweight all being used to refer to levels of adiposity that are associated with increased disease risk.   

Behaviours

A variety of behavioural measures have been reported in the included studies. The behaviour itself can be measured (minutes spent in moderate-to-vigorous physical activity) or an indicator related to the behaviour can be measured (number of occasions of organised sports per week). The choice of measure is often determined by cost, equipment requirements, feasibility, acceptability to participants, scale (number of participants), access to participants, and also the objective of the intervention and therefore evaluation requirements. Behaviours may also be objectively measured (accelerometry, observation) or subjectively measured (self-report, parent-report). Behavioural data that are reported by parents, children or others are subject to social desirability bias and recall bias. Reliability and accuracy may also be affected by comprehension and literacy skills of children where survey-based methods are used. This can be partly overcome by a run-in period. The process of data collection can also lead to changes in behaviour (e.g. increased activity or changed diet) which can produce data that do not reflect usual patterns of the behaviour. A further source of bias can be introduced by non-blinding of data collectors who may inadvertently introduce artificial differences in measurements between groups. Given the difficulty of measuring behavioural data, it is recommended to use measures that have been validated and psychometric properties assessed, to ensure that the data collected accurately and reliably measure the behaviours of interest. In the Characteristics of included studies, we have reported whether or not studies have assessed the reliability of the outcome measures used.   

Section 1: 0-5 years

This section describes studies targeting young children, delimited as those aged 0-5 years. It should be noted however, that of the eight studies targeting this age group, all but one study (Harvey-Berino 2003), includes children with a mean age greater than three years at baseline, and one of these (Keller 2009) recruited children aged four to seven years. 

Effectiveness

Of the eight studies targeting young children, two tested the same intervention design with different target groups (Hip Hop to Health Jnr (Fitzgibbon 2005; Fitzgibbon 2006).

All but one study (Jouret 2009), provided appropriate BMI or zBMI data for inclusion in the meta-analysis, which showed an effect size of  -0.26 (-0.53 to 0.00), see Analysis 1.1. This can be interpreted to mean that children in the intervention group had a change in BMI/zBMI from pre- to post-intervention that was 0.26 units less than what was observed in the control group. Although the studies are heterogeneous and the analysis only just failed to reach statistical significance (P = 0.05), there is a trend towards a positive intervention effect. With subgroup analysis of those studies that were either home-based or involved a healthcare setting (Harvey-Berino 2003; Keller 2009), heterogeneity was removed and a highly significant effect size of -1.08 (-1.39 to -0.77) was observed (P = 0.0001), although the sample size is small (Intervention: 66, Control: 154). This analysis did not include all interventions set outside the education setting, as the study by Jouret 2009 reported only medians and interquartile ranges and therefore could not be included in the analysis. Jouret found that after the two-year intervention period, children in both the basic intervention group (health-service-based; EPIPOI-1) and the reinforced intervention group (health-service-based + kindergarten-based; EPIPOI-2) had significantly lower prevalence of overweight (BMI ≥ 90th percentile) than the control group. In this study, subgroup analysis revealed there were differences in effects if the schools were in underprivileged areas. Specifically, testing the EPIPOI-1 intervention, median change in zBMI was significantly lower in the intervention group (compared with controls) only in underprivileged schools (difference in zBMI in intervention group from control group of -1.0 units), while the median change in zBMI was significantly lower in the EPIPOI-2 intervention group in both underprivileged (difference in zBMI -0.85) and non-underprivileged (difference in zBMI of -0.19) schools (Jouret 2009). Therefore, although Jouret was not included in the meta-analysis, the size of the effects for participants recruited from underprivileged schools are consistent with those in the meta-analysis, which further supports the findings.

Alternative sub-group analysis of those studies conducted in an education-type setting also reduced heterogeneity considerably (I2 = 27%) but revealed a non-significant intervention effect of -0.03 (-0.15, 0.09; P = 0.58), with n = 796 and n = 799 children in intervention and control groups, respectively. These results suggest that for children aged 0-5 years, interventions set outside education settings are more effective, which may relate to a number of factors including the level of parent engagement.   

Outcomes from individual studies

Adiposity

Results for outcomes measured in each study for this age group are presented in Table 2. Of the outcomes measuring adiposity or prevalence of overweight or obesity, only two studies reported significant differences between groups immediately post-intervention; these were also the longest studies in this group. Keller 2009 reported a stabilisation of zBMI in the intervention group after the 12-month intervention period, which was significantly different to the increase observed in the control group. Jouret found that after the two-year intervention period, children in both the basic intervention group (health-service-based; EPIPOI-1) and the reinforced intervention group (health-service-based + kindergarten-based; EPIPOI-2) had significantly lower prevalence of overweight (BMI ≥ 90th percentile) than the control group. Subgroup analysis revealed there was only a significant difference between groups if the schools were in underprivileged areas. The effects of the intervention on zBMI are described above.    

Behaviours

On balance, only modest behavioural impacts were achieved from the interventions in this age group. 

Diet-related

Five of the eight interventions targeted both dietary and physical activity related behaviours combined. Dietary changes were reported in only two studies, with Fitzgibbon 2005 reporting a significantly lower intake of saturated fat in intervention children at one-year follow-up (P = 0.002), but not post-intervention or at two-year follow-up. Interestingly, this impact in the African American participants was not observed with the same intervention in the Latino participants (Fitzgibbon 2006). Keller 2009 reported significantly lower energy intake and percentage protein intake in the intervention group post-intervention. 

Physical Activity-related

Three of the eight interventions targeted physical activity related behaviours only. Of the range of physical activity related measures captured, the only positive impact was in one study that reported children in the intervention group had significantly higher performance in movement skills tests than children in the control group at six-month follow-up (95% CI: 0.3 to 1.3; P = 0.003) after adjustment for sex and baseline performance (Reilly 2006).

Sedentary-related

Dennison 2004 reported that television viewing was significantly reduced by the 12-week intervention (the number of children watching more than two hours of television/day was significantly lower in the intervention group, as was total number of hours watched), although time spent playing computer games was not different between groups. 

Cardiovascular disease risk factors

In relation to the impact of the interventions on cardiovascular disease risk factors other than adiposity, no studies measured effects on blood pressure, heart rate, blood lipids, or cardiovascular fitness.

Assessment of outcomes by gender

Outcomes were reported by gender in three studies.  Mo-Suwan 1998 reported that girls in the intervention group had a lower likelihood of having an increasing BMI slope than the control girls (odds ratio (OR): 0.32; 95% CI: 0.18 to 0.56).  Reilly 2006 reported the change in score for fundamental movement skills was improved more in females than males, with the average difference in improvement being 0.7 units (95% CI: 0.3 to 1.1; P = 0.001). Keller 2009 reported that there were no differences in outcomes by gender. In summary therefore, there is insufficient evidence from these studies to determine if either gender benefits more from interventions in young children, although there is some evidence that females tend to do better.    

Maintenance/Sustainability of effects

Four studies assessed maintenance or sustainability of impacts (Fitzgibbon 2005; Fitzgibbon 2006; Mo-Suwan 1998; Reilly 2006). In the Fitzgibbon studies, the lack of effects observed post-intervention were maintained one and two years later (Fitzgibbon 2006). After one-year follow-up, the increase in BMI for children in intervention was 0.33 units (P = 0.46), and the mean increase for children in control schools was 0.48 units (P = 0.46). Similar to the results in BMI, the change in BMI z score was also not significantly different between the intervention and control groups at one-year follow-up (0.00 and 0.07, respectively; P = 0.56). At two-year follow-up, the mean increase in BMI was 0.46 units in intervention children and 0.70 units in control children (P = 0.34), and the BMI z score change was -0.13 and 0.00 for intervention and control children, respectively (P = 0.34). Diet and physical activity-related measures were also not different between groups. Reilly 2006 showed that at follow-up six months post-intervention, there were no differences in BMI/zBMI or activity and diet-related behaviours, although children in the intervention group had significantly higher performance in movement skills tests than control children at six-month follow-up (P = 0.003; 95% CI 0.3 to 1.3) after adjustment for sex and baseline performance. Mo-Suwan 1998 reported that six months post-intervention, the prevalence of obesity in the control group decreased from 12.2% at baseline to 9.4% after the intervention at 29.6 weeks and was 10.8% at 29.6 weeks plus six months. In the exercise intervention group, the prevalence of obesity was 12.9% at baseline, 8.8% at 29.6 weeks and 10.2% six months later. It is not known (information not available) if the changes at 29.6 weeks plus six months are statistically significant, although only non-significant changes in prevalence were observed immediately post-intervention.

In summary, follow-up after the completion of these short-term interventions revealed a lack of further impact on child adiposity and obesity-related behaviours,

Equity

This review sought to identify studies which had reported on socio-demographic characteristics known to be important from an equity perspective. For this process, the PROGRESS (Place, Race, Occupation, Gender, Religion, Education, Socio-economic status (SES), Social status) framework was utilised (Ueffing 2009). All studies reported the gender of participants at baseline. Four studies reported the race of participants and the level of education of parents (Dennison 2004; Fitzgibbon 2005; Fitzgibbon 2006; Harvey-Berino 2003) and two studies included information about the employment status of parents at baseline (Dennison 2004; Harvey-Berino 2003). Mo-Suwan 1998 included information on SES of participants at baseline based on parental income. Jouret 2009 reported some indicators related to place (the proportion of participating schools in a rural or urban region) and SES (the proportion of participating schools in an urban region which were also in an area considered to be underprivileged). When analysing data on outcomes, only three studies analysed results by any of the PROGRESS items. Mo-Suwan 1998 and Reilly 2006 analysed outcomes by gender and Jouret 2009 analysed outcomes by the same indicators of place and SES that were collected at baseline (these data are discussed above).

Of the eight studies targeting this age group, only Jouret 2009 attempted to analyse the outcomes of the intervention by a PROGRESS category other than gender, showing differential impacts of the intervention in underprivileged schools.  The lack of analysis by a measure of equity or SES limits our ability to assess the effectiveness of the interventions in reducing health inequities, however, it should be noted that the participants in most of the studies were from high risk, underprivileged communities. In this sub-set of studies, participants are from Thailand, USA (African American, Native American, Latino), France and Scotland, allowing us to assess the utility of approaches in a variety of contexts. 

Harm-adverse/unintended effects

It is critical that measures of harm or unintended consequences are included in evaluations targeting eating and activity-related behaviours, to ensure that interventions are safe and appropriate. This is particularly important in very young children, as this is an important growth period and adequate nutrition is critical. Also, given the short intervention periods of most of the studies targeting this age group, any impacts on diet, weight and fatness need to be carefully considered. None of the eight studies targeting 0-5 year olds explicitly reported unintended outcomes or measures of harm, however, Fitzgibbon 2006 reported there were no adverse events during the trial, although no data were provided or information on what measures were used.

Implementation Factors

In order to fully understand the outcomes of the intervention, an understanding of the development and implementation is required. This allows interpretation of the findings in an appropriate context and also an assessment of the applicability, transferability and appropriateness of the intervention for similar or different population groups. The reporting of the theoretical basis, implementation factors and process evaluation are discussed below. 

Design and theoretical basis

Five of the eight studies were both diet and physical activity combined, three were physical activity interventions only. All but one of the studies had short intervention periods (< one year; six studies ≤ 24 weeks), with only Jouret 2009 having a longer intervention period (two years). Of the seven study designs, theoretical basis was only explicitly reported in one (Fitzgibbon 2006). Despite this, we can surmise that behaviour change theory informed the design of five of the studies (Dennison 2004; Fitzgibbon 2005; Fitzgibbon 2006; Harvey-Berino 2003; Jouret 2009; Keller 2009), while environmental change models seemed to inform the design of two of the studies (Mo-Suwan 1998; Reilly 2006).

Resources needed

All studies reported on who delivered the intervention. All interventions were delivered by trained study personnel with the exception of one physical activity intervention which was delivered by two members of staff from each intervention nursery who had attended three training sessions with the study personnel (Reilly 2006). Most studies included information about the length of time for the face-to-face component of the intervention, from which staff hours could be extrapolated, however, five studies provided more specific information about resources required for implementation (Dennison 2004; Fitzgibbon 2005; Fitzgibbon 2006; Harvey-Berino 2003; Reilly 2006). Four of these studies described the materials used to deliver the intervention, for example, materials required to teach particular lesson topics within the classroom setting or resources that were sent home with children, or both. Dennison 2004 mentioned examples of additional community resources that could be mobilised to enhance the intervention. Harvey-Berino 2003 included staff hours required for training in order to deliver the intervention. While no studies included a formal economic evaluation, Reilly 2006 reported estimated costs of both the nursery-based and home-based component of their intervention. The nursery element of the intervention was intended to be inexpensive and therefore generalisable (capital cost < £200, €297, USD377). For the home-based component, each participating family received a resource pack of materials costing £16 (€24, $30) (Reilly 2006). The cost of maintaining the usual curriculum in the control group was not estimated.

Strategies to address disadvantage/diversity

Of the eight studies targeted towards the 0-5 year age group, three incorporated strategies to address disadvantage or diversity (Fitzgibbon 2005; Fitzgibbon 2006; Harvey-Berino 2003). Harvey-Berino 2003 conducted a pilot study targeting mother-child pairs within a Native-American community. Study personnel delivering the intervention received training from a family therapist/parenting consultant from the tribe within which the intervention was delivered. Hip Hop to Health Jr was a combined dietary and physical activity intervention targeted towards preschool minority children, with one study to be conducted in sites which serviced primarily African American communities (Fitzgibbon 2005) and a repeat study conducted in sites which service primarily Latino communities (Fitzgibbon 2006). For the Latino communities, this intervention was delivered in both English and Spanish. In reporting the design of Hip Hop to Health Jr, a number of components have been highlighted as important considerations for any culturally-specific intervention including: safe and easy access to the programme; fostering identification between interventionists and participants; addressing cognitive and environmental barriers to exercise and adoption of a healthier diet; emphasis on behavioural demonstrations to facilitate lifestyle changes and consideration for all levels of literacy (Fitzgibbon 2005).

Process evaluation

Attempts were made to capture programme reach (i.e. to all the target population), programme acceptability (to the target population) and programme integrity (i.e. programme implemented as planned). A comprehensive process evaluation allows variability in context and delivery to be monitored, and the identification of barriers and facilitators to implementation. These factors can then be related to the variability in intervention impact and programme outcomes.

Of the eight studies targeted towards children between the ages of 0 and 5 years, half of them reported some elements that might be considered part of a process evaluation (Fitzgibbon 2005; Fitzgibbon 2006; Harvey-Berino 2003; Reilly 2006). All four of these studies recorded either hours of attendance of participants or number of sessions completed to provide some confidence about the actual dose delivered. Two studies were based on one design that was conducted twice, once in sites servicing primarily African American communities and repeated in sites servicing primarily Latino communities (Fitzgibbon 2005; Fitzgibbon 2006). Fitzgibbon 2005 described the development of their intervention in significant detail which involved an initial pilot to explore feasibility and acceptability. This report provided information about optimal class length, children’s ability to grasp the curriculum and reasons for poor attendance of parents, all of which could be used to adapt their intervention accordingly.

Section 2: six to12 year olds

Effectiveness

Results for outcomes measured in each study for this age group are presented in Table 3. Of the 39 intervention studies targeted towards children between the ages of six and 12 years, 27 studies provided appropriate BMI or zBMI data for inclusion in the meta-analysis. Of those included in the meta-analysis, a statistically significant mean effect size of -0.15 (95% CI: -0.23 to -0.08) was found (see Analysis 1.1), although the heterogeneity of the studies, and small sample sizes of several studies are both limitations, meaning inferences should be made with caution. Analysing only those interventions conducted solely in an education setting did not reduce heterogeneity and resulted in a similar effect size as the whole group (-0.17, 95% CI: -0.25 to -0.09; P < 0.001). Conversely, analysing those studies conducted either in multiple settings (n = 4 of 27 studies), or outside education settings (e.g. home, community) (n = 3 of 27 studies) reduced heterogeneity and resulted in a non-significant mean effect size of -0.07 (-0.24 to 0.10), although the majority of these were small studies. Of those studies not included in the meta-analysis due to the lack of appropriate data being reported, Sahota 2001 reported a weighted mean difference in zBMI between groups from baseline to follow-up of 0 (-0.1 to 0.1). The majority of the other studies reported changes in prevalence of overweight or obesity or percentage body fat and in some cases a significant intervention effect was observed overall or in subgroups (Foster 2008; Gortmaker 1999a; Müller 2001; described below), while non-significant differences were reported in other studies (Fernandes 2009; Kipping 2008; Warren 2003). In total, only seven of the 39 studies were conducted outside of an education setting (Baranowski 2003; Beech 2003; Epstein 2001; Macias-Cervantes 2009; Robinson 2003; Rodearmel 2006; Stolley 1997).

Outcomes from individual studies

Adiposity

Eighteen of the 39 studies targeting this age group reported a significant intervention effect on any measure of adiposity. Thirteen studies reported intervention effects on continuous measures of adiposity (BMI, zBMI, weight, skinfold thickness, percentage body fat, or BMI percentiles) and five studies reported intervention effects on only categorical measures of fatness (weight status e.g. overweight). The effective interventions are summarised below in chronological order.

Gortmaker 1999a reported that after the long-term Planet Health intervention the prevalence of obesity among females in intervention schools was reduced compared with controls, however, there were no differences in male participants.  There was also greater remission of obesity among intervention females compared with control females. Müller 2001 reported a significantly smaller increase in triceps skinfold in the intervention group after the 12-month intervention period. In addition, there were positive intervention effects on percentage fat mass of overweight children (increased by 3.6% per year versus 0.4% per year in control and intervention groups, respectively). In the study by Kain 2004, the only measure of fatness that was decreased significantly in intervention group was waist circumference (reduced by a mean of 0.9 cm in the intervention group and increased in controls by same amount). In the study by James 2004, there were no differences between intervention and control groups in change in BMI from baseline after the 12-month intervention, however, there was a significant difference in the change from baseline in the prevalence of overweight and obesity in favour of the intervention group (increased by 7.5% in the control clusters, and decreased by 0.2% in intervention clusters). This difference was not maintained after three years from baseline. Coleman 2005 explored the effects of the El Paso CATCH programme in schools and found that, although the percentage of children who were at risk of overweight, or overweight did not significantly differ from year to year between intervention and control schools, the rates of increase were higher in control schools. Rates of increase from 3rd to 5th grades were 13% in girls and 9% in boys in control schools, compared with 2% in girls and 1% in boys in intervention schools.

Rodearmel 2006 reported significant differences between intervention and control groups after the 13-week intervention in the mean change of all measures of child fatness (percentage BMI-for-age, percentage body fat) and parent adiposity (weight, BMI and percentage body fat). Given the short-term nature of the intervention, and time between measurements (13 weeks), this effect may be spurious. The five to six-month intervention by Spiegel 2006 was associated with a reduced BMI in the intervention group and a correlation between the change in BMI from baseline to post-intervention.  BMI-for-age data showed no significant shift in the comparison group, but a reduction in the intervention group in overweight and at risk for overweight classification, which was most significant in the at risk for overweight (BMI-for-age between 85% to 95%) level. There was a 2% reduction in overweight (BMI > 85% for age and sex) in the intervention group. However, there was a 16% attrition rate in the comparison group (N = 479 matched measures between baseline to post-data) and a 14% attrition rate in the intervention group (N = 534 matched). 

The long-term New Zealand study by Taylor 2008 reported the adjusted mean zBMI score post-intervention as significantly lower in the intervention group compared with control group children after the first year of the study. After two years, mean zBMI score remained significantly lower in children the whole group and in those who were in the intervention for at least one year 1 (n = 389; -0.19 (95%CI: -0.24 to -0.13)) or 2 (n = 256; -0.21 (95%CI: -0.29 to -0.14)) years. Although the risk of being overweight or obese at year-end in intervention compared with the children in the control group (OR 0.55; 95% CI: 0.19 to 1.48) did not achieve statistical significance, children in the intervention group were less likely to be overweight post-intervention, but only in those who were present for the full intervention. During the two years post-intervention, a lower proportion of children in the intervention group became overweight; more intervention children who were overweight at baseline were not overweight at follow-up, a lower proportion of children in the intervention group became overweight, and a higher proportion of children in the intervention group became normal weight, compared with children in the control group.

A French study (Lazaar 2007) reported post-intervention that the intervention group had a significantly higher rate of remission of obesity (to overweight) and less incidence of obesity. Subgroup analysis revealed effects only in female participants, and larger effects of the intervention were observed in obese (compared with non-obese children) regardless of measure. In male participants, The zBMIz score decreased more in the intervention group than the control group. 

Foster 2008 implemented a school nutrition policy-based intervention and found that the unadjusted incidence of overweight was reduced by 50% as a result of the intervention, with a significantly lower percentage of children in the intervention group (7.5%) becoming overweight after two years compared with children in the control schools (15%). The unadjusted incidence of obesity was not different between groups. After controlling for gender, race/ethnicity and age, the adjusted (predicted) odds of becoming overweight during the intervention period (incidence of overweight) were 33% lower for the intervention group (P < 0.05).  There were no differences in the incidence of obesity.   When collapsing the overweight and obese categories, the predicted odds of incidence of overweight/obesity (becoming overweight or obese during the study period) were 15% lower for the intervention group (P < 0.05). In relation to the prevalence of overweight, after controlling for age, race/ethnicity, gender and prevalence at baseline the predicted odds of being overweight post-intervention (overweight prevalence) were 35% lower in the intervention group post-intervention.  In contrast, after two years there were no differences in the prevalence of obesity, or in the prevalence of overweight/obesity combined (although there was a non-significant trend; P = 0.07). The predicted odds of remission of overweight or obesity (moving from being overweight or obese at baseline to not overweight or obese at post-intervention assessment) were 32% higher for the intervention group (P 0.01). 

Gutin 2008 (The Medical College of Georgia Fitkid Project) reported various results. When using intention-to-treat analysis there were no significant differences between groups, but with higher programme attendance there were significantly greater reductions in percent body fat. During the intervention period, the intervention group significantly reduced their body fat during school months, however, this effect was lost during school vacation (after the summer months). Fat-free soft tissue also showed a significant group by time interaction in favour of the intervention (P < 0.01). However, BMI increased significantly more in the intervention group by the end of the three intervention periods. 

The Australian study reported by Salmon 2008 tested three interventions, and found significant reductions in BMI immediately after the six-month intervention in the Behaviour Modification and Fundamental Movement Skills (BM/FMS) group only compared with control. This effect was maintained at six and 12 months follow-up. This reduction was not observed in with the BM or FMS alone intervention groups.  Also, those in the BM/FMS intervention group were > 60% less likely to be overweight or obese on average between baseline and post intervention and over the four time points of the study compared with control (P <0.05). This effect was maintained at six- and 12- month follow-up. Another Australian study, reported by Sanigorski 2008 found that the three year 'Be Active Eat Well' intervention was associated with significantly smaller increases in weight, waist circumference, waist-to-height ratio and zBMI in the intervention group, compared with children in the control group. 

Sichieri 2009 reported no significant differences between intervention and control groups in BMI or weight as a result of the intervention conducted in Brazil, however, subgroup analysis revealed that for participants overweight at baseline, the intervention group had a greater BMI reduction than the control group, although this difference was only statistically significant among girls. It should be acknowledged that these subgroup findings could be spurious as they were likely to be derived from the data post-hoc and involve relatively small sample sizes, so should be interpreted with caution.

The long-term French study by Simon 2008 reported that post-intervention participants had a smaller increase in BMI (P - 0.01) over time than those in the control group. The significant differences in change in BMI between groups were evident at three years and at four years. The cumulative incidence of overweight was also lower in the intervention group than in the control group at four years.

Vizcaino 2008 reported the Spanish intervention resulted in a significant reduction in triceps skinfold thickness in intervention children compared with controls for both boys and girls. There was also a significant reduction in percentage body fat in girls but not boys, compared with the comparison group.

The long-term study by Donnelly 2009 reported various results. Using intention-to-treat analysis showed no intervention effect on BMI, however analysis of schools (n = 9) with > 75mins of the PAAC intervention activities delivered per week showed significantly less increase in BMI at three years compared to schools (n = 5) with < 75min/week. Marcus 2009 reported that the four-year Swedish intervention was associated with a reduction in the prevalence of overweight/obesity by 3.2% in intervention schools compared with an increase of 2.8% in control schools (P < 0.05). There was also a higher rate of remission of overweight children to healthy weight in the intervention group (14%) compared with the control group (7.5%). 

Summary: Of the 39 studies that targeted children aged six to 12 years, 18 were effective on some indicator of adiposity. Ten studies involved long-term intervention periods (> 12 months), one had an intervention period of 12 months, five had intervention periods approximately six months, and two involved very short-term intervention periods. Seven studies were conducted in the USA, two in Australia, two in France, one in each of New Zealand, UK, Germany, Sweden, Chile, Brazil and Spain. Of the 21 studies not effective on any indicator of adiposity, only three studies had an intervention period greater than 12 months (> one to two years: Sallis 1993; Warren 2003; > two years: Caballero 2003). 

Behaviours

As seen in Table 1, of the 39 studies, six studies targeted dietary factors only, 21 targeted diet and physical activity related factors combined and 12 targeted factors related to promoting physical activity only. On balance, a variety of modest behavioural impacts have been achieved in most of the interventions in this age group. 

Diet-related

Diet-related factors were significantly positively altered in 20 studies. A variety of indicators have been used, however, nutrition knowledge was increased in four studies (Amaro 2006; Müller 2001; Sahota 2001; Story 2003a), eating practices were improved in one study (Robinson 2003), food preparation practices were improved in two studies (Beech 2003; Story 2003a), higher levels of fruit and vegetable consumption was reported in five studies (Amaro 2006; Gentile 2009; Gortmaker 1999a; Hamelink-Basteen 2008; Müller 2001), reductions in energy dense snack foods in one study (Fernandes 2009), reduced intake of sweetened/carbonated drinks in five studies (Beech 2003; Hamelink-Basteen 2008; James 2004; Marcus 2009; Sichieri 2009), reduced intake of sweet foods  was reported in two studies (Hamelink-Basteen 2008; Marcus 2009), reduction in total energy, energy from fat or total fat intake were reported in five studies (Caballero 2003; Gortmaker 1999a; Paineau 2008; Stolley 1997; Story 2003a) and other indicators of better diets were reported in four studies (Fernandes 2009; Marcus 2009; Müller 2001; Rodearmel 2006). 

Physical activity-related

Physical activity-related factors were significantly positively impacted in 21 studies, with a variety of indicators and measures used. Higher levels of physical activity self-efficacy were reported in four studies (Caballero 2003; Harrison 2006; Salmon 2008; Simon 2008), better cardiovascular fitness in three studies (Gutin 2008; Kain 2004; Reed 2008), higher levels of physical activity in nine studies (Hamelink-Basteen 2008, Harrison 2006; Pangrazi 2003; Donnelly 2009, Müller 2001; Rodearmel 2006; Salmon 2008; Spiegel 2006; Taylor 2008), more time spent in organised physical activity in one study (Simon 2008), and decreased sedentary behaviours (predominantly screen time, and television viewing) were reported in eight studies (Foster 2008; Gentile 2009; Gortmaker 1999a; Hamelink-Basteen 2008; Müller 2001; Robinson 2003; Simon 2008; Taylor 2008). 

Cardiovascular disease risk factors

Only eight studies reported the impact of the interventions on cardiovascular disease risk factors other than adiposity. Significant beneficial effects on blood pressure, heart rate, blood lipids, and cardiovascular fitness were reported in four studies (Gutin 2008; Reed 2008; Simon 2008; Vizcaino 2008).

Assessment of outcomes by gender

Nineteen studies analysed the effects of the intervention by gender. Of those, eight reported no difference in outcomes by gender (Caballero 2003; Coleman 2005; Donnelly 2009; Epstein 2001; Foster 2008; James 2004; Sallis 1993; Simon 2008), four reported more pronounced intervention effects in male participants (Kain 2004, Kipping 2008; Marcus 2009; Salmon 2008) and seven reported more pronounced intervention effects in female participants (Gentile 2009; Gortmaker 1999a; Lazaar 2007; Pangrazi 2003; Rodearmel 2006; Sichieri 2009; Vizcaino 2008). Of the studies that did not undertake this analysis, five were female-only studies (Baranowski 2003; Beech 2003; Robbins 2006; Robinson 2003; Story 2003a).

Maintenance/Sustainability of effects

The sustainability of these effects on behaviours was assessed in only four studies (Donnelly 2009; Gentile 2009; James 2004; Salmon 2008). Gentile 2009 reported a significantly lower level of parent-reported TV/computer screen time post-intervention in the intervention group and this effect was maintained at six months follow-up (a reduction of about two hours/week). The intervention group also had a significant increase in parent- and child-reported fruit and vegetable consumption immediately post-intervention and this was also maintained at the six-month follow-up. Salmon 2008 reported that all impacts achieved post-intervention (increased level of physical activity and physical activity-related self efficacy) were maintained six and 12 months post-intervention.  Donnelly 2009 reported on the ‘Physical Activity Across the Curriculum’ intervention which promoted 90 min/wk of moderate to vigorous intensity physically active academic lessons delivered by classroom teachers. Teachers were surveyed nine months after the completion of the intervention and it was found that approximately 95% of teachers were using PAAC lessons on at least one day/week, approximately 55% of teachers indicated that they were using PAAC two to four days/week, ∼35% were using PAAC on most days or every day. James 2004 observed a significant difference in favour of the intervention group in the proportion of children who were overweight or obese following a 12-month intervention aimed at encouraging a healthy diet and reducing carbonated drink consumption, however this difference was not maintained at two years after the intervention had ended.

Equity

With the exception of Robbins 2006, all studies reported one or more items of the PROGRESS framework at baseline. Most studies reported gender of participants at baseline (n = 32). Socio-economic status (SES) (n = 16) and race (n = 15) were the next most commonly reported items at baseline, followed by education level of parents (n = 11), place (n = 6), occupation or employment status of parents (n = 4) and social status (n = 2). When analysing outcome data, 17 studies did not analyse by any of the items in the PROGRESS framework. Of the 22 studies that did analyse by at least one item on the PROGRESS framework, the majority analysed outcomes by gender (n = 21). A total of six studies included analysis of outcome data by PROGRESS items other than gender (Foster 2008; Gortmaker 1999a; Gutin 2008; Marcus 2009; Sanigorski 2008; Simon 2008). These included race (n = 3), SES (n = 3) and education level of parents (n = 2).

Foster 2008 used subgroup analysis (by participant ethnicity) to determine that in addition to the main effect of the intervention on the prevalence of overweight and obesity, the intervention’s effect on the prevalence of overweight was particularly effective for African American participants (OR: 0.59; 95% CI: 0.38 to 0.92; P < 0 .05), after the two-year intervention, with control for gender, age, and baseline prevalence.  Overall, after controlling for gender, race/ethnicity, age, and baseline prevalence, the predicted odds of overweight prevalence were 35% lower for the intervention group (OR: 0.65; 95% CI: 0.54 to 0.79; P < 0.0001).  There were no interaction effects between the intervention and race/ethnicity, gender, or age on the level of inactivity or television viewing. 

Gortmaker 1999a analysed the impacts of the Planet Health intervention on changes in obesity by ethnic group. The largest intervention effects were observed in African American girls, with obesity prevalence significantly reduced in intervention (n = 28) versus control (n = 51) participants (OR 0.14; 95% CI: 0.04-0.48; P = 0.007). Among white girls (intervention n = 223; control n = 200), the intervention effect was similar to the overall result (OR 0.46; 95% CI: 0.19-1.12; P = 0.08), while for Hispanic girls (intervention n = 31; control n = 48), results did not reach statistical significance (OR, 0.38; 95% CI: 0.03-5.3; P=0.42). The findings in African American girls and Hispanic girls should be treated with caution due to the small sample size in those groups. No differences were found for boys.

In the Swedish STOP study reported by Marcus 2009, a significant interaction effect was observed between parental education level and the impact of the intervention on reported intake of dairy products and fast food. For children in families with low parental education background, the odds ratio (OR) was 3.58 for healthy choice behaviour for dairy products in the intervention group compared with the control group (OR = 1.0), whereas for children in families with high parental education background the corresponding ORs for the intervention group and the control group were 1.65 and 1.18, respectively (P for interaction = 0.02). A similar pattern was observed for the healthy choice behaviour in relation to fast foods, where ORs were 2.5 in the intervention group compared with 1.0 in the control group in children in families with low parental education, and 2.1 and 3.2 in families with a high parental education, for intervention and control groups, respectively (P for interaction = 0.0005).

Sanigorski 2008 reported a flattening of the gradient between measures of fatness and SES after the intervention period in the intervention group, which was not apparent in the control group.   Associations between the adjusted changes in the five anthropometric measures and the four individual- and area-level indicators of socio-economic status were tested post-intervention.  In the comparison population, all regression coefficients were negative and 19 of 20 analyses were statistically significant (lower SES associated with a greater weight gain). In the intervention group, all coefficients were also negative, but none were statistically significant and the association was less strong than in the comparison group.  

Simon 2008 reported impacts on fatness and physical activity related factors, however they also tested the interaction of outcomes with gender and SES status (based on highest parental occupation category), and found no significant interactions, suggesting no difference in outcomes by these factors. 

Summary: All studies which assessed outcomes by a PROGRESS measure of equity, reported either no association between the outcomes of the intervention and the PROGRESS measure, or positive impacts for groups of lower SES.  The possibility of a bias towards reporting favourable equity effects cannot be excluded.

Harm-adverse/unintended effects

Eight studies assessed adverse or unintended consequences of the interventions.  A variety of measures were used to assess adverse effects, including prevalence of underweight, unhealthy eating practices, teasing, stigmatisation, body image perceptions, satisfaction and self-worth.  In all studies either very few (Beech 2003) or no adverse outcomes were reported (Foster 2008; Gortmaker 1999a; Marcus 2009; Sahota 2001; Salmon 2008; Sanigorski 2008; Story 2003a). Based on the available studies, there is no evidence of adverse effects of obesity prevention interventions in this age group, however it must be acknowledged that only a minority of the 39 studies reported that adverse effects were assessed.

Implementation
Design and theoretical basis

Twenty one of the 39 studies targeted both diet and physical activity. Twelve studies targeted physical activity alone and six studies targeted diet alone. The majority of studies had short intervention periods (< one year; 27 studies). Five studies had an intervention period of one to two years and seven studies had intervention periods of longer than two years.

Of the 39 studies targeting children aged six to 12 years, the theoretical basis of the intervention design was explicitly reported in 24 studies. The predominant theories were behavioural, although a variety of other theories such as environmental change, socio-ecological, social learning theory, health promotion, the Transtheoretical Model and youth development and resiliency based approaches are also represented. In a number of studies, where theories were not reported they could be surmised based on the details provided (see Table 1). 

Process evaluation

Of the 39 studies, 26 reported some elements of process evaluation. Many studies recorded programme attendance or number of sessions completed in order to estimate exposure (Baranowski 2003; Beech 2003; Caballero 2003; Donnelly 2009; Gortmaker 1999a; Gutin 2008; Harrison 2006; Kain 2004; Kipping 2008; Robinson 2003; Sahota 2001; Salmon 2008; Sanigorski 2008; Simon 2008; Stolley 1997; Story 2003a; Vizcaino 2008). In addition to attendance or participation, it is also possible to assess the intensity of intervention delivery. Lazaar 2007 implemented a physical activity intervention and estimated intensity of the exercise sessions by randomly selecting two participants from each intervention group and monitoring their physical activity levels. Donnelly 2009 reported intensity of lesson delivery and also investigated the effect of teacher participation in classroom physical activity. They found that teacher participation appeared to influence student activity levels in the study, so that teachers who were more physically active tended to have students who were more physically active as well.

A related concept measured is adherence to the intervention programme, often assessed from the perspective of those delivering the intervention. Marcus 2009 reported that research staff performed both regular and random compliance checks at participating schools, documenting deviations and discussing them with headmasters in order to address them as the study progressed. Adherence to the programme by participants was also measured in two studies, with physical activity levels monitored to determine if participants were following the intervention guidelines (Macias-Cervantes 2009; Rodearmel 2006).

Many studies also explored satisfaction with the programme from the perspective of either participants or those who delivered the intervention, or both (Beech 2003; Caballero 2003; Coleman 2005; Gortmaker 1999a; Kain 2004; Kipping 2008; Robbins 2006; Robinson 2003; Salmon 2008; Sanigorski 2008; Spiegel 2006; Story 2003a; Vizcaino 2008; Warren 2003). Measures included levels of enjoyment, ease of implementation (barriers and facilitators) and general impressions about the intervention. Information was collected using a variety of methods including surveys, focus groups and interviews. For example, in Kipping 2008, teachers reportedly found it difficult to adhere to the intervention requirements as intervention lessons were difficult to accommodate into the school timetable.  Robbins 2006, similarly identified important barriers to increasing physical activity in some girls, with lack of suitable places, resources and social support for physical activity limiting compliance with the intervention programme.  The process evaluation therefore identified important environmental barriers that need to be addressed to increase the potential for the intervention to be implemented fully. Robinson 2003 also explored barriers to attendance and found transportation to be an important factor. Coleman 2005 published implementation-related information in a separate paper and provided recommendations to practitioners covering some of the contextual factors to consider when adapting the programme to their own context (Heath 2002).

Beyond exposure, barriers to attendance, ease of implementation and satisfaction with the programme, a number of studies employed more sophisticated process evaluation measures to investigate programme fidelity (Donnelly 2009; Gutin 2008; Kain 2004; Reed 2008; Sahota 2001; Salmon 2008; Sanigorski 2008). For example, Gutin 2008 assessed programme fidelity by evaluating programme variability, participant variability and site variability (Yin 2005; Yin 2005a; Yin 2005b). A detailed process evaluation linked to the study by Sanigorski 2008 summarises the results of a number of process measures covering potential impact, barriers encountered and the likely sustainability for each intervention component (Simmons 2008).

Resources needed

All studies reported who delivered the intervention. Approximately half of the interventions were delivered primarily by trained study personnel (Baranowski 2003; Beech 2003; Epstein 2001; James 2004; Kain 2004; Lazaar 2007; Macias-Cervantes 2009; Müller 2001; Robinson 2003; Rodearmel 2006; Sahota 2001; Sallis 1993; Salmon 2008; Sanigorski 2008; Sichieri 2009; Simon 2008; Stolley 1997; Story 2003a, Taylor 2008, Vizcaino 2008; Warren 2003). The remaining interventions were delivered primarily by school-based staff, usually teachers, after receiving training and materials from the study team (Amaro 2006; Caballero 2003; Coleman 2005; Donnelly 2009; Fernandes 2009; Foster 2008; Gentile 2009; Gortmaker 1999a; Gutin 2008; Harrison 2006; Kipping 2008; Marcus 2009; Paineau 2008; Pangrazi 2003; Reed 2008; Robbins 2006; Spiegel 2006). Sallis 1993 included two intervention groups, one led by specialists from the study team and one led by teachers trained by study team.

Twenty-eight of the 39 studies included information about the resources required to deliver the intervention, however the level of detail varied considerably. Many studies included information about the length of time required for the face-to-face intervention components, however some studies also included information about time required for staff training in order to deliver the intervention and/or additional support and consultation offered by study team members (Caballero 2003, Donnelly 2009, Foster 2008, Gutin 2008, Kain 2004, Sahota 2001, Sallis 1993, Sanigorski 2008, Sichieri 2009, Story 2003a; Taylor 2008; Vizcaino 2008). Many studies included descriptions (to varying levels of detail) of the materials used to deliver the intervention, such as lesson topics, materials used within the classroom or sent home with children, curricula and planning guides provided to teachers, resources provided for families, as well as items provided as incentives for participation and achievement (Amaro 2006; Beech 2003; Caballero 2003; Coleman 2005; Epstein 2001; Gortmaker 1999a; Gutin 2008; Harrison 2006; Kain 2004; Kipping 2008; Paineau 2008; Pangrazi 2003; Reed 2008; Robbins 2006; Robinson 2003; Rodearmel 2006; Sahota 2001; Salmon 2008; Sanigorski 2008; Sichieri 2009; Spiegel 2006; Story 2003a; Warren 2003). One study estimated the total number of person-hours required to implement the intervention (Sanigorski 2008) and Müller 2001 reported the availability of intervention materials for purchase by education and counselling services. 

The Medical College of Georgia Fitkid Project (Gutin 2008) published information not only about the rationale, design and components of their physical activity intervention, but also included information about contextual factors that the study authors believe may have been important for implementation within their study setting (Yin 2005). This included assessment of feasibility, based on the facilities available within schools such as indoor and outdoor sporting facilities and play areas, and suitably large classrooms within which to hold academic enrichment sessions. Transportation, funded by the research project, was also provided for study participants, minimising an important barrier to participation in after-school programmes. “Action Schools! BC” evaluated an ‘active school’ model for elementary school-based physical activity promotion (Reed 2008). Reports on this intervention included an implementation model to depict the various intervention components, including materials provided, and support and liaison roles to implement the programme (Naylor 2006; Naylor 2006a).

While no studies included a formal economic evaluation, Kipping 2008 included the cost of materials and teacher training (£110 per teacher and £2 per pupil), Coleman 2005 included the amount of funding provided for evaluation, funding for co-ordinators, facility overhead, copying, incentives, and translation services (USD4.2 million over four years), Vizcaino 2008 reported the cost (28 euros) per child per month and Sanigorski 2008 included the amount of funding provided to implement the intervention (AUD100 000 per year for four years). Intervention costs in the studies mentioned above were not compared with costs in the control groups since these consisted of either no intervention or maintaining usual curriculum/practice. In the studies authored by Kipping 2008 and Vizcaino 2008, costs were reported for the purpose of emphasising feasibility and generalisability with both considering their interventions to be relatively inexpensive and so, from a cost perspective, feasible to scale up.

Strategies to address disadvantage/diversity

Of the 39 studies, 15 incorporated strategies to address disadvantage or diversity. Seven interventions included components tailored for African American children, four of these were part of the GEMS (Girls health Enrichment Multi-site Studies) project, targeting African American girls (Baranowski 2003, Beech 2003, Robinson 2003, Story 2003a). Of these, three specifically targeted low-income participants (Beech 2003, Robinson 2003, Story 2003a), while the fourth included participants of a middle- and upper-income demographic (Baranowski 2003). All four GEMS studies conducted formative evaluation including focus groups, interviews and surveys with African American girls and their families to inform the intervention design. Two of the GEMS studies reported culturally matching providers of lessons, ensuring that interventions were delivered by African American instructors (Robinson 2003, Story 2003a). Robinson 2003 also describes the incorporation of African and African American history and cultural themes into the intervention lessons. Stolley 1997 developed a culturally specific curriculum for African American girls and their mothers that included education about food labels, shopping and food preparation using foods and recipes identified by participants. Culturally relevant music and dance were utilised for a physical activity component and the curriculum was adapted to suit the needs of their inner-city population, for example, ensuring the venue was within walking distance for participants. Gutin 2008 implemented a culturally sensitive physical activity intervention to predominantly African American students.  Strategies used to deliver an a culturally appropriate intervention programme included engaging African American teachers/personnel to implement the programme, an “emphasis on collective goals, interpersonal rather than individualistic influences, and distinctiveness in dress and verbal expressions” were considered when deciding on various aspects of the intervention.

Caballero 2003 targeted a combined dietary and physical activity intervention toward American Indian schoolchildren. Formative research and approval by tribal health authorities were used to ensure culturally appropriate classroom curriculum. Coleman 2005 translated a school health curriculum that had been tested in a national trial into community low-income school settings in an area with a population of predominately Mexican descent, so the curriculum was designed to reflect this. Robbins 2006 described the development of an individually tailored physical activity computer-based intervention which enabled the inclusion of culturally sensitive and developmentally appropriate strategies for participants from diverse ethnic backgrounds. Spiegel 2006 administered survey measures that were available in English and Spanish.

The remaining five studies were conducted in areas of social disadvantage (Harrison 2006; Salmon 2008, Kain 2004), or in a rural setting (Vizcaino 2008, Sanigorski 2008).

Section 3: 13 to 18 year olds

Effectiveness

Results for outcomes measured in each study for this age group are presented in Table 4. Of the eight included studies targeting adolescents, six provided appropriate BMI or zBMI data for inclusion in the meta-analysis (NeumarkSztainer 2003; Ebbeling 2006; Haerens 2006; Webber 2008; Singh 2009; Peralta 2009). Of those included in the meta-analysis a mean standardised difference between change in BMI/zBMI from baseline to post-intervention between intervention and control groups was -0.09 units (95% CI: -0.20 to 0.03) (see Analysis 1.1). Although this was not statistically significant, and the heterogeneity of the studies is a limitation, the results show there was a trend for intervention children to have smaller increases in these measures of adiposity over time. The two studies not included in the meta-analysis (Patrick 2006, Pate 2005) did not report appropriate BMI or zBMI data; however it was reported that the prevalence of overweight or obesity was not different between groups post-intervention in the Pate 2005 study, and it was reported that BMI z scores were not different between groups post-intervention in the Patrick 2006 study, although the subgroup of children with a BMI at or above the 95th percentile tended to have a lower BMI z score (P = 0.10). The small number of studies and observed heterogeneity of the studies in the meta-analysis limits our ability to determine with confidence the effectiveness of interventions in adolescents, although these results are promising. 

Outcomes in individual studies

Adiposity

Of the eight studies included in this subgroup, only Ebbeling 2006 and Singh 2009 reported a significant intervention effect on any measure of adiposity. Many studies had only small sample sizes which limits their power to detect significant changes. Immediately after the eight-month intervention (the DoiT programme), Singh 2009 reported significant reductions in hip circumference (mean difference, 0.53 cm; 95% CI, 0.07 to 0.98) and sum of skinfolds among females (mean difference -2.31 mm; 95% CI, -4.34 to 0.28). In males, the intervention resulted in a significant difference in waist circumference (mean difference, -0.57 cm; 95% CI, -1.10 to -0.05).  A follow-up assessment conducted at 12 and 20 months found no intervention impacts on BMI, however, there were impacts on fatness (measured by skin fold thickness).  Intervention males showed significantly lower triceps (-0.7mm; 95% CI: -1.2 to -0.1 mm), biceps (-0.4 mm; 95% CI: -0.8 to -0.1 mm) and subscapular (-0.5 mm; 95% CI: -1.0 to -0.1 mm) skinfold thickness at 20 months. In female participants there was a significant intervention effect on biceps skinfold thickness (-0.7 mm; 95% CI: -1.3 to -0.04 mm) and the sum of skinfold thickness (-2.0 mm; 95% CI: -3.9 to -0.1 mm) at 20 months. Ebbeling 2006 did not report any overall differences in BMI between intervention and control groups, however there was a significant difference in BMI change in favour of the intervention group among those with baseline BMI > 30 kg/m2 (-0.63 ±- 0.23 kg/m2 versus +0.12 ± 0.26 kg/m2).

Behaviours

On balance, a variety of modest behavioural impacts have been achieved from the interventions in this age group. 

Diet-related

Although a number of dietary behaviours were targeted by all but two interventions, and a range of measures of dietary intake were utilised, significant positive dietary changes were reported in only three studies.  The two-year Belgium study of Haerens 2006 reported a significantly lower intake of fat and percentage of energy from fat in intervention children compared with the control group. Ebbeling 2006 reported a significantly greater decrease in energy intake from sugar-sweetened beverages along with an increase in noncaloric beverage intake in intervention participants compared with control participants. Singh 2009 also reported significant positive impacts of the intervention on consumption of sugar-sweetened beverages, soft drinks, and fruit juices.  These positive intervention impacts were sustained at the 12-month follow-up assessment (four months post-intervention), but had dissipated at the 20-month follow-up assessment. Patrick 2006, while not finding an overall intervention effect, did observe that more females in the intervention group met the guideline for maximum percentage of daily calories from saturated fat at 12 months.

Physical Activity-related

Physical activity-related behaviours were measured in all studies, and five studies report at least one indicator of significant positive intervention impacts on physical activity.  After one full academic year of the LEAP (Lifestyle Education for Activity programme) intervention, Pate 2005 report that 45% of girls in the intervention schools and 36% of girls in the control schools reported vigorous physical activity during an average of one or more 30-minute time blocks per day over a three-day period (P = 0.05). When missing data at follow-up were imputed by applying a regression method, this prevalence difference increased in statistical significance (P < 0.05). This rigorous study reported that a school-based intervention can increase regular participation in vigorous physical activity among high-school girls however the short time frame (< 12 months) may have limited the impact of this intervention given the approach taken (socio-ecological model).  The study by Haerens 2006 reported that in males, the intervention significantly increased school-related physical activity, reduced the decrease in light intensity physical activity and stabilised time in moderate-to-vigorous physical activity compared with changes in the control group (Haerens 2006).  In females, the intervention reduced the decrease in light intensity physical activity.  Peralta 2009 found that after the six-month intervention period, intervention males had significantly less weekend vigorous physical activity than comparison males. Patrick 2006 found that boys in the intervention group increased their number of active days per week compared with boys in the control group, however this effect was not observed in girls. During a three-year intervention in girls, Webber 2008 found no intervention impacts on physical activity at two years, however at three years, girls in intervention schools had 10.9 more MET-weighted minutes of moderate-vigorous physical activity (MVPA) than those in control schools. The same study also found a smaller decrease in physical activity from 6th grade to 8th grade in girls from intervention schools compared with those from control schools. There was a differential effect by ethnicity in this study, with higher physical activity levels reported for white girls compared with African American girls or Hispanic girls at both two years and three years.

Sedentary-related

Only one study reported positive intervention impacts on sedentary behaviours, with Patrick 2006 observing a change in sedentary behaviours in favour of the intervention group compared with control (changes from baseline to endpoint: 4.3 ± 3.4 to 3.4 ± 2.6 h/d vs 4.2 ± 3.4 to 4.4 ± 3.7 h/d for girls, [P =. 001]; 4.2 ± 3.7 to 3.2 ± 2.6 h/d versus 4.2 ± 2.8 to 4.3 ± 3.5 h/d for boys, [P =. 001]). This corresponds to a percentage change for intervention versus control of -21% versus + 4.8% in girls and -24% versus + 2.4% in boys To measure this, participants completed a self-report measure of recent school day and non-school day time spent watching television, playing computer/video games, sitting talking on the telephone, and sitting listening to music. A composite score of sedentary behaviour was calculated from a weighted sum of the school day and non-school day responses.

Cardiovascular disease risk factors

No studies measured the impact of the interventions on cardiovascular disease risk factors other than adiposity.

Assessment of outcomes by gender

Of the eight studies in this section, three were conducted with female participants only (NeumarkSztainer 2003; Pate 2005; Webber 2008) and one was conducted with male participants only (Peralta 2009). The remaining four studies included both males and females and examined differences in outcomes by gender (Ebbeling 2006; Haerens 2006; Patrick 2006; Singh 2009).  Ebbeling 2006 found no significant differences in outcomes between males and females. While observing no gender differences in most outcomes, Patrick 2006 reported one dietary measure and one physical activity measure where there were gender-specific differences in favour of the intervention group for females and males respectively. Haerens 2006 reported different intervention impacts between male and female participants, with the intervention seeming to bring about more activity-related changes in males (no impact on diet), and more dietary related impacts in females, although some impacts on physical activity were also observed for females. Haerens 2006 also reported that for females in the intervention with parental support group, there was a smaller increase in BMI compared with the control group after two years, an effect not observed for males in the equivalent group. This gender difference was not present in the group receiving intervention alone (without parental support). Immediately after an eight-month intervention (the DoiT programme), Singh 2009 reported significant reductions in hip circumference and sum of skinfolds among females. In males, the intervention resulted in a significant difference in waist circumference. At 20 months, intervention males showed significantly lower triceps, biceps and subscapular skinfold thickness, while in female participants there was a significant intervention effect on biceps skinfold thickness and the sum of skinfold thickness. Given the limited evidence, there is no clear picture of how gender may influence effectiveness of the interventions in adolescents. 

Maintenance / Sustainability of effects

Post-intervention follow-up was reported for two studies (NeumarkSztainer 2003, Singh 2009).  Follow-up data from the Singh 2009 study are reported above.  A follow-up assessment was also performed in the NeumarkSztainer 2003 study, eight months after the end of the 16-week intervention and eight-week maintenance periods.  For the majority of outcome variables, differences between intervention and control schools post-intervention and at follow-up were not statistically significant, except change in Physical Activity Stage, which was significantly increased in the intervention group at follow-up, compared with control children.

In summary, although obesity-related behaviours were not different at the end of the follow-up periods of either study, the Singh 2009 study, with an eight-month intervention period, was associated with reduced body fatness in adolescents even 12 months post-intervention, with the largest effects observed in female participants.

Equity

All studies reported at least one item from the PROGRESS framework at baseline. Most studies reported gender (Ebbeling 2006; Haerens 2006; NeumarkSztainer 2003; Peralta 2009; Singh 2009) and/or race (Ebbeling 2006; Pate 2005; NeumarkSztainer 2003; Patrick 2006; Singh 2009; Webber 2008) of participants. Two studies included information about the socio-economic status of participants (Ebbeling 2006; Haerens 2006), and one study included information about the highest household education level (Patrick 2006). When analysing outcome data, only four of the eight studies analysed results by any of the PROGRESS items. Four studies analysed results by gender (Ebbeling 2006; Haerens 2006; Patrick 2006; Singh 2009; for results refer to section on gender above) and two studies by race (Pate 2005; Webber 2008). Webber 2008 found a differential effect by race, with higher physical activity levels reported for white girls compared with African American girls or Hispanic girls at both two years and three years after baseline. Singh 2009 analysed results by both gender (results reported above) and race and, although the data for race was not provided, it was reported that there was no group by ethnicity interaction (Singh 2009). The lack of analysis by a measure of equity or socio-economic status limits our ability to assess the effectiveness of the interventions in reducing health inequities, however it should be noted that most of the studies targeted settings or families of low socio-economic status. The studies in this age group were conducted in four different countries (USA (five studies), Belgium, Netherlands and Australia) allowing us to assess the utility of the approaches in a variety of contexts. 

Harm-adverse/unintended effects

It is critical that measures of harm or unintended consequences are included in evaluations targeting eating and activity related behaviours, to ensure that interventions are safe and appropriate.  This is particularly important in adolescents, where body image sensitivities are wide spread and there is the real possibility of causing unintended consequences such as stigmatisation, low self-esteem or unhealthy dieting practices.  This is also particularly important in short-term studies and the implications of any impacts on diet, weight and fatness should be carefully considered.  None of the eight studies targeting adolescents explicitly reported unintended outcomes or measures of harm, however, NeumarkSztainer 2003 reported measures of unhealthy weight control, self-acceptance and self-worth, which were not different between groups immediately after the New Moves intervention or at the eight-month follow-up assessment.

Implementation
Intervention design and theoretical basis

Five of eight studies targeted both diet and physical activity. Pate 2005 and Webber 2008 targeted physical activity alone, while Ebbeling 2006 targeted diet alone.   All but two studies had short intervention periods (< 1 year), with Haerens 2006 having an intervention period of two school years and Webber 2008 including a two-year staff-directed intervention followed by one-year Programme Champion component.

Of the eight study designs, theoretical basis was reported in all but one (Ebbeling 2006).  A range of behaviour change theories informed the design of five of the studies (Haerens 2006; NeumarkSztainer 2003; Patrick 2006; Peralta 2009; Singh 2009), while a socio-ecological framework was used by Pate 2005, Webber 2008 and possibly also Singh 2009.

Process evaluation

Of the eight studies targeting children aged 13 to 18 years, six studies reported some elements of process evaluation (Ebbeling 2006; Haerens 2006; NeumarkSztainer 2003; Peralta 2009; Singh 2009; Webber 2008). These studies recorded programme attendance and/or adherence to instructions by participants . These are measures of dose delivered or exposure to the intervention. Haerens 2006 also reported a working group meeting at regular intervals to evaluate implementation of their intervention, and reported that BMI z-score increased significantly more in schools with low levels of implementation, when compared with schools with medium and high levels of implementation. Four studies planned a more detailed process evaluation into their measures for their intervention. These included measures of intervention fidelity, feasibility of implementation, satisfaction and acceptability for participants and relevant stakeholders and suggestions for programme modification (NeumarkSztainer 2003; Peralta 2009, Singh 2009; Webber 2008).

Resources needed

All studies reported on who delivered the intervention. The majority of the interventions were delivered by school staff with varying levels of support from research staff, usually involving training, materials and consultation as needed (Haerens 2006, NeumarkSztainer 2003; Pate 2005, Peralta 2009, Singh 2009; Webber 2008). Singh 2009 implemented an intervention that included a classroom-based component, delivered by regular teachers, as well as an environmental intervention at the school level, facilitated by the research team. Ebbeling 2006 and Patrick 2006 both delivered home-based intervention provided by research staff. Five of the eight studies provided varying levels of information about resources required for implementation. Singh 2009 provided a list of tools and materials for each of their intervention components. Haerens 2006 detailed sports equipment provided to schools, in addition to educational materials for teachers and students. NeumarkSztainer 2003 provided a detailed description of intervention activities including information on resources and staff training. Links with the community were also utilised with community guest instructors facilitating some of the physical activity sessions. Webber 2008 included information about linking school and community agencies to develop programmes as well as the cost of providing a stipend for a Programme Champion. No studies included a formal economic evaluation, however, Ebbeling 2006 estimated that the costs involved in delivering their intervention was approximately 35 USD per student over 25 weeks.

Strategies to address disadvantage/diversity

Of the eight studies only one incorporated strategies to address disadvantage or diversity. Singh 2009 targeted adolescents with lower socio-economic and educational level. Pre-testing of the materials allowed the research team to adapt workbooks and worksheets that was appropriate,  easy to understand and included practical assignments over theoretical assignments (Singh 2009).

Discussion

Summary of main results

This updated review now includes 55 studies of programmes aimed at preventing obesity in children aged 0 to 18 years, and across the age range we present evidence indicating that childhood obesity prevention may be effective at reducing adiposity in children.  The best estimate of effect on BMI was of a 0.15kg/m2 reduction which would correspond to a small but clinically important shift in population BMI if sustained over several years. However, the unexplained heterogeneity of effects observed, potential attrition bias in many studies, and the likelihood of small study bias may have inflated our estimate of effect, so these findings should be interpreted with caution. The majority of the included studies targeted children aged six to12 years, with interventions predominantly based on behaviour change theories and implemented in education settings. Further, analysis by age group indicates the strongest evidence of effectiveness is in six to 12 year olds (primarily due to the larger number of studies in this age group), with promising findings also in 0-5 year olds, particularly for interventions conducted in home or healthcare settings.  The interventions were developed to prevent obesity through strategies aimed at altering dietary or physical activity related factors, or both combined.  These types of interventions represent only some of the factors that are important in tackling childhood obesity and should be considered as part of a suite of interventions including population and targeted measures with action across a range of areas that may include advertising, obesogenic environments and government and school policy (Foresight 2007). The variety of approaches used in the interventions in this review, combined with heterogeneous measures used to assess intervention impacts, limits our ability to draw firm conclusions about the best interventions for effective behaviour change.  Further, although a variety of positive intervention impacts were reported on behavioural measures, only a limited number of studies reported post-intervention follow-up, which makes it difficult for us to have confidence that the outcomes of often short-term interventions are sustained over the longer term.  Despite this, the interventions which report on potential adverse effects and outcomes by indicators of equity provide evidence that childhood obesity prevention interventions can be both safe and equitable. 

Effectiveness

Our review includes a meta-analysis of 37 studies with a combined sample of 27,946 children.  This analysis reveals these interventions may be effective in reducing the magnitude of the change in BMI/zBMI from pre- to post-intervention by -0.15 units, relative to the change in the control group. Subgroup analysis by age group revealed that the effectiveness of interventions in young children and adolescents is less clear, and more studies in these age groups are needed. The analysis in children age six to 12 years includes the majority of the studies and provides the clearest indication that obesity prevention interventions can be effective at reducing adiposity.

In an attempt to examine the clinical significance of the effect size seen, we have applied these to the BMI of an average Australian child of preschool, elementary school and secondary school age.  For a preschool child aged 3.7 years with a BMI 16.3 kg/m2, an effect size of -0.26 would represent reducing average BMI by 1.6%.  For a child aged 9.5 years with a BMI 18.2 kg/m2, an effect size of -0.15 would represent reducing average BMI by 0.8%.  For a child aged 14 years with a BMI 16.3 kg/m2, an effect size of -0.09 would represent reducing average BMI by 0.4%.

While these effect sizes may appear small they represent important reductions at a population level if sustained over several years.  A study of Australian adults shows that a 1.4kg/m2 increase in BMI in men and 2.1 kg/m2 increase in BMI in women over a 20 year period (1980-2000; average increase of 0.07-0.105 kg/m2 per year) was associated with a doubling of the population prevalence of obesity, and a four-fold increase in the prevalence of obesity class III (BMI≥40 kg/m2) Walls 2009.  The effect sizes seen in the meta-analysis across all groups are comparable (-0.09) or larger (-0.15 and -0.26) then the increases which were associated with these substantial increases in obesity prevalence. 

In addition, it should be noted that these effect sizes were demonstrated with predominantly non-overweight children, and in trials of prevention interventions-rather than treatment interventions, and with children, over mainly short (≤12 months) intervention periods.  As such we would expect small effect sizes. 

Although the sample size for the meta-analysis is large, 18 studies were not able to be included. This was due to a lack of appropriate BMI data reported, and is a limitation given the intended purpose of the review to reflect the findings on effectiveness across the evidence base. Of those not included in the meta-analysis, six studies reported significant intervention impacts on the incidence, remission or prevalence of overweight or obesity (Coleman 2005; Gortmaker 1999a; Jouret 2009; Müller 2001; Rodearmel 2006; Salmon 2008). The other studies did not report significant intervention impacts on any indicator of adiposity. When reviewing the evidence, it is apparent that many individual studies are underpowered to detect small differences between groups, particularly on adiposity outcomes. We did not exclude studies from the meta-analysis for any other reason apart from the data not being available. Some may view this as a limitation since studies of varying quality were inevitably included. However, given the heterogeneity in the designs of included studies as well as the variability in reporting, it was not feasible to define a clear quality threshold for studies to meet in order to be included. Including all studies that reported BMI data was determined to be the most transparent way to present the findings of this review. Further, the funnel plot suggests there is evidence of the under-reporting of small studies with negative findings in the published literature, which may inflate our assessments of effectiveness.

Applicability of the evidence

This review included studies from high income countries as well as lower-middle- and upper-middle-income countries, with five studies conducted in countries within the latter two groupings (Thailand, Brazil, Chile and Mexico). This means that, while predominantly conducted within high-income settings, the findings from this review may be generalisable to a number of settings. A total of nineteen studies specifically reported incorporating strategies to target socio-economic and/or cultural diversity or disadvantage. One such study was conducted outside of the high-income country setting, in Chile, an upper-middle-income country. Of the remaining eighteen studies, seven studies conducted in the USA were of interventions targeting African American children and their communities and another two studies targeted Native American communities. Other studies targeted participants of low socio-economic status, or were implemented in areas of social disadvantage. By far the most common setting for interventions included in this review were schools (43 studies). Other interventions were (or included) home-based (14 studies), community-based (six studies), or were set in a health service (two studies) or care setting (two studies). Eleven studies incorporated interventions across multiple settings. Most interventions took a combined dietary and physical activity approach to obesity prevention (31 studies). As a single strategy, targeting physical activity alone was more popular (17 studies) than targeting diet alone (seven studies). The predominant theoretical basis for interventions in this review was behaviour change theory. Other theories represented include environmental change strategies, the socio-ecological framework, social learning theory, health promotion theory, transtheoretical models, and youth development and resiliency based approaches. The theoretical basis for interventions was explicitly reported in approximately half of the included studies.

Quality of the evidence

Where reporting was sufficient, the overall quality of studies in this review was reasonable as assessed by The Cochrane Collaboration's 'Risk of bias' tool. Many studies were assessed as having a low risk of bias across a number of domains. This review includes non-randomised studies, meaning that selection bias is a potential concern. However, many of the non-randomised studies in this review sought to minimise the impact of potential selection bias. Contamination is another important consideration for the interventions studied in this review. While some studies acknowledged the susceptibility of their findings to this issue, most studies mentioned recruiting groups in different locations to minimise this, and of note, the majority of studies in this review were cluster RCTs. It is important to acknowledge that some cluster RCTs did not report addressing unit of analysis issues, despite randomising at a cluster level and analysing outcomes at the individual level. The validity of outcome measures continues to be an important consideration for this evidence base, given the variety of tools utilised. While many studies reported the validity of their measurement tools, many studies did not. Also, many studies included measures of behaviour change relying on self-report, which can lead to estimates that are less accurate. However, all studies in this review included an objective measure of adiposity such as BMI, waist circumference or percentage body fat. Having an objective measure increases the potential to limit the impact of outcome assessors not being blinded.. Most studies included clear reporting of participant flow through the study, describing the extent of missing data, with some studies attempting to analyse the potential impact of missing data on their outcomes and providing information about the characteristics of participants that did not complete post-intervention assessments. Importantly, many papers provided insufficient information to make an informed judgement about the risk of bias, highlighting the need for more careful reporting of research methods. Informed decisions based on research evidence rely on comprehensive and transparent reporting. Publishing complete study protocols will increase the level of comprehensive reporting in obesity prevention research. This will make it easier for readers to assess whether a study has measured and reported all outcomes as intended in the study protocol, which is an important consideration in assessing the risk of bias of a study.

What is new in this review?

This review update includes 36 new studies. To provide useful evidence to decision makers, and those wishing to replicate effective interventions, we have attempted to provide a synthesis of a variety of “implementation factors”.  We believe this information is required to move beyond simply the question of what works in obesity prevention, to the other important questions of how it worked, will it work in another context or under different conditions, and is it feasible or appropriate for others to implement.  Although we have summarised available evidence from the included studies in this review, often the detail required to answer these questions is not available in the published papers.  This leaves practitioners and policy-makers without the critical information needed to achieve successful implementation of the effective interventions, which may in turn compromise the integrity of the intervention and result in different outcomes.  

As in previous reviews, there continues to be considerable variability in the approaches and intervention components tested for childhood obesity prevention, primarily because the interventions attempt to reduce adiposity through various combinations of targeted behaviours and environments. The methods of implementation are less varied, with the interventions delivered by settings staff, teachers, academics, investigators, or via an electronic media such as the Internet, or a combination of these methods. The majority of included studies were of interventions conducted in educational settings and the majority were implemented for less than 12 months. Thus, the evidence of short-term effectiveness may now be established and further new short-term trials testing similar interventions to those evaluated in this review appear to be no longer warranted. Further, long-term follow-up of trial participants could yield very valuable information on sustainability of effects and we encourage researchers to collect such data.  The review has also revealed significant gaps in the available evidence in relation to younger and older children, as the majority of the research included in this review was focused on behavioural and individual level interventions for children aged six to 12 years. Future reviews should now also determine the effectiveness of environmental and population level interventions, such as those which target changes in infrastructure and policies, to develop a clearer picture of the best possible portfolio of interventions with which to address this public health issue at a population level.  

Authors' conclusions

Implications for practice

The body of evidence in this review provides some support for the hypothesis that obesity prevention interventions in children can be effective, and where examined, have not caused adverse outcomes or increased health inequalities. To this end, the direction of research and evaluation must move into how to implement effectively to scale, sustain the impacts over time and ensure equitable outcomes.  In addition, interventions need to be developed that can be embedded into ongoing practice and operating systems, rather than implementing interventions that are resource intensive and cannot be maintained long-term.

This review also highlights that although we may now have a good sense of the range of interventions feasible for use in reducing the risk of childhood obesity, we lack the knowledge of which specific intervention components are most effective and what is affordable and cost-effective.  Being able to answer these question is of critical importance to decision makers, and economic evaluations must feature in future obesity prevention research if we are to enable well informed decisions about which interventions warrant population-wide implementation. 

Also of particular interest is the safety of obesity prevention efforts in children.  Although measured in only a minority of studies and using a variety of indicators, the studies which measured adverse outcomes or harms reported no adverse intervention effects, even with the intensely individual focus of most of the interventions.  However, significant impacts on adiposity reported from short-term interventions do raise concerns and we recommend that all studies monitor the potential occurrence of unhealthy practices. 

In relation to equity and the incorporation of PROGRESS (Place, Race, Occupation, Gender, Religion, Education, Socio-economic status, Social status), only a minority of studies reported outcomes by any such indicators, and of those that did, the majority focused on SES, followed by race.  The review however provides evidence of significant positive outcomes for the more disadvantaged, and thus those of higher morbidity. There was no evidence for a widening of health inequalities as a result of obesity prevention interventions. In addition, the relatively large numbers of studies either of interventions targeting disadvantaged population groups, or conducted in low- to middle- income countries, also provide useful information about the implementation strategies needed for obesity prevention efforts targeting these high risk groups.  We advocate for assessment of outcomes by measures of equity, such as those indicated by PROGRESS, if a general population is targeted. 

In relation to which interventions should now be implemented more widely, the findings of this review cannot distinguish which specific components of intervention programmes are necessary to achieve beneficial impacts on obesity in children.  As a guide to policy makers planning programmes, the following activities have been included in beneficial programmes:

  • Curriculum on healthy eating, physical activity and body image integrated into regular curriculum

  • More sessions for physical activity and the development of fundamental movement skills throughout the school week

  • Improved nutritional quality of foods made available to students

  • Creating an environment and culture that support children eating nutritious foods and being active throughout each day

  • Providing support for teachers and other staff to implement health promotion strategies and activities (e.g. professional development, capacity building activities)

  • Engaging with parents to support activities in the home setting to encourage children to be more active, eat more nutritious foods and spend less time in screen-based activities

Implications for research

This review demonstrates wide variation in the effectiveness of individual level and behavioural interventions for childhood obesity prevention conducted under trial conditions. On balance, it appears that a variety of interventions can impact on either behaviours or adiposity and shift child outcomes in the desired direction. Given the large number of studies already published, and those currently in the process of being conducted or reported, it seems unnecessary to continue to test short-term interventions that are predominantly individually focused, behavioural interventions in children aged six to 12 years and implemented in schools. To further enhance the evidence base for this age group, we now need to determine which of the approaches and intervention components comprise the optimal package for scaling up for population level implementation. In addition, the research gaps evident from this review relate to effective interventions for children aged 0-5 years (particularly 0-3 years), and for adolescents. Further, more studies testing interventions guided by theories such as the socio-ecological model are warranted. This needs to be coupled with better reporting of the impacts on the environment and setting, and the sustainability of the impacts measured.

In relation to reporting adiposity outcomes, BMI (or zBMI) and prevalence of overweight should both be measured and reported.  To enable systematic reviewers to undertake meta-analyses, reporting the mean and standard deviation for each outcome, as well as the number of participants assessed at each time point in each group are needed.  Process data should also be measured and reported, including data on appropriateness, implementation, feasibility, acceptability, sustainability and context.  Economic data are urgently needed and costs relating to conducting the intervention should be measured and reported, with formal economic evaluations undertaken where possible. In relation to nutrition- and activity-related behaviours, using valid and reliable measures is always the best practice.

Trial designs continue to be compromised by non-random allocation, and investigators should randomise wherever possible.  However, randomisation and allocation concealment may not always be possible, and blinded analysis of outcomes should be used as a means of minimising bias.  In future, we recommend larger, longer term studies powered to detect the small changes that are likely to be found, with assessments of potential harm, equity impacts, implementation factors and sustainability, to enable translation of research findings into effective public health approaches for preventing childhood obesity. 

Key points

  • Obesity prevention interventions show beneficial effects on BMI in a meta-analysis but substantial unexplained heterogeneity of effects and the likelihood of publication bias exist.

  • Testing short-term, behaviourally focused school-based interventions for 6-12 year old children may no longer be warranted

  • More evidence is needed to determine effective interventions in young children, particularly those aged 0-3 years, and adolescents

  • There is a continued need to strengthen trial design, measurement approaches of physical activity and diet-related behaviours, and reporting of process, impact and outcomes

  • Future trials should be larger, longer term and include assessments of costs, harm, equity impacts, implementation factors and sustainability

  • Translational research is required to embed effective interventions into standard practice across children's settings

 

Acknowledgements

The authors would like to thank the Review Advisory Group: Liz Bickerdike (Cochrane Heart Group, Bristol, UK), Margaret Burke (Cochrane Heart Group, Bristol, UK), Tim Lobstein (International Obesity Taskforce, UK), Kellie-Ann Jolley (Director of Active Communities and Healthy Eating Unit, VicHealth), The Parent's Jury, Melbourne, Australia. The authors would particularly like to thank Tahna Pettman, Rachel Clark, Shayne Zang, Priscilla Lai Han Lunn, Jodie Doyle, Rebecca Conning and Alana Pirrone for their contributions and assistance with searching, data extraction and knowledge translation recommendations. The authors would also like to thank Nicole Martin (Cochrane Heart Review Group Trials Search Coordinator), Fleur van de Wetering (Dutch Cochrane Centre) and Rob Scholten (Dutch Cochrane Centre) for their help with translation of papers in German and Dutch for inclusion in this review.

Data and analyses

Download statistical data

Comparison 1. Childhood obesity interventions versus control by age groups 0-5, 6-12 and 13-18 years
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Standardised mean change in Body Mass Index (BMI/zBMI) from baseline to postintervention3727946Std. Mean Difference (IV, Random, 95% CI)-0.15 [-0.21, -0.09]
1.1 0-5 years71815Std. Mean Difference (IV, Random, 95% CI)-0.26 [-0.53, 0.00]
1.2 6-12 years2418983Std. Mean Difference (IV, Random, 95% CI)-0.15 [-0.23, -0.08]
1.3 13-18 years67148Std. Mean Difference (IV, Random, 95% CI)-0.09 [-0.20, 0.03]
Analysis 1.1.

Comparison 1 Childhood obesity interventions versus control by age groups 0-5, 6-12 and 13-18 years, Outcome 1 Standardised mean change in Body Mass Index (BMI/zBMI) from baseline to postintervention.

Appendices

Appendix 1. Search strategies 2010

CENTRAL Issue 1, 2010

Searched 26th March 2010
Limits: CENTRAL Issue 1, 2005 – Issue 1, 2010

1. MeSH descriptor Obesity explode all trees
2. MeSH descriptor Body Weight Changes explode all trees
3. (obes*)
4. ("weight gain" or "weight loss")
5. (overweight or "over weight" or overeat* or (over next eat*))
6. (weight next change*)
7. ((bmi or "body mass index") near (gain or loss or change*))
8. (1 OR 2 OR 3 OR 4 OR 5 OR 6 OR 7)
9. MeSH descriptor Behavior Therapy explode all trees
10. MeSH descriptor Social Support explode all trees
11. MeSH descriptor Psychotherapy, Group explode all trees
12. ((psychological or behavio?r*) near (therapy or modif* or strateg* or intervention*))
13. ("group therapy" or "family therapy" or "cognitive therapy")
14. (lifestyle or "life style") near (chang* or intervention*)
15. counsel?ing
16. "social support"
17. (peer near2 support)
18. (children near3 parent* near3 therapy)
19. (9 OR 10 OR 11 OR 12 OR 13 OR 14 OR 15 OR 16 OR 17 OR 18)
20. MeSH descriptor Obesity explode all trees with qualifier: DH
21. MeSH descriptor Diet Therapy explode all trees
22. MeSH descriptor Fasting, this term only
23. (diets or diet or dieting)
24. diet* near (modif* or therapy or intervention* or strateg*)
25. "low calorie" or (calorie next control*) or "healthy eating"
26. (fasting or (modified next fast*))
27. MeSH descriptor Dietary Fats explode all trees
28. (fruit or vegetable*)
29. (high next fat*) or (low next fat*) or (fatty next food*)
30. formula next diet*
31. (20 OR 21 OR 22 OR 23 OR 24 OR 25 OR 26 OR 27 OR 28 OR 29 OR 30)
32. MeSH descriptor Exercise explode all trees
33. MeSH descriptor Exercise Therapy explode all trees
34. exercis*
35. (aerobics or "physical therapy" or "physical activity" or "physical inactivity")
36. fitness near (class* or regime* or program*)
37. ("physical training" or "physical education")
38. "dance therapy"
39. sedentary next behavio?r*
40. (32 OR 33 OR 34 OR 35 OR 36 OR 37 OR 38 OR 39)
41. MeSH descriptor Complementary Therapies explode all trees
42. "alternative medicine" or (complementary next therap*) or "complementary medicine"
43. (hypnotism or hypnosis or hypnotherapy)
44. (acupuncture or homeopathy or homoeopathy)
45. ("chinese medicine" or "indian medicine" or "herbal medicine" or ayurvedic)
46. (41 OR 42 OR 43 OR 44 OR 45)
47. (diet* or slim*) near (club* or organi?ation)
48. (weightwatcher* or (weight next watcher*))
49. correspondence near (course* or program*)
50. (fat or diet*) next camp*
51. (47 OR 48 OR 49 OR 50)
52. MeSH descriptor Health Promotion explode all trees
53. MeSH descriptor Health Education explode all trees
54. ("health promotion" or "health education")
55. ("media intervention*" or "community intervention*")
56. (health next promoting next school*)
57. ((school or community) near2 program*)
58. ((school or community) near2 intervention*)
59. (family next intervention*) or (parent* next intervention*)
60. (parent* near2 (behavio?r* or involve* or control* or attitude* or educat*))
61. (52 OR 53 OR 54 OR 55 OR 56 OR 57 OR 58 OR 59 OR 60)
62. MeSH descriptor Health Policy explode all trees
63. (health next polic*) or (school next polic*) or (food next polic*) or (nutrition next polic*)
64. (62 OR 63)
65. MeSH descriptor Obesity explode all trees with qualifier: PC
66. MeSH descriptor Primary Prevention explode all trees
67. ("primary prevention" or "secondary prevention")
68. (preventive next measure*) or (preventative next measure*)
69. ("preventive care" or "preventative care")
70. (obesity near2 (prevent* or treat*))
71. (65 OR 66 OR 67 OR 68 OR 69 OR 70)
72. (19 OR 31 OR 40 OR 46 OR 51 OR 61 OR 64 OR 71)
73. (8 AND 72)
74. MeSH descriptor Child explode all trees
75. MeSH descriptor Infant explode all trees
76. (child* or adolescen* or infant*)
77. (teenage* or "young people" or "young person" or (young next adult*))
78. (schoolchildren or "school children")
79. (pediatr* or paediatr*)
80. (boys or girls or youth or youths)
81. MeSH descriptor Adolescent, this term only
82. (74 OR 75 OR 76 OR 77 OR 78 OR 79 OR 80 OR 81)
83. (73 AND 82)

Ovid MEDLINE (1950 to March Week 2 2010)

Searched 24th March 2010
Limits: entry date Feb 2005-search date

1. exp Obesity/
2. Weight Gain/
3. exp Weight Loss/
4. obes$.af.
5. (weight gain or weight loss).af.
6. (overweight or over weight or overeat$ or over eat$).af.
7. weight change$.af.
8. ((bmi or body mass index) adj2 (gain or loss or change)).af.
9. or/1-8
10. exp Behavior Therapy/
11. social support/
12. exp Psychotherapy, Group/
13. ((psychological or behavio?r$) adj (therapy or modif$ or strateg$ or intervention$)).af.
14. (group therapy or family therapy or cognitive therapy).af.
15. ((lifestyle or life style) adj (chang$ or intervention$)).af.
16. counsel?ing.af.
17. social support.af.
18. (peer adj2 support).af.
19. (children adj3 parent$ adj3 therapy).af.
20. or/10-19
21. exp OBESITY/dh [Diet Therapy]
22. exp Diet Therapy/
23. Fasting/
24. (diets or diet or dieting).af.
25. (diet$ adj (modif$ or therapy or intervention$ or strateg$)).af.
26. (low calorie or calorie control$ or healthy eating).af.
27. (fasting or modified fast$).af.
28. exp Dietary Fats/
29. (fruit or vegetable$).af.
30. (high fat$ or low fat$ or fatty food$).af.
31. formula diet$.af.
32. or/21-31
33. exp Exercise/
34. exp Exercise Therapy/
35. exercis$.af.
36. (aerobics or physical therapy or physical activity or physical inactivity).af.
37. (fitness adj (class$ or regime$ or program$)).af.
38. (aerobics or physical therapy or physical training or physical education).af.
39. dance therapy.af.
40. sedentary behavio?r.af.
41. or/33-40
42. exp Complementary Therapies/
43. (alternative medicine or complementary therap$ or complementary medicine).af.
44. (hypnotism or hypnosis or hypnotherapy).af.
45. (acupuncture or homeopathy or homoeopathy).af.
46. (chinese medicine or indian medicine or herbal medicine or ayurvedic).af.
47. or/42-46
48. ((diet or dieting or slim$) adj (club$ or organi?ation)).af.
49. (weightwatcher$ or weight watcher$).af.
50. (correspondence adj (course$ or program$)).af.
51. (fat camp$ or diet$ camp$).af.
52. or/48-51
53. exp Health Promotion/
54. exp Health Education/
55. (health promotion or health education).af.
56. (media intervention$ or community intervention$).af.
57. health promoting school$.af.
58. ((school or community) adj2 program$).af.
59. ((school or community) adj2 intervention$).af.
60. (family intervention$ or parent$ intervention).af.
61. (parent$ adj2 (behavio?r or involve$ or control$ or attitude$ or educat$)).af.
62. or/53-61
63. exp Health Policy/
64. (health polic$ or school polic$ or food polic$ or nutrition polic$).af.
65. 63 or 64
66. exp OBESITY/pc [Prevention & Control]
67. exp Primary Prevention/
68. (primary prevention or secondary prevention).af.
69. (preventive measure$ or preventative measure$).af.
70. (preventive care or preventative care).af.
71. (obesity adj2 (prevent$ or treat$)).af.
72. or/66-71
73. randomized controlled trial.pt.
74. controlled clinical trial.pt.
75. Random Allocation/
76. Double-Blind Method/
77. single-blind method/
78. Placebos/
79. *Research Design/
80. intervention studies/
81. evaluation studies/
82. Comparative Study/
83. exp Longitudinal Studies/
84. cross-over studies/
85. clinical trial.tw.
86. clinical trial.pt.
87. latin square.tw.
88. (time adj series).tw.
89. (before adj2 after adj3 (stud$ or trial$ or design$)).tw.
90. ((singl$ or doubl$ or trebl$ or tripl$) adj5 (blind$ or mask)).tw.
91. placebo$.tw.
92. random$.tw.
93. (matched communities or matched schools or matched populations).tw.
94. control$.tw.
95. (comparison group$ or control group$).tw.
96. matched pairs.tw.
97. (outcome study or outcome studies).tw.
98. (quasiexperimental or quasi experimental or pseudo experimental).tw.
99. (nonrandomi?ed or non randomi?ed or pseudo randomi?sed or quasi randomi?ed).tw.
100. prospectiv$.tw.
101. volunteer$.tw.
102. or/73-101
103. 20 or 32 or 41 or 47 or 52 or 62 or 65 or 72
104. 9 and 102 and 103
105. Animals/
106. exp Child/
107. Adolescent/
108. exp Infant/
109. (child$ or adolescen$ or infant$).af.
110. (teenage$ or young people or young person or young adult$).af.
111. (schoolchildren or school children).af.
112. (pediatr$ or paediatr$).af.
113. (boys or girls or youth or youths).af.
114. or/106-113
115. 104 not 105
116. 114 and 115
117. limit 116 to Date of Publication from 20050201-

EMBASE OVID (1980 to 2010 Week 11)

Searched 24th March 2010
Limits: entry 2005-2010

1. exp obesity/
2. weight gain/
3. weight reduction/
4. obes$.af.
5. (weight gain or weight loss).af.
6. (overweight or over weight or overeat$ or over eat$).af.
7. weight change$.af.
8. ((bmi or body mass index) adj2 (gain or loss or change)).af.
9. or/1-8
10. behavior therapy/
11. social support/
12. family therapy/
13. group therapy/
14. ((psychological or behavio?r$) adj (therapy or modif$ or strateg$ or intervention$)).af.
15. (group therapy or family therapy or cognitive therapy).af.
16. ((lifestyle or life style) adj (chang$ or intervention$)).af.
17. counsel?ing.af.
18. social support.af.
19. (peer adj2 support).af.
20. (children adj3 parent$ adj3 therapy).af.
21. or/10-20
22. exp diet therapy/
23. (diets or diet or dieting).af.
24. (diet$ adj (modif$ or therapy or intervention$ or strateg$)).af.
25. (low calorie or calorie control$ or healthy eating).af.
26. (fasting or modified fast$).af.
27. exp fat intake/
28. (fruit or vegetable$).af.
29. (high fat$ or low fat$ or fatty food$).af.
30. formula diet$.af.
31. or/22-30
32. exp exercise/
33. exp kinesiotherapy/
34. exercis$.af.
35. (aerobics or physical therapy or physical activity or physical inactivity).af.
36. (fitness adj (class$ or regime$ or program$)).af.
37. (aerobics or physical therapy or physical training or physical education).af.
38. dance therapy.af.
39. sedentary behavio?r.af.
40. or/32-39
41. exp alternative medicine/
42. (alternative medicine or complementary therap$ or complementary medicine).af.
43. (hypnotism or hypnosis or hypnotherapy).af.
44. (acupuncture or homeopathy or homoeopathy).af.
45. (chinese medicine or indian medicine or herbal medicine or ayurvedic).af.
46. or/41-45
47. ((diet or dieting or slim$) adj (club$ or organi?ation)).af.
48. (weightwatcher$ or weight watcher$).af.
49. (correspondence adj (course$ or program$)).af.
50. (fat camp$ or diet$ camp$).af.
51. or/47-50
52. exp health education/
53. (health promotion or health education).af.
54. (media intervention$ or community intervention$).af.
55. health promoting school$.af.
56. ((school or community) adj2 program$).af.
57. ((school or community) adj2 intervention$).af.
58. (family intervention$ or parent$ intervention).af.
59. (parent$ adj2 (behavio?r or involve$ or control$ or attitude$ or educat$)).af.
60. or/52-59
61. health care policy/
62. (health polic$ or school polic$ or food polic$ or nutrition polic$).af.
63. 61 or 62
64. exp obesity/pc [Prevention]
65. primary prevention/
66. (primary prevention or secondary prevention).af.
67. (preventive measure$ or preventative measure$).af.
68. (preventive care or preventative care).af.
69. (obesity adj2 (prevent$ or treat$)).af.
70. or/64-69
71. exp clinical trial/
72. exp Randomized Controlled Trial/
73. randomization/
74. exp Double-Blind procedure/
75. exp Single-Blind procedure/
76. exp Crossover procedure/
77. clinical trial.tw.
78. ((singl$ or doubl$ or treble$ or tripl$) and (mask$ or blind$)).tw.
79. latin square.tw.
80. placebo/
81. placebo$.tw.
82. random$.tw.
83. Comparative Study/
84. evaluation/
85. clinical trial.tw.
86. latin square.tw.
87. (before adj2 after adj3 (stud$ or trial$ or design$)).tw.
88. ((singl$ or doubl$ or trebl$ or tripl$) adj5 (blind$ or mask)).tw.
89. (matched communities or matched schools or matched populations).tw.
90. control$.tw.
91. (comparison group$ or control group$).tw.
92. matched pairs.tw.
93. (outcome study or outcome studies).tw.
94. (quasiexperimental or quasi experimental or pseudo experimental).tw.
95. (nonrandomi?ed or non randomi?ed or pseudo randomi?sed or quasi randomi?ed).tw.
96. prospectiv$.tw.
97. volunteer$.tw.
98. or/71-97
99. 21 or 31 or 40 or 46 or 51 or 60 or 63 or 70
100. 9 and 98 and 99
101. animal/
102. exp child/
103. exp ADOLESCENT/
104. exp preschool child/
105. exp infant/
106. (child$ or adolescen$ or infant$).af.
107. (teenage$ or young people or young person or young adult$).af.
108. (schoolchildren or school children).af.
109. (pediatr$ or paediatr$).af.
110. (boys or girls or youth or youths).af.
111. or/102-110
112. 100 not 101
113. 111 and 112
114. 113 and [2005-2010]/py

PsycINFO 1806 to March Week 3 2010

Searched 24th March 2010
Limits: Date Range: 2005-2010

1. exp overweight/
2. weight control/
3. obes*.tw.
4. weight gain*.tw.
5. weight loss*.tw.
6. (overweight or over weight).tw.
7. weight loss/
8. weight gain/
9. (overeat* or over eat*).tw.
10. weight change*.tw.
11. ((bmi or body mass) adj3 (gain* or loss* or change*)).tw.
12. or/1-11
13. (adolescence 13 17 yrs or childhood birth 12 yrs or infancy 2 23 mo or neonatal birth 1 mo or preschool age 2 5 yrs or school age 6 12 yrs).ag.
14. (child* or adolescen*).tw.
15. (child* or adololescen* or infant*).tw.
16. (pediatr* or paediatr*).tw.
17. (boys or girls or youth or youths).tw.
18. or/13-17
19. 12 and 18
20. exp experimental design/
21. exp clinical trials/
22. (clinical* stud* or single-blind or single blind or triple-blind or triple blind).tw.
23. (random* or clinical trial* or controlled study or double-blind or double blind).tw.
24. (matched communit* or matched school* or matched population*).tw.
25. ((control or comparison) adj group).tw.
26. (outcome study or outcome studies).tw.
27. matched pair*.tw.
28. (quasiexperimental or quasi experimental or pseudo experimental).tw.
29. prospectiv*.tw.
30. volunteer*.tw.
31. ("before and after" adj3 (trial* or study or studies or design*)).tw.
32. time series.tw.
33. latin square.tw.
34. or/20-33
35. 19 and 34
36. limit 35 to Date Range: 2005 to 2010

CINAHL Plus with Full Text

Searched 25th March 2010
Limits: entry date Feb 2005 -

1. (MH "Obesity+")
2. (MH "Weight Gain")
3. (MH "Weight Loss")
4. (TI obese or obesity) OR (AB obese or obesity)
5. (TI weight gain or weight loss) OR (AB weight gain or weight loss)
6. (TI weight change*) OR (AB weight change*)
7. (TI bmi N2 loss) OR (AB bmi N2 loss)
8. (TI bmi N2 gain) OR (AB bmi N2 gain)
9. (TI bmi N2 change) OR (AB bmi N2 change)
10. (TI body mass index N2 change) OR (AB body mass index N2 change)
11. (TI body mass index N2 gain) OR (AB body mass index N2 gain)
12. (TI body mass index N2 loss) OR (AB body mass index N2 loss)
13. (1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12)
14. (MH "Child+")
15. (MH "Child")
16. (MH "Infant+")
17. (MH "Adolescence")
18. (TI child* or adolescen* or infant*) OR (AB child* or adolescen* or infant*)
19. (TI teenage$ or young people or young person or young adult*) OR (AB teenage$ or young people r young person or young adult*)
20. (TI schoolchildren) OR (AB schoolchildren)
21. (14 or 15 or 16 or 17 or 18 or 19 or 20)
22. 13 and 21
23. (MH "Study Design+")
24. (MH "Evaluation Research+")
25. (MH "Comparative Studies")
26. (MH "Random Assignment")
27. (MH "Random Sample+")
28. (MH "Placebos")
29. (MH "Clinical Trials")
30. (PT "CLINICAL TRIAL")
31. clin* N25 trial*
32. clin* N25 stud*
33. latin square
34. time series
35. TX random*
36. TX matched communities or matched schools or matched populations
37. TX comparison group*
38. TX matched pair*
39. TX outcome study or outcome studies
40. TX quasiexperimental or quasi experimental or pseudo experimental
41. TX nonrandomi* or pseudorandomi* or quasirandomi*
42. TX prospectiv*
43. TX volunteer
44. (23 or 24 or 25 or 26 or 27 or 28 or 29 or 30 or 31 or 32 or 33 or 34 or 35 or 36 or 37 or 38 or 39 or 40 or 41 or 42 or 43)
45. 22 and 44
46. 45 and em 200502-

Appendix 2. Search strategies 2005

CENTRAL (on The Cochrane Library) (2005 update)

Issue 1, 2005

1. exp OBESITY/
2. exp Weight Gain/
3. exp Weight Loss/
4. obes$.af.
5. (weight gain or weight loss).af.
6. (overweight or over weight or overeat$ or over eat$).af.
7. weight change$.af.
8. ((bmi or body mass index) adj2 (gain or loss or change)).af.
9. or/1-8
10. exp Behavior Therapy/
11. exp Social Support/
12. exp Family Therapy/
13. exp Psychotherapy, Group/
14. ((psychological or behavio?r$) adj (therapy or modif$ or strateg$ or intervention$)).af.
15. (group therapy or family therapy or cognitive therapy).af.
16. ((lifestyle or life style) adj (chang$ or intervention$)).af.
17. counsel?ing.af.
18. social support.af.
19. (peer adj2 support).af.
20. (children adj3 parent$ adj therapy).af.
21. or/10-20
22. exp OBESITY/dh [Diet Therapy]
23. exp Diet, Fat-Restricted/
24. exp Diet, Reducing/
25. exp Diet Therapy/
26. exp FASTING/
27. (diets or diet or dieting).af.
28. (diet$ adj (modif$ or therapy or intervention$ or strateg$)).af.
29. (low calorie or calorie control$ or healthy eating).af.
30. (fasting or modified fast$).af.
31. exp Dietary Fats/
32. (fruit or vegetable$).af.
33. (high fat$ or low fat$ or fatty food$).af.
34. formula diet$.af.
35. or/22-34
36. exp EXERCISE/
37. exp Exercise Therapy/
38. exercis$.af.
39. (aerobics or physical therapy or physical activity or physical inactivity).af.
40. (fitness adj (class$ or regime$ or program$)).af.
41. (aerobics or physical therapy or physical training or physical education).af.
42. dance therapy.af.
43. sedentary behavio?r.af.
44. or/36-43
45. exp Complementary Therapies/
46. (alternative medicine or complementary therap$ or complementary medicine).af.
47. (hypnotism or hypnosis or hypnotherapy).af.
48. (acupuncture or homeopathy or homoeopathy).af.
49. (chinese medicine or indian medicine or herbal medicine or ayurvedic).af.
50. or/45-49
51. ((diet or dieting or slim$) adj (club$ or organi?ation)).af.
52. (weightwatcher$ or weight watcher$).af.
53. (correspondence adj (course$ or program$)).af.
54. (fat camp$ or diet$ camp$).af.
55. or/51-54
56. exp Health Promotion/
57. exp Health Education/
58. (health promotion or health education).af.
59. (media intervention$ or community intervention$).af.
60. health promoting school$.af.
61. ((school or community) adj2 program$).af.
62. ((school or community) adj2 intervention$).af.
63. (family intervention$ or parent$ intervention).af.
64. (parent$ adj2 (behavio?r or involve$ or control$ or attitude$ or educat$)).af.
65. or/56-64
66. exp Health Policy/
67. exp Nutrition Policy/
68. (health polic$ or school polic$ or food polic$ or nutrition polic$).af.
69. or/66-68
70. exp OBESITY/pc [Prevention & Control]
71. exp Primary Prevention/
72. (primary prevention or secondary prevention).af.
73. (preventive measure$ or preventative measure$).af.
74. (preventive care or preventative care).af.
75. (obesity adj2 (prevent$ or treat$)).af.
76. or/70-75
77. randomized controlled trial.pt.
78. controlled clinical trial.pt.
79. exp Controlled Clinical Trials/
80. exp Random Allocation/
81. exp Double-Blind Method/
82. exp Single-Blind Method/
83. exp Placebos/
84. *Research Design/
85. exp Intervention studies/
86. exp Evaluation studies/
87. exp Comparative Study/
88. exp Follow-Up Studies/
89. exp Prospective Studies/
90. exp Cross-over Studies/
91. clinical trial.tw.
92. clinical trial.pt.
93. latin square.tw.
94. (time adj series).tw.
95. (before adj2 after adj3 (stud$ or trial$ or design$)).tw.
96. ((singl$ or doubl$ or trebl$ or tripl$) adj5 (blind$ or mask)).tw.
97. placebo$.tw.
98. random$.tw.
99. (matched communities or matched schools or matched populations).tw.
100. control$.tw.
101. (comparison group$ or control group$).tw.
102. matched pairs.tw.
103. (outcome study or outcome studies).tw.
104. (quasiexperimental or quasi experimental or pseudo experimental).tw.
105. (nonrandomi?ed or non randomi?ed or pseudo randomi?sed or quasi randomi?ed).tw.
106. prospectiv$.tw.
107. volunteer$.tw.
108. or/77-107
109. 21 or 35 or 44 or 50 or 55 or 65 or 69 or 76
110. 9 and 109 and 108
111. Animals/
112. exp CHILD/
113. exp CHILD, PRESCHOOL/ or CHILD/
114. exp INFANT/
115. (child$ or adolescen$ or infant$).af.
116. (teenage$ or young people or young person or young adult$).af.
117. (schoolchildren or school children).af.
118. (pediatr$ or paediatr$).af.
119. (boys or girls or youth or youths).af.
120. or/112-119
121. 110 not 111
122. 121 and 120

MEDLINE (through Ovid) (2005 update)

Searched 12 February 2005/16 February 2005

1. exp OBESITY/
2. exp Weight Gain/
3. exp Weight Loss/
4. obes$.af.
5. (weight gain or weight loss).af.
6. (overweight or over weight or overeat$ or over eat$).af.
7. weight change$.af.
8. ((bmi or body mass index) adj2 (gain or loss or change)).af.
9. or/1-8
10. exp Behavior Therapy/
11. exp Social Support/
12. exp Family Therapy/
13. exp Psychotherapy, Group/
14. ((psychological or behavio?r$) adj (therapy or modif$ or strateg$ or intervention$)).af.
15. (group therapy or family therapy or cognitive therapy).af.
16. ((lifestyle or life style) adj (chang$ or intervention$)).af.
17. counsel?ing.af.
18. social support.af.
19. (peer adj2 support).af.
20. (children adj3 parent$ adj therapy).af.
21. or/10-20
22. exp OBESITY/dh [Diet Therapy]
23. exp Diet, Fat-Restricted/
24. exp Diet, Reducing/
25. exp Diet Therapy/
26. exp FASTING/
27. (diets or diet or dieting).af.
28. (diet$ adj (modif$ or therapy or intervention$ or strateg$)).af.
29. (low calorie or calorie control$ or healthy eating).af.
30. (fasting or modified fast$).af.
31. exp Dietary Fats/
32. (fruit or vegetable$).af.
33. (high fat$ or low fat$ or fatty food$).af.
34. formula diet$.af.
35. or/22-34
36. exp EXERCISE/
37. exp Exercise Therapy/
38. exercis$.af.
39. (aerobics or physical therapy or physical activity or physical inactivity).af.
40. (fitness adj (class$ or regime$ or program$)).af.
41. (aerobics or physical therapy or physical training or physical education).af.
42. dance therapy.af.
43. sedentary behavio?r.af.
44. or/36-43
45. exp Complementary Therapies/
46. (alternative medicine or complementary therap$ or complementary medicine).af.
47. (hypnotism or hypnosis or hypnotherapy).af.
48. (acupuncture or homeopathy or homoeopathy).af.
49. (chinese medicine or indian medicine or herbal medicine or ayurvedic).af.
50. or/45-49
51. ((diet or dieting or slim$) adj (club$ or organi?ation)).af.
52. (weightwatcher$ or weight watcher$).af.
53. (correspondence adj (course$ or program$)).af.
54. (fat camp$ or diet$ camp$).af.
55. or/51-54
56. exp Health Promotion/
57. exp Health Education/
58. (health promotion or health education).af.
59. (media intervention$ or community intervention$).af.
60. health promoting school$.af.
61. ((school or community) adj2 program$).af.
62. ((school or community) adj2 intervention$).af.
63. (family intervention$ or parent$ intervention).af.
64. (parent$ adj2 (behavio?r or involve$ or control$ or attitude$ or educat$)).af.
65. or/56-64
66. exp Health Policy/
67. exp Nutrition Policy/
68. (health polic$ or school polic$ or food polic$ or nutrition polic$).af.
69. or/66-68
70. exp OBESITY/pc [Prevention & Control]
71. exp Primary Prevention/
72. (primary prevention or secondary prevention).af.
73. (preventive measure$ or preventative measure$).af.
74. (preventive care or preventative care).af.
75. (obesity adj2 (prevent$ or treat$)).af.
76. or/70-75
77. randomized controlled trial.pt.
78. controlled clinical trial.pt.
79. exp Controlled Clinical Trials/
80. exp Random Allocation/
81. exp Double-Blind Method/
82. exp Single-Blind Method/
83. exp Placebos/
84. *Research Design/
85. exp Intervention studies/
86. exp Evaluation studies/
87. exp Comparative Study/
88. exp Follow-Up Studies/
89. exp Prospective Studies/
90. exp Cross-over Studies/
91. clinical trial.tw.
92. clinical trial.pt.
93. latin square.tw.
94. (time adj series).tw.
95. (before adj2 after adj3 (stud$ or trial$ or design$)).tw.
96. ((singl$ or doubl$ or trebl$ or tripl$) adj5 (blind$ or mask)).tw.
97. placebo$.tw.
98. random$.tw.
99. (matched communities or matched schools or matched populations).tw.
100. control$.tw.
101. (comparison group$ or control group$).tw.
102. matched pairs.tw.
103. (outcome study or outcome studies).tw.
104. (quasiexperimental or quasi experimental or pseudo experimental).tw.
105. (nonrandomi?ed or non randomi?ed or pseudo randomi?sed or quasi randomi?ed).tw.
106. prospectiv$.tw.
107. volunteer$.tw.
108. or/77-107
109. 21 or 35 or 44 or 50 or 55 or 65 or 69 or 76
110. 9 and 109 and 108
111. Animals/
112. exp CHILD/
113. exp ADOLESCENT/
114. exp CHILD, PRESCHOOL/ or CHILD/
115. exp INFANT/
116. (child$ or adolescen$ or infant$).af.
117. (teenage$ or young people or young person or young adult$).af.
118. (schoolchildren or school children).af.
119. (pediatr$ or paediatr$).af.
120. (boys or girls or youth or youths).af.
121. or/112-120
122. 110 not 111
123. 122 and 121
124. limit 123 to yr=1990-2005

EMBASE (2005 update)

Dates 1990 to 2005

1. exp OBESITY/
2. exp Weight Gain/
3. exp Weight Loss/
4. obes$.af.
5. (weight gain or weight loss).af.
6. (overweight or over weight or overeat$ or over eat$).af.
7. weight change$.af.
8. ((bmi or body mass index) adj2 (gain or loss or change)).af.
9. or/1-8
10. exp Behavior Therapy/
11. exp Social Support/
12. exp Family Therapy/
13. exp Psychotherapy, Group/
14. ((psychological or behavio?r$) adj (therapy or modif$ or strateg$ or intervention$)).af.
15. (group therapy or family therapy or cognitive therapy).af.
16. ((lifestyle or life style) adj (chang$ or intervention$)).af.
17. counsel?ing.af.
18. social support.af.
19. (peer adj2 support).af.
20. (children adj3 parent$ adj therapy).af.
21. or/10-20
22. exp OBESITY/dh [Diet Therapy]
23. exp Diet, Fat-Restricted/
24. exp Diet, Reducing/
25. exp Diet Therapy/
26. exp FASTING/
27. (diets or diet or dieting).af.
28. (diet$ adj (modif$ or therapy or intervention$ or strateg$)).af.
29. (low calorie or calorie control$ or healthy eating).af.
30. (fasting or modified fast$).af.
31. exp Dietary Fats/
32. (fruit or vegetable$).af.
33. (high fat$ or low fat$ or fatty food$).af.
34. formula diet$.af.
35. or/22-34
36. exp EXERCISE/
37. exp Exercise Therapy/
38. exercis$.af.
39. (aerobics or physical therapy or physical activity or physical inactivity).af.
40. (fitness adj (class$ or regime$ or program$)).af.
41. (aerobics or physical therapy or physical training or physical education).af.
42. dance therapy.af.
43. sedentary behavio?r.af.
44. or/36-43
45. exp Complementary Therapies/
46. (alternative medicine or complementary therap$ or complementary medicine).af.
47. (hypnotism or hypnosis or hypnotherapy).af.
48. (acupuncture or homeopathy or homoeopathy).af.
49. (chinese medicine or indian medicine or herbal medicine or ayurvedic).af.
50. or/45-49
51. ((diet or dieting or slim$) adj (club$ or organi?ation)).af.
52. (weightwatcher$ or weight watcher$).af.
53. (correspondence adj (course$ or program$)).af.
54. (fat camp$ or diet$ camp$).af.
55. or/51-54
56. exp Health Promotion/
57. exp Health Education/
58. (health promotion or health education).af.
59. (media intervention$ or community intervention$).af.
60. health promoting school$.af.
61. ((school or community) adj2 program$).af.
62. ((school or community) adj2 intervention$).af.
63. (family intervention$ or parent$ intervention).af.
64. (parent$ adj2 (behavio?r or involve$ or control$ or attitude$ or educat$)).af.
65. or/56-64
66. exp Health Policy/
67. exp Nutrition Policy/
68. (health polic$ or school polic$ or food polic$ or nutrition polic$).af.
69. or/66-68
70. exp OBESITY/pc [Prevention & Control]
71. exp Primary Prevention/
72. (primary prevention or secondary prevention).af.
73. (preventive measure$ or preventative measure$).af.
74. (preventive care or preventative care).af.
75. (obesity adj2 (prevent$ or treat$)).af.
76. or/70-75
77. exp Clinical Trial/
78. exp Randomized Controlled Trial/
79. exp Randomization/
80. exp Double-Blind procedure/
81. exp Single-Blind procedure/
82. exp Crossover procedure/
83. clinical trial.tw.
84. ((singl$ or doubl$ or treble$ or tripl$) and (mask$ or blind$)).tw.
85. latin square.tw.
86. exp PLACEBO/
87. placebo$.tw.
88. random$.tw.
89. Comparative Study/
90. exp Evaluation/
91. clinical trial.tw.
92. clinical trial.pt.
93. latin square.tw.
94. (before adj2 after adj3 (stud$ or trial$ or design$)).tw.
95. ((singl$ or doubl$ or trebl$ or tripl$) adj5 (blind$ or mask)).tw.
96. placebo$.tw.
97. random$.tw.
98. (matched communities or matched schools or matched populations).tw.
99. control$.tw.
100. (comparison group$ or control group$).tw.
101. matched pairs.tw.
102. (outcome study or outcome studies).tw.
103. (quasiexperimental or quasi experimental or pseudo experimental).tw.
104. (nonrandomi?ed or non randomi?ed or pseudo randomi?sed or quasi randomi?ed).tw.
105. prospectiv$.tw.
106. volunteer$.tw.
107. or/77-107
108. 21 or 35 or 44 or 50 or 55 or 65 or 69 or 76
109. 9 and 108 and 107
110. Animals/
111. exp CHILD/
112. exp ADOLESCENT/
113. exp CHILD, PRESCHOOL/ or CHILD/
114. exp INFANT/
115. (child$ or adolescen$ or infant$).af.
116. (teenage$ or young people or young person or young adult$).af.
117. (schoolchildren or school children).af.
118. (pediatr$ or paediatr$).af.
119. (boys or girls or youth or youths).af.
120. or/111-119
121. 109 not 110
122. 121 and 120
123. limit 122 to yr=1990-2005 

PsycINFO (2005 update)

Date 1990 to 2005

1. exp OBESITY/
2. exp Weight Gain/
3. exp Weight Loss/
4. obes$.af.
5. (weight gain or weight loss).af.
6. (overweight or over weight or overeat$ or over eat$).af.
7. weight change$.af.
8. ((bmi or body mass index) adj2 (gain or loss or change)).af.
9. or/1-8
10. exp Behavior Therapy/
11. exp Social Support/
12. exp Family Therapy/
13. exp Psychotherapy, Group/
14. ((psychological or behavio?r$) adj (therapy or modif$ or strateg$ or intervention$)).af.
15. (group therapy or family therapy or cognitive therapy).af.
16. ((lifestyle or life style) adj (chang$ or intervention$)).af.
17. counsel?ing.af.
18. social support.af.
19. (peer adj2 support).af.
20. (children adj3 parent$ adj therapy).af.
21. or/10-20
22. exp OBESITY/dh [Diet Therapy]
23. exp Diet, Fat-Restricted/
24. exp Diet, Reducing/
25. exp Diet Therapy/
26. exp FASTING/
27. (diets or diet or dieting).af.
28. (diet$ adj (modif$ or therapy or intervention$ or strateg$)).af.
29. (low calorie or calorie control$ or healthy eating).af.
30. (fasting or modified fast$).af.
31. exp Dietary Fats/
32. (fruit or vegetable$).af.
33. (high fat$ or low fat$ or fatty food$).af.
34. formula diet$.af.
35. or/22-34
36. exp EXERCISE/
37. exp Exercise Therapy/
38. exercis$.af.
39. (aerobics or physical therapy or physical activity or physical inactivity).af.
40. (fitness adj (class$ or regime$ or program$)).af.
41. (aerobics or physical therapy or physical training or physical education).af.
42. dance therapy.af.
43. sedentary behavio?r.af.
44. or/36-43
45. exp Complementary Therapies/
46. (alternative medicine or complementary therap$ or complementary medicine).af.
47. (hypnotism or hypnosis or hypnotherapy).af.
48. (acupuncture or homeopathy or homoeopathy).af.
49. (chinese medicine or indian medicine or herbal medicine or ayurvedic).af.
50. or/45-49
51. ((diet or dieting or slim$) adj (club$ or organi?ation)).af.
52. (weightwatcher$ or weight watcher$).af.
53. (correspondence adj (course$ or program$)).af.
54. (fat camp$ or diet$ camp$).af.
55. or/51-54
56. exp Health Promotion/
57. exp Health Education/
58. (health promotion or health education).af.
59. (media intervention$ or community intervention$).af.
60. health promoting school$.af.
61. ((school or community) adj2 program$).af.
62. ((school or community) adj2 intervention$).af.
63. (family intervention$ or parent$ intervention).af.
64. (parent$ adj2 (behavio?r or involve$ or control$ or attitude$ or educat$)).af.
65. or/56-64
66. exp Health Policy/
67. exp Nutrition Policy/
68. (health polic$ or school polic$ or food polic$ or nutrition polic$).af.
69. or/66-68
70. exp OBESITY/pc [Prevention & Control]
71. exp Primary Prevention/
72. (primary prevention or secondary prevention).af.
73. (preventive measure$ or preventative measure$).af.
74. (preventive care or preventative care).af.
75. (obesity adj2 (prevent$ or treat$)).af.
76. or/70-75
77. 21 or 35 or 44 or 50 or 55 or 65 or 69 or 76
78. Animals/
79. (child$ or adolescen$ or infant$).af.
80. (teenage$ or young people or young person or young adult$).af.
81. (schoolchildren or school children).af.
82. (pediatr$ or paediatr$).af.
83. (boys or girls or youth or youths).af.
84. or/79-82
85. 9 and 77 and 84
86. 85 not 78 

CINAHL (2005 update)

Date 1990 to 2005

1. exp OBESITY/
2. exp Weight Gain/
3. exp Weight Loss/
4. obes$.af.
5. (weight gain or weight loss).af.
6. (overweight or over weight or overeat$ or over eat$).af.
7. weight change$.af.
8. ((bmi or body mass index) adj2 (gain or loss or change)).af.
9. or/1-8
10. exp Behavior Therapy/
11. exp Social Support/
12. exp Family Therapy/
13. exp Psychotherapy, Group/
14. ((psychological or behavio?r$) adj (therapy or modif$ or strateg$ or intervention$)).af.
15. (group therapy or family therapy or cognitive therapy).af.
16. ((lifestyle or life style) adj (chang$ or intervention$)).af.
17. counsel?ing.af.
18. social support.af.
19. (peer adj2 support).af.
20. (children adj3 parent$ adj therapy).af.
21. or/10-20
22. exp OBESITY/dh [Diet Therapy]
23. exp Diet, Fat-Restricted/
24. exp Diet, Reducing/
25. exp Diet Therapy/
26. exp FASTING/
27. (diets or diet or dieting).af.
28. (diet$ adj (modif$ or therapy or intervention$ or strateg$)).af.
29. (low calorie or calorie control$ or healthy eating).af.
30. (fasting or modified fast$).af.
31. exp Dietary Fats/
32. (fruit or vegetable$).af.
33. (high fat$ or low fat$ or fatty food$).af.
34. formula diet$.af.
35. or/22-34
36. exp EXERCISE/
37. exp Exercise Therapy/
38. exercis$.af.
39. (aerobics or physical therapy or physical activity or physical inactivity).af.
40. (fitness adj (class$ or regime$ or program$)).af.
41. (aerobics or physical therapy or physical training or physical education).af.
42. dance therapy.af.
43. sedentary behavio?r.af.
44. or/36-43
45. exp Complementary Therapies/
46. (alternative medicine or complementary therap$ or complementary medicine).af.
47. (hypnotism or hypnosis or hypnotherapy).af.
48. (acupuncture or homeopathy or homoeopathy).af.
49. (chinese medicine or indian medicine or herbal medicine or ayurvedic).af.
50. or/45-49
51. ((diet or dieting or slim$) adj (club$ or organi?ation)).af.
52. (weightwatcher$ or weight watcher$).af.
53. (correspondence adj (course$ or program$)).af.
54. (fat camp$ or diet$ camp$).af.
55. or/51-54
56. exp Health Promotion/
57. exp Health Education/
58. (health promotion or health education).af.
59. (media intervention$ or community intervention$).af.
60. health promoting school$.af.
61. ((school or community) adj2 program$).af.
62. ((school or community) adj2 intervention$).af.
63. (family intervention$ or parent$ intervention).af.
64. (parent$ adj2 (behavio?r or involve$ or control$ or attitude$ or educat$)).af.
65. or/56-64
66. exp Health Policy/
67. exp Nutrition Policy/
68. (health polic$ or school polic$ or food polic$ or nutrition polic$).af.
69. or/66-68
70. exp OBESITY/pc [Prevention & Control]
71. exp Primary Prevention/
72. (primary prevention or secondary prevention).af.
73. (preventive measure$ or preventative measure$).af.
74. (preventive care or preventative care).af.
75. (obesity adj2 (prevent$ or treat$)).af.
76. or/70-75
77. exp study design/
78. exp evaluation research/
79. exp comparative studies/
80. exp Random Assignment/
81. exp Random sample/
82. exp Placebos/
83. exp Prospective Studies/
84. clinical trial.tw.
85. clinical trial.pt.
86. (clin$ adj25 (trial$ or stud$)).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
87. latin square.tw.
88. (time adj series).tw.
89. (before adj2 after adj3 (stud$ or trial$ or design$)).tw.
90. ((singl$ or doubl$ or trebl$ or tripl$) adj5 (blind$ or mask)).tw.
91. placebo$.tw.
92. random$.tw.
93. (matched communities or matched schools or matched populations).tw.
94. control$.tw.
95. (comparison group$ or control group$).tw.
96. matched pairs.tw.
97. (outcome study or outcome studies).tw.
98. (quasiexperimental or quasi experimental or pseudo experimental).tw.
99. (nonrandomi?ed or non randomi?ed or pseudo randomi?sed or quasi randomi?ed).tw.
100. prospectiv$.tw.
101. volunteer$.tw.
102. or/77-101
103. 21 or 35 or 44 or 50 or 55 or 65 or 69 or 76
104. Animals/
105. exp CHILD/
106. exp ADOLESCENT/
107. exp CHILD, PRESCHOOL/ or CHILD/
108. exp INFANT/
109. (child$ or adolescen$ or infant$).af.
110. (teenage$ or young people or young person or young adult$).af.
111. (schoolchildren or school children).af.
112. (pediatr$ or paediatr$).af.
113. (boys or girls or youth or youths).af.
114. or/105-113
115. 9 and 103
116. 115 and 102 and 114
117. 116 not 104

What's new

DateEventDescription
1 August 2013AmendedRepublished under new editorial group (from Heart to Public Health Group), with no changes to the text of the review.

History

Protocol first published: Issue 4, 1999
Review first published: Issue 1, 2001

DateEventDescription
27 May 2011New citation required but conclusions have not changedIn this update, we reran the search for studies up to March 2010 and 36 additional new studies have now been included (the previous version of this review included 22 studies, however three of the original 22 studies have now been moved to excluded studies). A meta-analysis has been conducted and demonstrates marked heterogeneity, but with estimates of effects that are unlikely to be due to chance. Data extraction has been expanded in this review update to include a variety of "implementation factors" to aid contextualisation and utilisation of findings.  
3 July 2008AmendedConverted to new review format.
1 July 2005New search has been performedSearch strategies run in February 2005. The inclusion criteria were changed to exclude studies published before 1990.
Twelve new studies were included. Three long-term studies of 1 year or more (Caballero 2003; James 2004; Warren 2003) and nine short-term studies of 3 months to 1 year (Baranowski 2003; Beech 2003; Dennison 2004; Harvey-Berino 2003; Kain 2004; Neumark-Sztainer 2003; Pangrazi 2004; Robinson 2003; Story 2003).
One study (Simonetti 1986) was excluded because it was published before 1990. This study had been included in earlier version of this review.
The conclusions were amended slightly, but the main direction and intent of the conclusions did not change. The background section was updated. The methodology used for this update was changed to include additional search terms and information from study evaluations in keeping with the broader approach of health promotion and public health reviews.
1 April 2002New search has been performedSearch strategies were rerun and review content updated accordingly.

Contributions of authors

Elizabeth Waters lead the review process, provided the overall structure and process, provided advice with data extraction, meta-analysis and data synthesis decisions, helped to write the review text and contributed to previous versions of this review.
Andrea de Silva-Sanigorski lead the review process, extracted data, performed the meta-analysis, performed data synthesis, and wrote the review text.
Belinda Hall extracted data, helped with the meta-analysis, performed data synthesis and wrote the review text.
Tamara Brown helped with data extraction, commented on the final review and contributed to previous versions of this review.
Karen Campbell helped with data extraction, commented on the final review and contributed to previous versions of this review.
Gemma Gao helped with data extraction and commented on the final review.
Rebecca Armstrong worked on the amended protocol, provided searching advice, helped to develop the extraction template and commented on the final review.
Lauren Prosser helped with searching, data extraction and commented on the final review.
Carolyn Summerbell commented on the final review and contributed to previous versions of this review

Declarations of interest

There are no conflicts of interest to report.

Sources of support

Internal sources

  • School of Health and Social Care, University of Teesside, UK.

  • School of Population Health, University of Melbourne, Australia.

  • Centre for Physical Activity and Nutrition Research, Deakin University, Australia.

  • Jack Brockhoff Child Health and Wellbeing Program, Australia.

External sources

  • Department of Health, UK.

  • World Health Organisation, Switzerland.

  • Victorian Health Promotion Foundation (VicHealth), Victoria, Australia.

  • Commonwealth Department of Health and Ageing, Australia.

  • National Health and Medical Research Council Capacity Building Grant, Australia.

  • The Jack Brockhoff Foundation, Australia.

  • Karen Campbell is supported by a VicHealth Fellowship, Australia.

  • Andrea de Silva Sanigorski is funded by an NHMRC Capacity Building Program for Child and Adolescent Obesity Prevention, Australia.

Differences between protocol and review

Previous versions of this review recorded the following differences between the protocol and the review : Duration referred to the intervention itself or to a combination of the intervention with a follow-up phase. However, in light of the very small numbers of studies (n = 3) that met this criterion for the first version of this review (published in 2001) we changed the criteria to include shorter term studies with minimum duration three months. We reviewed our protocol in light of the Cochrane Guidelines for Health Promotion and Public Health Reviews (Armstrong 2007) and changed the inclusion criteria of this study to exclude studies published before 1990.

For this update, the minimum duration of 12 weeks was maintained. In previous versions of the review the 12-week duration referred to the length of the intervention itself or to a combination of the intervention with a follow-up phase. For this review update, studies were required to have minimum intervention duration of 12 weeks, meaning that one study that had been included in previous versions of this review was excluded. The reviewers are aware of susceptibility of post hoc questions to bias (Alderson 2005).

In the previous version of this review, and as specified in the protocol, studies were categorised into long-term (at least one year) and short-term (at least 12 weeks), referring to the length of the intervention itself or to a combination of the intervention with a follow-up phase. For this review update, studies were categorised based on target age group (0-5 years, 6-12 years, and 13-18 years) rather than study duration, to enhance utility of this review for decision makers.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Amaro 2006

Methods

Trial design: Cluster randomised controlled trial

Intervention period: 24 weeks

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Not Reported

Unit of allocation: Classrooms

Unit of analysis: Child (controlling for clustering effect of classroom)

Participants

N (controls baseline) = 103

N (controls follow-up) = 88

N (interventions baseline) = 188

N (interventions follow-up) = 153

Setting: Schools (n = 3; Intervention: 10 classrooms, Control: 6 classrooms)

Recruitment: Middle school students in Naples

Geographic Region: Italy

Percentage of eligible population  enrolled: 95%

Mean Age: Intervention: 12.3 ± 0.8; Control: 12.5 ± 0.7

Sex: Males and females

Interventions

Board game Kaledo to increase nutrition knowledge:

  • 1 play session per week lasting 15-30 minutes with 2 players on each team

  • Players match difference between the total energy intake given by the nutrition cards and the total energy expenditure given by the activity cards

  • At the end of the game the player with the least difference between energy intake and expenditure is the winner

Dietary intervention versus control

Outcomes

Height, weight

Physical activity

Nutrition knowledge

Dietary Intake

Process evaluation: Not reported

Implementation related factors

Theoretical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low risk 
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasLow riskAnalysis controlled for clustering effect of classroom

Baranowski 2003

Methods

Trial Design: Randomised controlled trial
Follow-up: Twelve weeks.
Differences in baseline characteristics: Reported.
Reliable outcomes: Yes for anthropometry and accelerometry.
Protection against contamination: Not reported, but set in two camps.
Unit of allocation: Child
Unit of analysis: Child

All analyses were performed according to intention to treat principles

Participants

N (controls baseline) = 16
N (controls follow-up) = 14
N (interventions baseline) = 19
N (interventions follow-up) = 17

Recruitment: all consenting 8-year old, African American girls = 50th percentile for age and gender BMI, with a parent willing to be involved. Set in Texas, US.

Proportion of eligibles participating: Not stated, but children needed access to Internet

Mean Age: Intervention: 8.3 (SD 0.3); Controls: 8.4 (SD 0.3) years.
Sex: girls only.

Interventions

Set in summer camps and homes, the intervention was delivered by trained personnel in camp and researchers via a website. The intervention was designed to prevent obesity and aimed to increase fruit, vegetable and water consumption, and enhance physical activity. Intervention continued via a website with weekly visits. The pilot also evaluated the feasibility of a larger trial.
Controls received usual camp activities and asked to visit control website once a month.

[Combined effects of dietary interventions and physical activity interventions versus control]

Outcomes

BMI
Waist circumference
Physical maturation
Dual X-Ray Absorptiometry (DEXA) for % Body fat

Physical activity: CSA accelerometer,
a modification of the Self-Administered Physical Activity Checklist (SAPAC),
GEMS Activity Questionnaire (GAQ) computerised

Dietary intake measured by two 24 hour recalls using Nutrition Data System computer programme (NDS-R).

Monitoring website usage.

Process Evaluation: Reported

Implementation related factors

Theoretical basis: Social cognitive theory and family systems theory

Resources for intervention implementation (e.g. funding needed or staff hours required): Not Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race, Education, SES)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Random assignment was conducted in an urn randomisation procedure, through telephone contact to the coordinating centre…"
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskCannot be determined
Selective reporting (reporting bias)High riskDid not report % body fat at follow-up despite noting this as a measure and recording at baseline
Other biasHigh riskStatistically significant differences between groups in BMI at baseline

Beech 2003

Methods

Trial Design: Randomised controlled trial

Intervention period: Twelve weeks

Follow-up period (post-intervention): Nil
Differences in baseline characteristics: Reported
Reliable outcomes: Reported
Protection against contamination: Not reported
Unit of allocation: Child
Unit of analysis: Child

Participants 
Interventions 
Outcomes

Body Mass Index
Waist circumference
Physical maturation
Dual X-Ray Absorptiometry (DEXA) for % Body fat
Blood samples for insulin

Physical activity: accelerometer CSA,
a modification of the Self-Administered Physical Activity Checklist (SAPAC),
GEMS Activity Questionnaire (GAQ) computerised.

Dietary intake measured by two 24 hour recalls using Nutrition Data System computer programme (NDS-R).

Psychological variables:
Body image using modified (Stunkard 1983) body silhouettes. Weight control behaviours using McKnight Risk Factor Survey.
Parental food preparation practices
Self-Perception Profile for Children
Healthy Growth Study for physical activity expectations, and a self-efficacy measure.

Process evaluation: Reported

Implementation related factors 
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"...urn randomization procedure was used to generate the treatment allocation sequences. The different sequences were stored on a computer at the CC, and accessed using an interactive voice-response telephone system." (Rochon 2003)
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low riskno missing outcome data
Selective reporting (reporting bias)High riskDid not report % body fat at endpoint despite noting this as a measure and recording at baseline
Other biasLow risk 

Caballero 2003

Methods

Trial Design: Cluster randomised controlled trial
Intervention period: Three years

Follow-up (post-intervention): Nil
Differences in baseline characteristics: Reported.
Reliable outcomes: Yes
Protection against contamination: Adequately addressed.
Unit of allocation: School
Unit of analysis: Child.
Unit of analysis errors addressed

Primary analysis applied the intention to treat principle and missing data at follow-up was imputed based on a prediction equation developed using control school data and Rubin's multiple imputation method.

Participants

N (controls baseline) = 835
N (controls follow-up) = 682
N (interventions baseline) = 879
N (interventions follow-up) = 727
N of schools: 41
Recruitment: all consenting American Indian students in grades 3 to 5 (8 to 11years) from schools in Arizona, New Mexico, South Dakota, US.

Proportion of eligibles participating: Not stated, but schools had to provide: >15 3rd graders; 90% American Indian; retention of 3-5 grades over 70% in past 3 years; school meals prepared on site; facilities for PA programme; approval of study by school, community and tribal authorities.

Mean Age: 7.6 (SD 0.6) years
Sex: both sexes included but no figures given

Interventions

School-based multi-component trial utilising school curriculum and existing staff resources trained by licensed SPARK (Sports, Play and active Recreation for Kids, see Sallis et al. 1993) instructors and Pathways personnel who also acted as mentors. The intervention aimed to attenuate obesity and reduce percentage body fat.
Four components included improved physical activity, food service, class-room curriculum and family involvement programme.
Control programme not reported, presumably usual curriculum

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes

BMI
Triceps and subscapular Skinfolds.
Bioelectrical impedance.
Physical activity: TriTrac R3D accelerometer, and checklist standardised from pilot work was used as a 24-recall questionnaire.
Knowledge attitudes and beliefs: self report questionnaires developed in pilot.
Dietary intake measured by modified 24-hour recall
Observations of school meals.
Analysis of school menus for energy, protein, carbohydrate, fat, sodium and fibre using the Nutrition Data System computer programme.

Process Evaluation: Reported

Implementation related factors

Theoretical basis: Social learning theory and principles of American Indian culture and practice

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender)

PROGRESS categories analysed at outcome: Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Low riskAssessors were not involved in delivering intervention so as a result were likely blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskMissing data balanced across groups and imputation method given
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasLow riskUnit of analysis issues addressed

Coleman 2005

Methods

Trial design: Cluster randomised controlled trial

Intervention period: 4 years

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Not Reported

Unit of allocation: School

Unit of analysis:  School

All analyses were performed according to intention to treat principles

Participants

N (controls baseline) = 473

N (interventions baseline) = 423

N (interventions follow-up) = 744

Setting [and number by trial group]: 8 schools (n = 4 intervention; n = 4 control)

Recruitment: Intervention schools chosen randomly from schools that had applied to participate in the programme in 1999. Control schools matched by district and geographic location. All children in 3rd grade invited to participate.

Geographic Region: El Paso, Texas - along US-Mexico border region

Percentage of eligible population enrolled: 94%

Mean Age:

Control: 8.3 ± 0.5 years (boys); 8.3 ± 0.5 years (girls)

Intervention: 8.3 ± 0.5 years (boys); 8.2 ± 0.45 years (girls)

Sex

Intervention: 47% female
Control: 47% female

Interventions

Intervention schools: received money ($3500 in first year, $2500 in second year, $1500 for third year and $1000 for fourth year) for purchasing equipment and paying substitutes so that PE teachers and food service staff could attend training, and for promotion of CATCH programme at each school. Classroom materials were also subsidised (CATCH PE guidebook, PE activity box for grades 3 through 5, curriculum material for grades 3 through 5 and the EATSMART manual).

Control schools: did not receive any of the El Paso CATCH programme materials and did not attend any training for the programme. Received $1000 at the start of each school year to encourage participation.

Also received some data i.e. at start of 4th grade, the 3rd grade summary results were provided to both intervention and control schools.

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes
  • Risk of overweight or overweight

  • Anthropometry (height, weight, waist to hip ratio, BMI)

  • Aerobic fitness

  • PE outcomes (time spent in moderate physical activity (goal greater than or equal to 50%), time spent in vigorous physical activity (goal greater than or equal to 20%))

  • Cafeteria outcomes (fat in school lunches (greater than or equal to 30%), sodium in school lunches (goal = 600-1000mg))

Process evaluation: Reported

Implementation related factors

Theoretical basis: Not reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race, Gender, SES)

PROGRESS categories analysed at outcome:  Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk"Participant schools were chosen randomly from those schools that had completed an application to participate" in CATCH programme. Not clear how this was done. Control schools matched and assigned, probably not using randomly generated sequence. Authors describe design as quasi-experimental
Allocation concealment (selection bias)Unclear riskAllocation may have been concealed but it is not clear. There was cluster allocation.
Blinding (performance bias and detection bias)
All outcomes
High riskblinding probably not carried out for participants or outcome assessors
Incomplete outcome data (attrition bias)
All outcomes
Low riskIntention to treat analysis conducted
Selective reporting (reporting bias)High riskIncomplete reporting of outcome data. No anthropometry data at endpoint (authors state no effect but no data provided)
Other biasLow riskSchool-level dependent measures were analysed by group and time

Dennison 2004

Methods

Trial Design: Cluster randomised controlled trial
Intervention period: 12 weeks

Follow-up (Post-intervention): Nil
Differences in baseline characteristics: Not reported.
Reliable outcomes: Reported.
Protection against contamination: Reported
Unit of allocation: Nursery
Unit of analysis: Unclear

Participants

N (controls baseline) = 83
N (controls follow-up) = 73
N (interventions baseline) = 93
N (interventions follow-up) = 90
Setting: School (8 intervention and 8 control)
Geographic Region: New York State, US

Proportion of eligibles participating: Not stated

Mean Age: 4.0 years
Sex: both sexes included but no figures given

Interventions

Preschool and day care centre based intervention delivered by one early childhood teacher and a music teacher. This was part of larger 'Brocodile the Crocodile' health promotion programme which lasted for 39 weeks for 1 hour each week including 32 sessions on healthy eating. Seven educational sessions assessed intervention to encourage reduction of TV viewing for both parents and children.
Controls received materials and activities about health and safety.

Physical activity interventions versus control

Outcomes

BMI
Triceps Skinfolds

Parental estimates of child's sedentary activity in previous week in hours, and to estimate number of hours usually spent in these activities for each weekend day and each week day

Alternate activities as a result of reduced TV viewing were not stated/measured

Process Evaluation: Not Reported

Implementation related factors

Theortetical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race, Occupation, )

PROGRESS categories analysed at outcome: Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Randomisation performed in random permutations of the numbers 1 and 2…"
Allocation concealment (selection bias)Low riskCentres agreed to participate, then randomisation was performed at the centre level on all centres at the start of the study
Blinding (performance bias and detection bias)
All outcomes
High riskNot blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskParticipant flow through study provided and reasons given for missing data
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasHigh riskUnit of analysis issues not addressed

Donnelly 2009

Methods

Trial design: cluster randomised controlled trial

Intervention period: 3 years

Follow-up period (post-intervention): Teachers surveyed  9 months after completion

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Not reported

Unit of allocation: School

Unit of analysis:  Individual; School (correlation between BMI change and weekly PAAC minutes)

All analyses were performed according to intention to treat principles

Participants

N (controls baseline) = 713

N (controls follow-up) = 698

N (interventions baseline) = 814

N (interventions follow-up) = 792

Setting [and number by trial group]: Schools (n = 14 intervention, n = 10 control)

Recruitment: All students in grades 2 and 3 at baseline in participating schools (since it was adopted as a curriculum)

Geographic Region: Northeast Kansas, USA

Percentage of eligible population  enrolled: 92%

Mean Age:

Grade 2: Female (C: 7.8, 0.4; I: 7.7, 0.3); Male (C: 7.8, 0.3; I: 7.7, 0.4)

Grade 3: Female (C: 8.7, 0.4; I: 8.7, 0.4); Male (C: 8.8, 0.4; I: 8.7, 0.3)

Sex: Both Males and Females

Interventions
  • programme promoted 90 min/wk of moderate-to-vigorous physically active academic lessons delivered to children intermittently throughout school day. This is in addition to the existing 60 min/wk PE which would result in a total of 150 min of PA/wk

  • Teacher training: Teacher training was provided as a traditional in-service to teachers in the intervention group at the beginning of the first year, and reviewed in the second and third year. Each in-service comprised a 6-hour day and provided teachers with skills to implement PA fully into the classroom and incorporate PA into their lesson plans. Training also covered organisation and management techniques, observation of student behaviours, safety procedures, active teaching techniques, motivational techniques, and understanding moderate-intensity PA.

Physical activity interventions versus control

Outcomes

BMI

Accelerometry (sub-sample only)

Learning outcomes

Process evaluation: Reported

Implementation related factors

Theoretical basis: Not reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race, Gender, SES)

PROGRESS categories analysed at outcome:  Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Low riskRAs blinded to condition for measurement of primary and secondary outcomes and data entry. RA who conducted classroom visitations not blinded
Incomplete outcome data (attrition bias)
All outcomes
Low risk 
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasLow riskAnalysis conducted at both individual and school level

Ebbeling 2006

MethodsTrial Design: randomised controlled trial
Intervention period: 25 weeks
Follow-up (post-intervention): Nil
Differences in baseline characteristics: Reported
Reliable outcomes: Reported
Protection against contamination: Reported
Unit of allocation: Child
Unit of analysis: Child
Participants

N (controls baseline) = 50
N (controls follow-up) = 50
N (interventions baseline) = 53
N (interventions follow-up) = 53

Setting [and number by trial group]: Home (intervention n = 53; control n = 50)
Recruitment: Local high school provided mailing lists. Adolescents ages 13-18 years who reported consuming at least one serving per day of sugar-sweetened beverage (SSB) and lived predominately in one household were eligible.

Geographic Region: USA

Percentage of eligible population  enrolled: 77%

Mean Age:

Control: 15.8 ± 1.1 years
Intervention: 16.0 ± 1.1 years

Sex:

Control: 54% female
Intervention: 55% female

Interventions

Intervention

  • Weekly home deliveries of noncaloric beverages for 25 weeks: the target number of individual beverage servings (i.e., 360 mL or 12 fl oz per referent serving) delivered to each home was based on household size: 4 servings per day for the subject and 2 servings per day for each additional member of the household. Beverage preferences selected from a wide variety of options (e.g., bottled water and “diet” beverages including soft drinks, iced teas, lemonades, and punches). A regional supermarket delivery service filled the orders and delivered the beverages, with research staff coordinating and monitoring the process

  • Monthly telephone calls to reinforce instructions, provide education and counselling, etc

  • Refrigerator magnets with messages under the theme of “Think Before You Drink and an additional message cautioned subjects to beware of misleading beverage labels and advertisements

Control

  • Subjects in control group asked to continue their usual beverage consumption habits throughout the 25-week intervention period

  • Received weekly home deliveries of noncaloric beverages for 4 weeks after completion of follow-up measurements, as a benefit for having participated in the study

Dietary interventions vs control

Outcomes

BMI
Energy intake from sugar-sweetened beverages
Noncaloric beverage intake (ml)
Physical activity (MET)
Television viewing (hours)
Total media time (hours)

Process Evaluation: Reported

Implementation related factors

Theoretical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race, Gender, SES)

PROGRESS categories analysed at outcome: Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskEligible subjects were entered sequentially onto a list of random group assignments prepared in advance by the study statistician, stratified by gender and BMI. Sequence of random assignments was permutated within stratum in blocks of 2, 4 and 6
Allocation concealment (selection bias)Low riskTo avoid any bias in the enrolment procedure, personnel conducting recruitment were masked to the sequence
Blinding (performance bias and detection bias)
All outcomes
Unclear riskInterviewer for dietary and PA recall interviews was masked to group assignment. Not clear whether people conducting BMI measures (primary endpoint) were masked to group assignment. Participants not masked.
Incomplete outcome data (attrition bias)
All outcomes
Low riskAll participants completed study
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasLow risk 

Epstein 2001

MethodsTrial Design: randomised controlled trial
Intervention period: one year
Follow-up (post-intervention): Nil
Differences in baseline characteristics: Reported
Reliable outcomes: Yes
Protection against contamination: Not clear
Unit of allocation: Child
Unit of analysis: Child
ParticipantsFor percentage of overweight (height and weight measured but not reported)
N (controls baseline) = 13 (low fat/sugar)
N (controls follow-up) =13
N (interventions baseline) =13 (fruit and veg)
N (interventions follow-up) = 13
Two interventions, 13 children in each intervention group. 30 started but only 26 children provided baseline data
Geographic region: New York State, US.
Proportion of eligibles participating: Not stated
Mean Age: 8.8 (1.8) (low fat/sugar); 8.6 (1.9) (fruit/veg)
Sex: both sexes included (boys/girls 6/7 (low fat/sugar); 3/10 (fruit/veg))
Interventions
  • Families with obese parents and non-obese children were randomized to groups in which parents were provided a comprehensive behavioural weight-control programme and were encouraged to increase fruit and vegetable intake.

  • Comparison groups were encouraged to decrease intake of high fat/high sugar foods

Dietary interventions versus control

Outcomes

Percentage of overweight
Servings per day of fruits and vegetables
Servings per day of high fat/high sugar foods

Process Evaluation: Not Reported

Implementation related factors

Theoretical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender)

PROGRESS categories analysed at outcome:  Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing outcome data
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasLow risk 

Fernandes 2009

Methods

Trial design: controlled before and after study

Intervention period: 16 weeks

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported (anthropometric, dietary intake)

Protection against contamination: Contamination likely as there were control and intervention classes within the same school. Teachers of control classes were instructed not to teach about diet and nutrition during the study period.

Unit of allocation: Class

Unit of analysis:  Individual

Participants

N (controls baseline) = 80

N (controls follow-up) = 80

N (interventions baseline) = 55

N (interventions follow-up) = 55

Setting [and number by trial group]: 9 classes within 2 schools (n = 4 classes, intervention; n = 5 classes control)

Recruitment: All schoolchildren enrolled in the 2nd grade at the 2 schools whose parents gave consent and who attended on both data collection days

Geographic Region: Florianópolis, Brazil

Percentage of eligible population  enrolled: 70%

Mean Age:

Control: 8.1 ± 0.48 years

Intervention: 8.2 ± 0.76 years

Sex: Both Males and Females

Interventions

Nutritional education programme delivered via 8 fortnightly meetings (each 50 mins) and taught using learning-through-play teaching methods

Dietary interventions versus control

Outcomes

Prevalence overweight/obese (i.e. BMI <85th percentile)

Number of days on which children ate prohibited foods (0-1 day or 2-3 days) over two dietary recalls

Distribution of children eating certain foods over the two dietary recalls

Process evaluation: Not reported

Implementation related factors

Theoretical basis: learning-through-play

Resources for intervention implementation (e.g. funding needed or staff hours required): Not Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskNot randomised
Allocation concealment (selection bias)High risk 
Blinding (performance bias and detection bias)
All outcomes
High risk 
Incomplete outcome data (attrition bias)
All outcomes
Low risk 
Selective reporting (reporting bias)Unclear riskNo BMI/zBMI presented
Other biasHigh riskFoods provided in schools available to all students and outside of control of students. Different food environment between the 2 schools (public, private). For the food recall results, there are important differences between the results recorded in the text compared with that in the tables (values from the tables have been used for this review where possible).

Fitzgibbon 2005

Methods

Trial design: Cluster randomised controlled trial

Intervention period: 14 weeks

Follow-up period (post-intervention): 2 years

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Not reported

Unit of allocation: preschool

Unit of analysis:  Individual

To assess possible bias in results because of children leaving school or missing anthropometric data at a specific follow-up, two additional analyses were conducted in which authors imputed BMI 1 and 2 years post-intervention from prior (baseline, post-intervention, or Year 1) or subsequent (Year 2) values of BMI.

Participants

N (controls baseline) = 212

N (controls follow-up) = post-intervention (n = 183); 1-year follow-up (n = 146); 2-year follow-up (n = 154)

N (interventions baseline) = 197

N (interventions follow-up) = post-intervention (n = 179); 1-year follow-up (n = 143); 2-year follow-up (n = 146)

Setting [and number by trial group]: Preschools (intervention n = 6; control n = 6)

Recruitment: Twelve Head Start sites administered through the Archdiocese of Chicago and that served primarily African-American children were recruited to participate. All children at these sites were eligible to participate.

Geographic Region: Chicago, USA

Percentage of eligible population  enrolled: Not reported

Mean Age: Intervention: 48.6 ± 7.6 months; Control: 50.8 ± 6.4 months

Sex: Intervention: 49.7% female; Control: 50.5% female

Interventions

Child intervention:

  • 14 weeks (three times weekly) of a diet/physical activity intervention delivered by trained early childhood educators.

  • Each session included:

  • 20min nutrition activity reflecting the food pyramid

  • 20min aerobic activity based on overall moderate/vigorous movement

Parent intervention:

  • Received weekly newsletters that mirrored the children's curriculum

  • Accompanying homework assignments (n=12) designed to be an interactive activity between children and parents. Parents received a small monetary incentive for completing and returning homework.

Control intervention:

  • 14 week (one time weekly) curriculum that taught general health concepts such as seat belt safety, immunisation and dental health.

  • Parents received weekly newsletters that mirrored the curriculum, but no homework assignments

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes

Primary: Change in BMI from baseline to Year 1 post-intervention and Year 2 post-intervention.

Secondary:

  • Dietary intake

  • Physical activity

  • Television viewing

Process evaluation: Reported

Implementation related factors

Theoretical basis: Reported (social cognitive theory as the primary framework,
and concepts from self-determination theory)

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender, Race, Education)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes

Intervention design reported in Fitzgibbon et al Prev Med. 2002;34:289-97.

This study is linked with results reported for another 12 preschools servicing Latino communities in Fitzgibbon et al. Obesity 2006;14:1616-1625.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low riskPerformed adjusted analysis using two different approaches for imputation of missing data and reported both results
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasLow riskAnalysis accounted for clustering by preschool

Fitzgibbon 2006

Methods

Trial design: Cluster randomised controlled trial

Intervention period: 14 weeks

Follow-up period (post-intervention): 2 years

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Not reported

Unit of allocation: Preschool

Unit of analysis:  Individual

All analyses were performed according to intention to treat principles

Participants

N (controls baseline) = 199

N (controls follow-up) = post-intervention (n = 193); 1-year follow-up (n = 165); 2-year follow-up (n = 165)

N (interventions baseline) = 202

N (interventions follow-up) = post-intervention (n = 196); 1-year follow-up (n = 178); 2-year follow-up (n =176)

Setting [and number by trial group]: Preschools (intervention n=6; control n=6)

Recruitment: Twelve Head Start sites administered through the Archdiocese of Chicago and that served primarily Latino children were recruited to participate. All children at these sites were eligible to participate.

Geographic Region: Chicago, USA

Percentage of eligible population  enrolled: Not reported

Mean Age:

Intervention: 50.8 ± 7.3 months

Control: 51.0 ± 7.0 months

Sex:

Intervention: 47.5% female

Control: 51.3% female

Interventions

Child intervention:

  • 14 weeks (three times weekly) of a diet/physical activity intervention delivered by trained early childhood educators.

  • Each session included:

  • 20min nutrition activity reflecting the food pyramid

  • 20min aerobic activity based on overall moderate/vigorous movement

  • Curriculum was linguistically and culturally appropriate and delivered in both Spanish and English

Parent intervention:

  • Received weekly newsletters that mirrored the children's curriculum

  • Accompanying homework assignments (n=12) designed to be an interactive activity between children and parents. Parents received a small monetary incentive for completing and returning homework.

Control intervention:

  • 14 week (one time weekly) curriculum that taught general health concepts such as seat belt safety, immunisation and dental health.

  • Parents received weekly newsletters that mirrored the curriculum, but no homework assignments

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes

Primary: Change in BMI from baseline to Year 1 post-intervention and Year 2 post-intervention.

Secondary:

  • Dietary intake

  • Physical activity

  • Television viewing

Process evaluation: Reported

Implementation related factors

Theoretical basis: Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender, Race, Education)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes

Intervention design reported in Fitzgibbon et al Prev Med. 2002;34:289-97.

This study is linked with results reported for another 12 preschools primarily servicing African-American children in Fitzgibbon et al. J Pediatr 2005;146:618-25.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low riskParticipant flow provided with numbers missing similar between intervention and control groups
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasLow riskAnalysis accounted for clustering by preschool

Foster 2008

Methods

Trial design: Cluster randomised controlled trial

Intervention period: 2 years

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported (anthropometry, dietary intake, PA and sedentary behaviour)

Protection against contamination: All schools were under the direction of the districts Food Service Division, which agreed to make the necessary changes in intervention schools, while making no changes to the control schools.

Unit of allocation: School

Unit of analysis:  Individual

Missing data was imputed using the multiple imputation procedure with the Markov chain Monte Carlo algorithm as well as the last observation carried forward method for comparison

Participants

N (controls baseline) = 600

N (controls follow-up) = 365

N (interventions baseline) = 749

N (interventions follow-up) = 479

Setting [and number by trial group]: Schools (n = 5 intervention, n = 5 control)

Recruitment: Within schools, written parental consent and child assent required.

Geographic Region: Philadelphia, USA

Percentage of eligible population  enrolled: School level: 83%. Across participating schools, consent rate was 70 ± 15%

Mean Age: Intervention: 11.13 ± 1 years; Control: 11.2 ± 1 years

Sex: Intervention: 52% female; control: 55% female

Interventions

SNPI-School Nutrition Policy Initiative - 5 components

school self assessment

  • Assessed environments using the CDC School Health Index

  • School formed a Nutrition Advisory Group to guide assessment

  • Schools subsequently developed an action plan for change with a variety of strategies-eg limiting use of food as reward/punishment, fundraising etc

nutrition education

  • 50 hours of food and nutrition education per student per school year-based on NCES guidelines

  • Integrated into classroom subjects; integrative and interdisciplinary

nutrition policy

  • All food sold and served in the schools was changed to meet the nutritional standards-based on DG for Americans

social marketing

  • Several techniques-raffle tickets; slogan and character development

Family/parent outreach

  • Home and school association meetings, report card nights, parent education meetings,weekly nutrition workshops. Parent challenges re PA and HE.

  • Schools encouraged parents to send healthy foods and discouraged unhealthy foods

Staff training

  • all school staff offered ˜10 hours/yr of training in nutrition education to receive curricula and supporting materials e.g. Planet Health and Know your body, and curriculum lesson packets etc

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes

Incidence of overweight and obesity

Prevalence and remission of overweight and obesity

Dietary intake and Physical Activity

Sedentary behaviours

Potential adverse effects

Process evaluation: Not reported

Implementation related factors

Theoretical basis: Settings-based approach; CDC Guidelines to Promote Lifelong Healthy Eating and Physical Activity.

Resources for intervention implementation (e.g. funding needed or staff hours required): Not Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race, Gender, SES)

PROGRESS categories analysed at outcome:  Reported (Race, Gender)

Outcomes relating to harms/unintended effects: Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low risk 
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasLow riskAnalysis accounting for clustering within schools

Gentile 2009

Methods

Trial design: Cluster randomised Controlled Trial

Intervention period: 8 months (1 academic year)

Follow-up period (post-intervention): 6 months

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Reported

Unit of allocation: School

Unit of analysis:  Individual (with adjustment for school)

Participants

N (controls baseline) = 653       

N (controls follow-up) = 619 (post-intervention), 587 (follow-up)

N (interventions baseline) = 670

N (interventions follow-up) = 582 (post-intervention), 529 (follow-up)

Setting: School (intervention n = 5, Control n = 5)

 Recruitment: Students in 3rd - 5th grade from 10 schools in two States

Geographic Region: USA

Percentage of eligible population  enrolled: 63%

Mean Age:

Intervention: 9.6 (0.9) years

Control: 9.6 (0.9) years

Sex: Both males and females

Interventions
  • The Switch programme promoted healthy active lifestyles by encouraging students to 'Switch what you Do, Chew, and View'. The specific DO, VIEW, and CHEW goals were to be active for 60 minutes or more per day, to limit total screen time to 2 hours or less per day, and to eat five fruits/vegetables or more per day. The intervention utilized overlapping behavioural and environmental strategies employed at multiple ecological levels.

  • Social Marketing: The community component was designed to promote awareness of the importance of healthy lifestyles and the prevention of childhood obesity in the targeted communities, and included paid advertising, (for example, billboards) and unpaid media emphasizing the key messages.

  • Curriculum: The school curriculum component was designed to reinforce the Switch messages and facilitate the family component of the intervention. Teachers were provided with materials and ways to integrate key concepts into their existing curricula.

  • Family: The family component was designed to provide parents (and children) with materials and resources via monthly resource packs sent home to facilitate the adoption of the healthy target behaviours by the family.   

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes

Height and weight, Screen time, fruit and vegetable intake, physical activity (steps)

Process evaluation: Not reported

Implementation related factors

Theoretical basis: Socio-ecological theory

Resources for intervention implementation (e.g. funding needed or staff hours required): Not Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race, Gender)

PROGRESS categories analysed at outcome:  Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskCannot be determined
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasLow riskAnalysis adjusted for clustering within schools

Gortmaker 1999a

Methods

Trial Design: cluster randomised controlled trial
Follow-up: Over two school years (18 months).
Differences in baseline characteristics:
Reported.
Reliable outcomes: Self report outcome measures were developed or modified from existing measures. If not designed for youth sample the measures were validated for use in this sample.
Protection against contamination: Not clear.
Unit of allocation: School
Unit of analysis: Child.
Unit of analysis errors addressed

All analyses were performed according to intention to treat principles. Also used indicator variables with mean substitution to control for missing behavioural data and re-estimated regressions that excluded observations with missing data for sensitivity analyses.

Participants

N (intervention follow-up) = 641
N (control follow-up) = 654
Outcome data collected for: 82% of baseline N enrolled: (81% Intervention and 82% Controls)
65% of eligible population = 1560.
N participants: 1295
N of schools: 10
Setting: School
Geographic Region: Massachusetts, US

Age: mean age 11.7 years
Sex: 48% girls.

Interventions

School-based interdisciplinary intervention utilising the school curriculum and existing school teachers to promote four major subjects and physical education. Sessions focused on decreasing television viewing, decreasing consumption of high-fat foods, increasing fruit and vegetable consumption and increasing moderate and vigorous physical activity.
Control programme not reported, presumably usual school curriculum

Combined effects of dietary interventions and physical activity interventions versus control

OutcomesBody Mass Index
Triceps Skinfold.
Food and activity survey
11-item TV and video Measure
Youth Activity Questionnaire used to measure moderate and vigorous physical activity
Food Frequency Questionnaire used to measure aspects of dietary intake including % energy from fat and saturated fat, fruit and vegetable intake and total energy intake
Process Evaluation: Reported
Implementation related factors

Theoretical basis: Behavioural choice and Social Cognitive Theory

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race, Gender)

PROGRESS categories analysed at outcome: Reported (Race, Gender)

Outcomes relating to harms/unintended effects: Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"… were randomly assigned (using a random number table)…"
Allocation concealment (selection bias)Low riskRandomisation was conducted at school level and all were randomised at start of study. Student intervention status was assigned based on school enrolment.
Blinding (performance bias and detection bias)
All outcomes
Low riskOutcome assessors were blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskMissing data balanced across groups and reasons for missing data given
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasLow riskUnit of analysis issues addressed

Gutin 2008

Methods

Trial design: cluster randomised controlled trial

Intervention period: 3 years

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Not reported

Unit of allocation: School

Unit of analysis:  Individual

All analyses were performed according to intention to treat principles

Participants

N (controls baseline) = 289

N (controls 1 year follow-up) = 265 (for analysis, N = 265)

N (controls 3 year follow-up) = 168 (for analysis, N = 168)

N (interventions baseline) = 312

N (interventions 1 year follow-up) = 260 (for analysis, N = 182)

N (interventions 3 year follow-up) = 148 (for analysis, N = 42)

Setting [and number by trial group]: School (n = 9 intervention; n = 9 control)

Recruitment: All consenting students in participating schools who would be beginning 3rd grade at the start of the intervention.

Geographic Region: Augusta/Richmond County, Georgia, USA

Percentage of eligible population  enrolled: 52%

Mean Age: 8.5 ± 0.6 years

Sex: 52% female

Interventions

2-hour after-school intervention sessions were offered 5 days/wk on school days for 3 school years, however students did not have to attend every day to continue in the programme. The programme included:

  • 40 min of academic enrichment activities, during which healthy snacks were provided (healthy snacks could be construed as a modest dietary intervention) followed by:

  • 80 min of moderate-to-vigorous PA (MVPA), which a variety of activities designed to improve sport skills, aerobic fitness, strength, and flexibility and 40 min were devoted to vigorous PA. The activities were designed to be mastery-oriented rather than competitive.

Control group received regular health screenings and diet/PA  information.

Physical activity interventions versus control

Outcomes

Percent body fat (%BF), bone density, fat mass, fat-free soft tissue (FFST), BMI, waist circumference, cardiovascular (CV) fitness, CV risk factors (total cholesterol, HDL cholesterol, resting blood pressure), self-reported free-living PA, PA enjoyment, motivation for PA, perceived competence, goal orientation.

For reported outcomes at 1 year and 3 years, participants who stayed in the same schools for the intervention period and who returned for all measurements were included. Of these, control participants were compared with intervention participants who had an adequate exposure to the intervention, as indicated by ?40% attendance at the after school sessions (N for analysis reported above).

Process evaluation: Reported

Implementation related factors

Theoretical basis: Environmental change

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race, Gender, Education, SES)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes

Data extracted from 4 publications:

Yin et al. Eval Health Prof 2005;28:67 (intervention rationale, design, process and implementation factors)

Yin et al. Obes Res 2005;13:2153 (1 year outcomes)

Yin et al. Int J Obes 2005;29:S40 (1 year outcomes: post-hoc analysis of dose response relationship between outcomes and level of programme attendance)

Gutin et al. Int J Ped Obes 2008 (3 year outcomes)

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk Sequence generated using random number table
Allocation concealment (selection bias)High risk Performed recruitment over two periods. During the second recruitment period, parents/students were informed of intervention assignment of school. Found no interaction effect of time of consent on primary outcome variables.
Blinding (performance bias and detection bias)
All outcomes
High risk 
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskCannot be determined
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasHigh risk

Analysis was not intention to treat.

Analysis conducting taking clustering into account.

Haerens 2006

Methods

Trial design: cluster randomised controlled trial

Intervention period: Two school years

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Not Reported

Unit of allocation: School

Unit of analysis: Individual

Participants

N (baseline) = 2840 (not available by condition)

N (controls follow-up) =1452

N (interventions follow-up) = 554

Setting: Schools (Intervention: 10 (5 standard intervention, 5 standard intervention + parent support), Control: 5)

Recruitment: Students in seventh and eighth grades from schools with technical and vocational education in West-Flanders

Geographic Region: Belgium

Percentage of eligible population  enrolled: 95%

Mean Age: 13.1(0.8) years (no breakdown by condition)

Sex: Both males and females

Interventions

Two intervention groups:

  • Standard intervention

  • Standard intervention + Parent involvement

The standard intervention comprised:

  • School work group

  • Received background information and guidelines on how to address intervention topics

  • Inervention manual and educational materials

    • Planning and review meetings every 3 months (1-hour)

    • Schools promoted students being physically active during breaks, at noon or during after school hours

    • Resources and sports equipment made available for students

    • Child physical fitness test

    • Computer tailored intervention advice for physical activity and reducing fat intake

  • School promotions, social marketing and educational strategies which focused on three behavioural changes

    • increasing fruit consumption to at least two pieces a day

    • reducing soft drink consumption and increasing water consumption to 1.5L/day

    • reducing fat intake

Parent involvement comprised:

  • Social marketing and educational materials via school papers and newsletters

  • CD with the adult computer-tailored intervention for fat intake and physical activity

  • Encouraged to discuss intervention with children and create supportive home environment for behaviour change

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes
  • BMI z-scores

  • Physical activity (questionnaire and accelerometry for a subset of students)

  • Diet (fat intake, fruit, water and soft drinks; questionnaire)

Process evaluation: Reported

Implementation related factors

Theoretical basis: Reported (Theory of Planned Behaviour, transtheoretical model)

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender, SES)

PROGRESS categories analysed at outcome:  Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
High risk"Pupils not participating at follow-up were significantly older and consumed significantly more soft drinks than pupils participating at follow-up."
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasHigh riskUnit of analysis issues not addressed

Hamelink-Basteen 2008

Methods

Trial design: Controlled clinical trial/cohort analytic

Intervention period: 12 months

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Not Reported

Reliable outcomes: Not Reported

Protection against contamination: Not Reported

Unit of allocation: School

Unit of analysis:  Individual

Participants

N (controls baseline) = 80

N (controls follow-up) = 77

N (interventions baseline) = 393

N (interventions follow-up) = 349

Setting: School (Intervention: 8 , Control:1)

Recruitment: Primary school children from Rhenen (intervention schools) and Elst (control school)

Geographic Region: Netherlands

Percentage of eligible population  enrolled: Intervention: 89%, Control: 96%

Mean Age: children aged 5-6 years (class group 2-3) and aged 9-10 years (class group 6-7)

Sex: Both males and females

Interventions
  • Educational programme led by schoolteacher stimulating consumption of healthy foods (fruit & vegetables) (duration 3 months to 1 year)

  • Educational programme (for schoolchildren, teachers and parents) led by schoolteacher focusing on prevention of overweight. Main themes: breakfast, healthy snacks and exercise (duration 5 wks)

  • Educational programme led by schoolteacher. Main aim to stimulate an active healthy lifestyle  and participating in sports (duration 3 wks)

  • Educational programme led by schoolteacher  involving a (food) shopping game. Aim is to familiarize healthy food shopping (duration: 4 wks)

  • Information evenings (on healthy lifestyle/healthy weight) led by the multidisciplinary project team for both parents and teachers (one eve per school)

  • Weight control course, a preventive educational programme for overweight kids (9 ? 12 yrs only) and their parents. Course consisted of dietary supervision and exercise instructions (instructed by GP/primary care)

Combined effects of dietary interventions and physical activity interventions versus control)

Outcomes

Height, Weight

Nutrition knowledge, diet, behaviours and lifestyle

Process evaluation: Not Reported

Implementation related factors

Theoretical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Not Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Place. Gender)

PROGRESS categories analysed at outcome:  Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskNot randomised
Allocation concealment (selection bias)High risk 
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskCannot be determined
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasUnclear riskCannot be determined

Harrison 2006

Methods

Trial design: Controlled clinical trial/cohort analytic

Intervention period: 16 weeks

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Not Reported

Unit of allocation: School

Unit of analysis:  Individual

Participants

N (controls baseline) = 130

N (controls follow-up) = Not reported (91% successfully followed up)

N (interventions baseline) = 182

N (interventions follow-up) = Not reported (91% successfully followed up)

Setting: School (Intervention: 5, Control: 4)

Recruitment: Children aged 9-11 years from schools in towns and rural areas of the South-East region (disadvantaged)

Geographic Region: Ireland

Percentage of eligible population  enrolled: 99%

Mean Age: Intervention: 10.2 (1.2), Control: 10.3 (0.8) years

Sex: Both males and females

Interventions
  • 10 (30 minute) teacher-led lessons on how children may spend their leisure time and realistic alternatives to TV viewing & computer games usage

  • emphasised self-monitoring, budgeting of time and selective viewing

  • Points system for activity and viewing time.

  • Teacher resources, pupil workbooks and diaries provided, teachers supported by visits every two weeks and parents encouraged in writing to support children

Physical activity interventions versus control

Outcomes

Height, weight

Physical activity and Screen time (measured using a one-day Previous Day Physical Activity Recall (PDPAR)

Physical activity self-efficacy

Aerobic fitness (20m shuttle test)

Process evaluation: Reported

Implementation related factors

Theoretical basis: Social cognitive theory

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender, SES)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskNot randomised
Allocation concealment (selection bias)High risk 
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskCannot be determined
Selective reporting (reporting bias)Low risk 
Other biasLow riskAnalysis conducted taking clustering into account

Harvey-Berino 2003

Methods

Trial Design: randomised controlled trial
Intervention Period: 16 weeks

Follow-Up (Post-intervention): Nil
Differences in baseline characteristics: Reported.
Reliable outcomes: Reported
Protection against contamination: Not reported.
Unit of allocation: Child
Unit of analysis: Child

Participants

N (controls baseline) =20
N (controls follow-up) =17
N (intervention baseline) =20
N (intervention follow-up) =20

Recruitment: Child between the ages of 9 months and 3 years, child was walking, mother BMI >25, mother agreed to keep all appointments. Set in Northern New York State, US, Quebec and Ontario, Canada.

Proportion of eligibles participating: Not stated

Mean Age: 21 months (no SD reported).
Sex: both sexes included; 54% boys.

Interventions

Home visiting programme delivered by an indigenous peer educator who was extensively trained. The intervention was an adaptation of the Active Parenting Curriculum where 11 parenting topics were covered in 16 weeks. The focus for the treatment group was exclusively on how to improve parenting skills to develop appropriate eating and exercise behaviours to prevent obesity.
Controls received the usual parenting support programme

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes

Maternal BMI
N classified >85th and 95th weight for height z (WHZ) centile scores.

Diet: 3 day food records analysed for total calorie and fat intake using Nutritionist IV computer programme.
Physical activity:
Tritrac R3D accelerometer (mother and child)
Psychological variables:
Outcomes Expectations
Self-efficacy
Intentions
Child Feeding Questionnaire

Process Evaluation: Not Reported

Implementation related factors

Theoretical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race, Occupation, Gender, Education)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Low riskOutcome assessors were blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskReasons reported for missing data
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasLow risk 

James 2004

MethodsTrial Design: cluster randomised controlled trial
Intervention period: One year
Follow-up (Post-intervention): Two years
Differences in baseline characteristics: Reported.
Reliable outcomes: Yes
Protection against contamination: Not reported.
Unit of allocation: Class
Unit of analysis: Class
Participants

N (intervention baseline and post-intervention follow-up) 325 (15 classes)
N (intervention 2-year follow-up) = 219

N (control baseline and post-intervention follow-up) = 319 (14 classes)

N (control 2-year follow-up) = 215
No of classes: 29

Outcome data collected for: 100% of sample post-intervention; 67% of sample at 2 year follow-up
% of eligible population enrolled: Not stated

Setting: School
Geographic Region: Southern UK
Age: 8.7 years (range 7 to 10.9 years)
Sex: both sexes included; Controls: 51% girls; Intervention: 48% girls.

Interventions

School-based educational intervention aiming to prevent obesity by reducing consumption of carbonated drinks, delivered by the author and supported by existing staff. Three sessions, one per term, promoted drinking water and a reduction of carbonated drinks.
Control programme not reported, presumably usual school curriculum

Dietary intervention versus controls

Outcomes

Body Mass Index
Proportion of children overweight or obese (based on converting BMI values to centile values and measuring the proportion above the 91st centile)
Carbonated drink consumption and water consumption using a drinks diary

Process Evaluation: Not Reported

Implementation related factors

Theoretical Basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Not Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender)

PROGRESS categories analysed at outcome: Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes

2-year follow-up data reported in:

James et al. Preventing childhood obesity: two-year follow-up results from the Chirstchurch obesity prevention programme in schools (CHOPPS). BMJ 2007;335(7623):762

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"clusters were randomised according to a random number table, with blinding to schools or classes"
Allocation concealment (selection bias)Low risk 
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskLow return rate of drink diaries at baseline and completion
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasLow riskNo unit of analysis issues

Jouret 2009

Methods

Trial design: Controlled before and after study/Cohort analytic

Intervention period: 2 years

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Not Reported

Unit of allocation: Kindergarten

Unit of analysis:  Individual

Participants

N (controls baseline) = 410 (retrospective data)

N (controls follow-up) = 410

N (interventions baseline) = EPIPOI-1: 750; EPIPOI-2: 1030

N (interventions follow-up) = EPIPOI-1: 556; EPIPOI-2: 697

Setting: Kindergartens (79 randomised to either intervention 1 (EPIPOI-1) or intervention 2 (EPIPOI-2) group; 40 matched control kindergartens selected)

Recruitment: Preschool children in Haute-Garonne Department

Geographic Region: France

Percentage of eligible population  enrolled: 51%

Mean Age (mean, SD EPIPOI-1 (3.8, 0.4); EPIPOI-2 (3.7, 0.3); Control (3.9, 0.3)

Sex: Both males and females

Interventions

This study involved two levels of intervention EPIPOI-1 Basic strategy only; EPIPOI-2 Basic plus Education-based reinforcement

Basic strategy

  • Children were assessed (anthropometric measurements) by a physician to identify overweight (BMI ≥90th percentile) and at risk for overweight (BMI between 75th and 90th percentile) children.

  • Parents of overweight and at risk children were advised to take their children to the family physician for treatment. 

  • Physicians of these children were notified to encourage follow-up care and training for obesity treatment was offered to physicians

  • Parents were provided with resources on the consequences of overweight

  • Study physician and a dietician provided information session at participating kindergartens

  • Posters were placed in all participating kindergartens to reinforce the message

Reinforced strategy (provided to intervention group 2; EPIPOI-2)

  • An additional education programme focused on promoting healthy nutrition habits and physical activity and on reducing television watching.

  • A dietician and an education aide conducted ten 20-min sessions of learning activity and games (5 sessions per year) in the classrooms of participating kindergartens.

  • Families were given resources to reinforce the messages and assist with achieving behaviour change

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes

Prevalence of overweight (BMI≥ 90 percentile); weight, height; change in BMI Z-score in relation to age and sex using the French curves

Process evaluation: Not reported

Implementation related factors

Theoretical basis: Not reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Not reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Place, Gender, S-for SES)

PROGRESS categories analysed at outcome:  Reported (Place, S-for SES)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskNot randomised - used historic control group
Allocation concealment (selection bias)High risk 
Blinding (performance bias and detection bias)
All outcomes
Unclear riskHistoric control group
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskCannot be determined
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasLow riskUnit of analysis issues were addressed

Kain 2004

Methods

Trial Design: CCT (cluster case controlled trial)

Intervention period: Six months

Follow-up (post-intervention): Nil
Differences in baseline characteristics: Reported.
Reliable outcomes: Yes
Protection against contamination: Not clear.
Unit of allocation: School
Unit of analysis: Unclear

Participants

N (Intervention and control at baseline) = 2375 N (intervention follow-up) = 2141;
N (control follow-up) =945.

N of schools: 5
(Authorities assigned schools to intervention on basis of need; boys had higher BMIs in intervention schools at baseline).
Outcome data collected for: 100% of sample.
% of eligible population enrolled: Not stated.

Setting: School
Geographic Region: Chile.

Age: 10.6 (SD 2.6)
Sex: both sexes included; Controls: 52% boys; Intervention: 53.5% boys.

Interventions

School-based multi-component intervention aimed to change adiposity and physical activity levels, delivered by a nutritionist and a Physical Education (PE) teacher. Nutrition education was available for children and parents supported by healthier food kiosks. Sessions included 90 minutes additional physical activity weekly for 3rd to 8th grade for 6 months and 15minutes of activity in recess per day, for last 3 months.
Control programme not reported, presumably usual school curriculum

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes

Body Mass Index
Triceps Skinfolds
Waist Circumference

Fitness:
Shuttle run test (20m Leger and Lambert test)
Sit and reach for lower back flexibility

Process Evaluation: Reported

Implementation related factors

Theoretical Basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender)

PROGRESS categories analysed at outcome: Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskNot randomised
Allocation concealment (selection bias)High risk 
Blinding (performance bias and detection bias)
All outcomes
High riskNot blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskReasons for missing data given
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasHigh risk

Group assignment was made according to perception of overweight prevalence and willingness of the schools director to accept a research study. Boys in intervention schools had higher BMIs at baseline.

Unit of analysis issues not addressed

Keller 2009

Methods

Trial design: Randomised Controlled Trial

Intervention period: 12 months

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: N/A

Reliable outcomes: N/A

Protection against contamination: N/A

Unit of allocation: Individual

Unit of analysis: Individual

Participants

N (controls baseline) = 185

N (controls follow-up) = 134

N (interventions baseline) = 59

N (interventions follow-up) = 49

Setting: Home

Recruitment: The network CrescNet collected data (patient height and weight) from more than 300,000 children and 365 were selected at risk of obesity (age 4 to 7 years) to participate

Geographic Region: Germany

Percentage of eligible population  enrolled: 33%

Mean Age: Intervention: 5.9 ± 1.4; control: 5.6 ± 1.2

Sex: Both males and females

Interventions
  • The paediatrician carried out a low threshold intervention which consisted of an age-adapted nutrition and exercise programme to inspire the awareness of the adequate nourishment and motion

  • Three-monthly measurement of height and weight by paediatrician and consultation about aims to change life style (diet and exercise) and progress to targets  based on results of questionnaire (physical activity) and food diaries

  • Three food diaries over period of 12 months, each for 5 days including one weekend.  Dietician passed recommendations for dietary change (based on food diaries) to paediatrician for consultation with family and child

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes

Height, weight

Diet

Process evaluation: N/A

Implementation related factors

Theoretical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): N/A

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender)

PROGRESS categories analysed at outcome:  Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskCannot be determined
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasUnclear riskCannot be determined

Kipping 2008

Methods

Trial design: pilot cluster randomised controlled trial

Intervention period: 5 months

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Not reported

Unit of allocation: School

Unit of analysis:  Individual (analysed both with and without taking clustering within schools into account)

All analyses were performed according to intention to treat principles

Participants

N (controls baseline) = 256 (for BMI)

N (controls follow-up) = 223 (for BMI)

N (interventions baseline) = 275 (for BMI)

N (interventions follow-up) = 249 (for BMI)

Setting [and number by trial group]: Schools (n=10 intervention; n = 9 control)

Recruitment: Children were recruited from year 5 classes in 19 primary schools.

Geographic Region: South Gloucestershire, England

Percentage of eligible population enrolled: 70% of invited schools; 78% of eligible children within participating schools.

Mean Age:

Intervention 9.4 (0.5) years

Control 9.4 (0.49) years

Sex:

Intervention 49.6% female

Control 54.7% female

Interventions

The programme was adapted from the Eat Well Keep Moving programme implemented in the US.

  • 16 lessons on healthy eating, increasing PA and reducing TV viewing

  • Changes from original programme included shortening the lesson plans, change US phrasing or references and change pyramid structure of food groups to the balance of good health. The pilot also did not include two staff meetings.

  • Two teachers provided a training session for 10 teachers who would be delivering the sessions.

  • Materials provided to the schools, including lesson plans for 9 PA lessons, 6 nutrition lessons and one screen viewing sessio

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes
  • Primary outcome: reduction in time spent doing screen-based activities

  • Other outcomes:

    • BMI

    • Obesity

    • Walks/cycles to and from school also included since there was a difference between groups at baseline.

  • Numbers included in final analysis:

    • Intervention: BMI 75%, screen questionnaire 48% and activity questionnaire 51%

    • Control: BMI 64%, screen questionnaire 47% and activity questionnaire 61%

Process evaluation: Reported

Implementation related factors

Theoretical basis: Social cognitive theory and behavioural choice theories

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender)

PROGRESS categories analysed at outcome:  Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not reported (however cost of intervention materials was included)

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Low riskAllocation was at the school level and all schools allocated at the start of the study, after schools were invited to participate and notified that they would be allocated to either intervention or control groups.
Blinding (performance bias and detection bias)
All outcomes
Low riskOutcome assessors and analysts were blinded
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskCannot be determined
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasLow riskClustering taken into account in analyses

Lazaar 2007

Methods

Trial design: Cluster randomised controlled trial

Intervention period: 6 months

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Not Reported

Unit of allocation: School

Unit of analysis:  Individual

Participants

N (obese: controls baseline) = 41

N (obese: controls follow-up) = Not Reported*

N (non obese: controls baseline) = 187

N (non obese: controls follow-up) = Not Reported*

N (obese: interventions baseline) = 59

N (obese: interventions follow-up) = Not Reported*

N (non obese: interventions baseline) = 138

N (non obese: interventions follow-up) = Not Reported*

*Data at 6 months collected from 98.9% of study participants overall. Numbers are not reported by group.

Setting [and number by trial group]: School (intervention n = 14; control n = 5). Intervention and control groups were further divided into obese (BMI>97th percentile) and non obese children to give a total of 4 trial groups (2 x intervention and 2 x control)

Recruitment: Children from participating local state schools were eligible if they were in their first or second grade of elementary school, participating in the scheduled school physical education classes, participating in less than 3h of extra-school sports activity per week, free of any known disease and not participating in other studies.

Geographic Region: France

Percentage of eligible population  enrolled: Not Reported

Mean Age: 7.4±0.8 years (not reported by group)

Sex: 50% female (not reported by group)

Interventions

Control: All children took part in scheduled school physical education (SPE) classes:

  • Two 1-hour sessions each week held within the school timetable

  • Aimed at providing children with a rational basis for their activity programmes and for exercise in general

  • Various combinations of 5min exercises: exercises on coordination, exercises devoted to posture and balance, relaxation techniques, rhythm and music, exercises devoted to creative movement, games relating to group participation etc.

  • Activities increased in intensity and duration throughout the study

Intervention: children in the intervention group were required to follow an additional physical activity (PA) programme:

  • Two 1-hour sessions each week held after class

  • Objective: a playful physical practice and 45min of dynamic exercise within the hour

  • Exercise programme designed to enhance the joy of movement, body awareness and team spirit

  • Based on traditional games aimed at minimising children's inactivity

  • During a session, two children were randomly selected to monitor their energy expenditure and estimate the average intensity of the sessions and quantify the total duration of PA

Physical activity interventions versus control

Outcomes

Primary: Obesity status

Secondary:

  • BMI

  • BMI z-score

  • Waist circumference

  • Skinfold thickness

  • Fat free mass

Process evaluation: Reported

Implementation related factors

Theoretical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Not Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender)

PROGRESS categories analysed at outcome:  Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskA draw was carried out to choose intervention schools
Allocation concealment (selection bias)Low riskAll eligible children from within schools were automatically assigned to groups based according to school assignment and based on their individual BMI
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low risk 
Selective reporting (reporting bias)Unclear riskNo protocol available
Other biasHigh riskUnit of analysis issues not addressed

Macias-Cervantes 2009

Methods

Trial design: Randomised Controlled Trial

Intervention period: 12 weeks

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Not Reported

Unit of allocation: Individual

Unit of analysis: Individual

Participants

N (controls baseline) = 38

 N (controls follow-up) = 30

N (interventions baseline) = 38

N (interventions follow-up) =32

Setting: Home

Recruitment: Children aged 6-9 years attending public schools in four neighbourhoods in León, Guanajuato, Mexico

Geographic Region: Mexico

Percentage of eligible population  enrolled: Not Reported

Median Age: Control: 7.5 (6.9-8.4);  Intervention: 8 (6.1-9.1)

Sex: Both Males and Females

Interventions

Intervention children were instructed to modify their physical activity to obtain an increase of at least 2,500 steps per day over the baseline level. To attain this, two strategies were used:

(a) to increase incidental physical activity (i.e., walk to school, to accompany their parents at shopping and to help in the domestic work at home

(b) involvement in recreational activities three times per week in a Municipal Sport Center (60 min sessions of age-appropriate recreational activities)

Physical activity interventions versus control

Outcomes

Anthropometric measurements: height, weight, waist circumference, triceps skinfold

Laboratory measurements: glucose, triglycerides, cholesterol, HDL-C, LDL-C, HOMA-IR

Basal physical activity (steps/day, by pedometer)

Cardiovascular fitness (VO2 max): by treadmill

Food intake

 

Process evaluation: Reported

Implementation related factors

Theoretical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Not Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Low riskNot blinded but unlikely to influence results
Incomplete outcome data (attrition bias)
All outcomes
Low risk 
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasHigh risk 

Marcus 2009

Methods

Trial design: Cluster Randomised Controlled Trial

Intervention period: 4 years

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported (anthropometry and accelerometry)

Protection against contamination: Not reported

Unit of allocation: School

Unit of analysis: Child

Primary analysis used observed cases, but sensitivity analyses were carried out using FAS population (evaluated with replacement for missing data by last observation carried forward)

Participants

N (controls baseline) = 1465

N (controls follow-up) = 1300

N (interventions baseline) = 1670

N (interventions follow-up) = 1538

Setting: Schools (n = 5 intervention, n = 5 control)

Recruitment: All consenting students in selected schools up to 4th school year

Geographic Region: Sweden

Percentage of eligible population  enrolled: 90% to 100%

Mean Age: Control: 7.5 (1.3) years; Intervention: 7.4 (1.3) years

Sex: both sexes included

Interventions
  • Intervention was designed to change the school environment to promote healthy eating and physical activity during school and in after school care. 

  • Daily physical activity (30 min per child) was integrated into regular school curriculum and facilitated by classroom teachers

  • Classroom teachers encouraged healthy eating, eating less sweetened foods,  and to chose healthy items for school lunch and afternoon snack (provided by schools)

  • School changes in items provided to increase healthiness (lower sugar, more fibre, lower fat etc), eliminate unhealthy celebration foods and restrict foods for excursions and sports days

  • Awareness raising activities included STOPP newsletter to parents and schools twice a year

  • School nurses were also trained in obesity-related problems

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes
  • Prevalence overweight/obese

  • Physical Activity, accelerometer

  • Eating habits

Process evaluation: Reported

Implementation related factors

Theoretical basis: Not reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Not reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline:  Reported (Place, Race, Occupation, Gender, Education, Social status)

PROGRESS categories analysed at outcome:  Reported (Gender. Education)

Outcomes relating to harms/unintended effects: Reported

Intervention included strategies to address diversity or disadvantage: Not reported

Economic evaluation: Not reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskCannot be determined
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasLow riskUnit of analysis issues addressed.

Mo-Suwan 1998

MethodsTrial Design: Cluster randomised controlled trial
Intervention period: 29.6 weeks
Follow-up (post-intervention): 6 months
Differences in baseline characteristics: Reported.
Reliable outcomes: All measures validated in children over 6 years of age.
Protection against contamination: Not clear.
Unit of allocation: Class
Unit of analysis: Child.
Unit of analysis errors addressed.
Participants

Follow-up at 6 months:
N (intervention baseline) = 158
N (intervention follow-up) = 147
N (control baseline) =152
N (control follow-up) = 145
N of classes: 10

Outcome data collected for:
94% of baseline N followed up
75% of eligible population enrolled = 310
Geographic setting: Thailand.

Age: 4.5 (SD 0.4) years
Sex: both sexes included; Controls: 61% boys; Intervention: 56% boys.

Interventions

Kindergarten-based physical activity programme conducted by specially trained staff and including a 15 minute walk and a twenty minute aerobic dance session 3-times a week. Study objective was to evaluate the effect of a school-based aerobic exercise programme on the obesity indexes of preschool children.
Control programme not reported, presumably usual school curriculum

Physical activity interventions versus control

Outcomes
  • Body Mass Index

  • Triceps Skinfold (TSF)

  • WHCU (ratio of wt in kg divided by ht cubed in meters)

  • Computation of BMI, WHCU and TSF slopes

Process Evaluation: Not Reported

Implementation related factors

Theoretical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Not Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender, SES)

PROGRESS categories analysed at outcome: Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow-up was minimal and reasons given for 2 exclusions from analysis
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasLow riskUnit of analysis issues addressed

Müller 2001

MethodsTrial Design: Cluster randomised controlled trial
Intervention period: 1 school year
Follow-up (post-intervention): unclear (still ongoing - further follow-up to be done at 4 and 8 years)
Differences in baseline characteristics: Reported
Reliable outcomes: Reported
Protection against contamination: Not done (Every alternating year schools change and control schools become intervention schools and intervention schools become control schools).
Unit of allocation: School
Unit of analysis: Child.
Not known if unit of analysis errors addressed.
Participants

For weight, height and TSF
N (controls baseline) = 161
N (controls follow-up) = 161
N (interventions baseline) = 136
N (interventions follow-up) = 136
N of schools: 6

Recruitment: all consenting school pupils aged 5-7 years. General recruitment took place as part of health examinations by the school physicians.

Geographical setting: Kiel, Germany.
Proportion of eligibles participating: 30.2 %
Mean Age:
Not reported (children aged 5-7 years)
Sex: both sexes included but not reported for the 297 (136 + 161) children followed up for weight, height and skin fold thickness.

Interventions

School-based intervention which included an 8 hour course of nutrition education including 'active' breaks was given by a skilled nutritionist and a trained teacher. The course included the following messages: 'eat fruit and vegetables each day', 'reduce intake of high fat foods', keep active at least 1 hour each day', 'decrease TV consumption to less than 1 hour per day'.
(In addition a family-based intervention plus a structured sports programme were offered to families with overweight or obese children and to families with normal weight children but obese parents).
The controls received usual schooling during this time period but will cross-over every alternate year.

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes
  • Body Mass Index

  • Triceps skinfold thickness

  • % fat mass of overweight children

  • Nutrition knowledge

  • Daily physical activities

  • Daily fruit and vegetable consumption

  • Daily intake of low fat food

Process Evaluation: Not Reported

Implementation related factors

Theoretical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race, Occupation, Gender, Education, Social status)

PROGRESS categories analysed at outcome: Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskNot reported for school intervention. Family intervention was not randomised.
Allocation concealment (selection bias)High risk 
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
High riskLow completion rate for family intervention (25%) with no reasons given or exploration of differences between completers and non-completers
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasHigh risk"Every alternating year schools changed and the 'control' schools became 'intervention' schools and vice versa." This will affect all outcome measures due to carryover effects of the intervention. Unit of analysis issues not addressed.

NeumarkSztainer 2003

MethodsTrial Design: Cluster randomised controlled trial
Intervention period: 16 weeks + 8 weeks maintenance
Follow-up: Eight months
Differences in baseline characteristics: Reported
Reliable outcomes: Yes for weight, height, TSF (but method of measurement not reported).
Protection against contamination: Not done.
Unit of allocation: School
Unit of analysis: Child.
Not known if unit of analysis errors addressed.
Participants

N (intervention baseline) = 89
N (intervention follow-up) = 84
(3 high schools)
N (control baseline) = 112
N (control follow-up) = 106
(3 high schools)
Outcome data collected for all those enrolled i.e. 100% follow-up
% of eligible population enrolled = 86.8% of intervention school, 83.6% of control school.

Geographical setting;
Minnesota, US.

Mean Age: Intervention: 14.9 (SD0.9) years: Controls: 15.8 (SD1.1).
Sex: girls only

Interventions

High-school based girls only, intervention with priority given to girls with BMI at or above 75th percentile and who did less than 30 minutes per day 3 times per week physical activity (eating disorders excluded). Delivery was by school staff and research team, with local guest instructors. Intervention addressed socio-environmental, personal and behavioural factors, with physical activity four times per week, nutrition and social support session every other week for total of 16 weeks with an 8 week maintenance component of lunch time meetings.
Control programme not reported, presumably usual school curriculum

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes
  • Body Mass Index

  • Physical activity Stages of change (based on the Stages of Change Model)

  • Participation in physical activity based on Godin and Sheppard

  • Dietary intake adapted from Youth and Adolescent Food Frequency Questionnaire

  • Binge eating adapted from the Minnesota Adolescent Health Survey

  • Personal Factors

    • Harter's Self Perception Profile for Children

    • Media internalisation

    • Self-efficacy to be active

    • Socio-environmental support

Process Evaluation: Reported

Implementation related factors

Theoretical basis:Reported (Social Cognitive Theory)

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race, Gender)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)High riskGirls were recruited after the schools were randomised. Girls in intervention schools knew they were enrolling in an alternative physical education class. Girls in control schools were recruited to participate in a research study about eating and exercise patterns of teens.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low riskReasons for missing data given and missing data balanced across groups and with similar baseline characteristics to completers.
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasHigh risk

Girls in the intervention group had higher BMI values than girls in control group, although not statistically significant.

Unit of analysis issues not addressed.

Paineau 2008

Methods

Trial design: Cluster randomised Controlled Trial

Intervention period: 8 months

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Not reported

Unit of allocation: School

Unit of analysis:  Family/Individual

All analyses were performed according to intention to treat principles. Missing data for BMI were imputed using the mean value in the whole cohort.

Participants

N (controls baseline) = 418 families

N (controls follow-up) =  393 children 394 adults

N (intervention A [reduce fat, increase high-complex carbohydrates] baseline) = 297 families

N (intervention A follow-up) = 280 children 280 adults

N (intervention B [reduce both fat and sugar and to increase complex carbohydrates]  baseline) = 298 families

N (intervention B follow-up) = 274 children 275 adults

Setting [and number by trial group]: School ( intervention, control)

Recruitment: Particpants recruited from 54 schools.  In each family, one second- or third-grade pupil (aged 7-9 years) and one of his or her parents participated.

Geographic Region: France

Percentage of eligible population  enrolled: <10%

Mean Age:

Children: Intervention A 7.7 (0.6) , Intervention B 7.8 (0.6), Control  7.6 (0.6)

Parents: Intervention A 40.4 (5.3), Intervention B 40.3 (5.4) , Control 40.6 (5.4)

Sex: Both males and females

Interventions

Intervention group A received advice on how to reduce dietary fats (<35% of total energy intake) and how to increase complex carbohydrates (>50% of total energy intake);Intervention group B received advice on how to reduce both dietary fats (<35% of total energy intake) and sugars (-25% of initial crude intake) and how to increase complex carbohydrates (>50% of total energy intake)

  • Computer based interventions: through the ELPAS website, participant families can access to self-administered questionnaires (diet, PA, meal preparation, and quality of life) along with updated information, an individual and interactive agenda, an email address, and various other functions. They also performed 3-day dietary records

  • Monthly telephone counselling and internet-based monitoring to families (30 min/month) by a trained dietician for 8 months.  The telephone calls were dedicated to analyzing food habits and providing advice on reaching their specific dietary targets

  • Monthly newsletters, to both children and parents

  • Series of events (e.g., conferences, museum visits), and 3 school-based lessons on nutritional education were programmed in participating schools

 

Dietary interventions versus control

Outcomes

Dietary intake: total energy intake, fats, sugars, complex carbohydrates; Anthropometric measures: height, weight, BMI, z BMI,  chest, waist, hip and knee circumferences, blood pressure, heart rate, fat mass, fat free mass, overall physical activity: daily screen viewing and activities for clubs

 

Process evaluation: Not reported

Implementation related factors

Theoretical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Not Reported (Occupation, Gender, Race, Education, S for SES)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation performed according to a computer-generated randomisation list
Allocation concealment (selection bias)Low riskRandomisation occurred at the school level and performed on all units at start of study
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskCannot be determined
Selective reporting (reporting bias)Unclear riskNo protocol available
Other biasHigh riskUnit of analysis issues not addressed

Pangrazi 2003

Methods

Controlled before and after study (CBA)
Intervention period: Twelve weeks

Follow-up (post-intervention): Nil
Differences in baseline characteristics: Not reported.
Reliable outcomes: Reported
Protection against contamination: Adequately addressed
Unit of allocation: School
Unit of analysis: Group
Not known if unit of analysis errors addressed

Participants

N at baseline 606
N of controls and treatment group not reported

Recruitment: all consenting 4th grade children in 35 schools in Arizona, New Mexico, US.

Proportion of eligibles participating: Not stated, but restricted to 4th graders (9 to10 years) as they would not know about PLAY.

Mean Age: 9.8 (SD 0.6) years
Sex: both sexes included (Controls: 57% girls; Intervention: 50.5% girls)

Interventions

School based intervention aimed at increased physical activity with a secondary intention of preventing obesity and delivered by school staff who were specially trained. There were three conditions and a control: 1) PLAY (9 schools); 2) PLAY and PE (10 schools); 3) PE only (10 schools). The intervention has three elements: to promote play behaviour, followed by teacher directed activities and then self-directed activity was encouraged. This was achieved by incorporating 15 minutes of daily activity in the school day and encouraging 30 minutes of out of school play by the end of the intervention.
Controls attended schools (N = 6) with no PE provision

Physical activity interventions versus control

Outcomes
  • Body Mass Index

  • Physical activity: CSA accelerometer

Process evaluation: Not Reported

Implementation related factors

Theoretical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender)

PROGRESS categories analysed at outcome: Reported (Gender)

Outcomes relating to harms/unintended effects: Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskNot randomised
Allocation concealment (selection bias)High riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
High riskNot blinded
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskBaseline data not reported, Group Ns not reported
Selective reporting (reporting bias)High riskBaseline data not reported, Group Ns not reported
Other biasHigh risk

Schools were stratified into groups based on their participation in PLAY and/or the existence of a PE programme (the intervention groups of interest). Participating schools were selected from within these groups, so they were already motivated and participating in the program, and were followed over time. The No Treatment group (control) was comprised of schools who did not have PLAY or a PE programme already in place.

Unit of analysis issues not addressed.

Pate 2005

Methods

Trial design: Cluster randomised controlled trial

Intervention period: 12 months

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Not Reported

Unit of allocation: School

Unit of analysis:  School

Missing data at follow-up were imputed by applying a regression method.

Participants

N (controls baseline) = 741

N (controls follow-up) = 712-741

N (interventions baseline) = 863

N (interventions follow-up) = 827-863

Setting [and number by trial group]: School (intervention n = 12; control n = 12)

Recruitment: All eighth-grade girls who attended 1 of the 31 middle schools that fed students to the 24 participating high schools were invited to complete the measures.

Geographic Region: 14 South Carolina counties

Percentage of eligible population  enrolled: 34%

Mean Age:

Intervention: 13.6±0.6 years

Control: 13.6±0.6 years

Sex: 100% female

Interventions

LEAP (Lifestyle Education for Activity Programme)

Designed to change both instructional practices and school environment to increase support for PA among girls

Instructional:

  • Changes in content and delivery of physical education and health education

  • Included a gender-specific , girl-friendly, choice-based instructional programme designed to build activity skills and reinforce participation in PA, both inside and outside of class

  • Health education lessons to teach skills necessary for adopting and maintaining a physically active lifestyle

Environmental:

  • Role modelling by faculty and staff

  • Increased communication about PA

  • Promotion of PA by the school nurse

  • Family- and community-based activities

Physical activity interventions versus control

Outcomes

Primary outcome: % of girls in who reported participating in vigorous physical activity

Secondary outcomes: prevalence of overweight and at-risk for overweight

Process evaluation: Not Reported

Implementation related factors

Theoretical basis: Reported (Socio-ecological model drawn from Social Cognitive Theory)

Resources for intervention implementation (e.g. funding needed or staff hours required): Not Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race)

PROGRESS categories analysed at outcome:  Reported (Race)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low risk 
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasLow riskNo unit of analysis issues

Patrick 2006

Methods

Trial design: Randomised controlled trial

Intervention period: 12 months

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Not Reported

Unit of allocation: Individual

Unit of analysis:  Individual

Analyses were conducted under the intent-to-treat assumption by replacing missing values at the 12-month end point with the most recent available data from either the 6-month or baseline assessment.

Participants

N (controls baseline) = 395

N (controls follow-up) = 334

N (interventions baseline) = 424

N (interventions follow-up) = 356

Setting [and number by trial group]: Community (intervention n = 424; control n = 395)

Recruitment: Healthy adolescents scheduled for a well child visit were recruited through their primary care providers (n = 45 primary care providers) from 6 private clinic sites

Geographic Region: San Diego County, California, USA

Percentage of eligible population  enrolled: 59%

Mean Age:

Intervention: 12.8 ± 1.3 years (girls); 12.6 ± 1.4 years (boys)

Control: 12.6 ± 1.4 years (girls); 12.8 ± 1.3 years (boys)

Sex: 53% female

Interventions

PACE+ intervention: designed to promote adoption and maintenance of improved eating and PA behaviours

  • computer-supported intervention initiated in primary health care settings

  • printed manual to take home

  • 12 months of stage-matched telephone calls and mail contact

  • parent intervention to help parents encourage behaviour change

Control

  • adaptation of SunSmart sun protection behaviour programme developed at the University of Rhode Island, Kingston

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes

Primary outcomes

  • Minutes per week of moderate plus vigorous physical activity measured by self-report and accelerometer

  • self-report of days per week of physical activity and sedentary behaviours

  • percentage of energy from fat and servings per day of fruits and vegetables (24-hr diet recalls)

Secondary outcomes

  • BMI

Process Evaluation: Not Reported

Implementation related factors

Theoretical basis: Reported (Behavioural determinants model; Social Cognitive Theory; Transtheoretical model behaviour of change)

Resources for intervention implementation (e.g. funding needed or staff hours required): Not Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race, Gender. Education)

PROGRESS categories analysed at outcome:  Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod for sequence generation not reported
Allocation concealment (selection bias)Unclear riskMethod for allocation concealment not reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants were not blinded. Not reported whether or not outcome assessors were blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low riskParticipant flow through study reported and similar rates of attrition across groups
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasLow risk 

Peralta 2009

Methods

Trial design: Randomised Controlled Trial

Intervention period: 6 months

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Not Reported

Reliable outcomes: Reported

Protection against contamination: Not Reported

Unit of allocation: Child

Unit of analysis: Child

All analyses were performed according to intention to treat principles

Participants

N (controls baseline) = 17

N (controls follow-up) = 16

N (interventions baseline) =16

N (interventions follow-up) = 16

Setting [and number by trial group]: Secondary school (n = 1)

Recruitment: 7th Graders completing less than 49 laps using Multistage Fitness Test

Geographic Region: Australia

Percentage of eligible population  enrolled: 58%

Mean Age: 12.5 ± 0.4 years

Sex: Males only

Interventions
  • Curriculum component: 1 x 60-min minute curriculum session and two2x 20-minminute lunchtime physical activity sessions per week, and for 16 programme weeks; Each 60-min curriculum session included practical and/or theoretical components

  • Practical component: comprised of modified games and activities.

  • Theoretical components: focused on promoting physical activity through increasing physical self-esteem and, self-efficacy, reducing time spent in small screen recreation at weekends, decreasing sweetened beverage consumption, and increasing fruit consumption and the, acquisition and practice of self-regulatory behaviours such as goal setting, time management, and identifying and overcoming barriers.

  • Behaviour modification techniques (e.g. group goals converting time spent in physical activity to kilometres to reach a specified destination, and the use of incentives such as small footballs) were used throughout the programme behaviours.

  • Practical components: modified games and activities.

  • School staff, PE teacher,Facilitated by researcher but included programme champion who also chose peer facilitators (11th graders), one 20-min training session) and 6x newsletters sent to parents were also involved except for researchers.

[Combined effects of dietary interventions and physical activity interventions versus control]

Outcomes

Height and weight, Waist circumference, percentage body fat, cardiorespiratory fitness, physical activity using accelerometry, time spent using small screen recreation and sweetened beverage and fruit consumption

 Process evaluation: Reported

Implementation related factors

Theoretical basis: Reported (Social Cognitive Theory)

Resources for intervention implementation (e.g. funding needed or staff hours required): Not Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

NotesAll analyses performed according to intention to treat principles
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskrandomised "using a computer-based number producing algorithm..."
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Low riskAssessors blinded
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskCannot be determined
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasLow riskIntervention conducted in one school with an absence of a "true" control group since it was compulsory for all boys to participate in physical activity

Reed 2008

Methods

Trial design: Cluster randomized Controlled Trial

Intervention period: 1 school year

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Not Reported

Reliable outcomes: Reported

Protection against contamination: Not Reported

Unit of allocation: School

Unit of analysis: Individual

Participants

N (controls baseline) = 90

N (controls follow-up) = 81

N (interventions baseline) = 178

N (interventions follow-up) = 156

Setting: 10 participating schools randomised, 3 assigned to usual practice and 7 assigned to intervention. Of the 10 schools, 2 from the usual practice group and 6 from the intervention group took part in cardiovascular assessment.

Recruitment: Elementary schools in Vancouver and Richmond school districts, British Colombia, Canada; 4th and 5th grade children

Geographic Region: Canada

Percentage of eligible population  enrolled: 52%

Mean Age: 9-11 years

Sex: Both males and females

Interventions
  • The goal of the programme (Action Schools! BC) was to provide 150 min of physical activity per week (2x40 min PE classes and 15x5 min/day of extra physical activity in class throughout the day)

  • The model emphasised a whole-school approach that targeted 6 Action Zones: i) school environment, ii) scheduled physical education, iii) extra-curricular activities, iv) school spirit, v) family and community, and vi) classroom action.

  • Classroom Action was the only prescriptive component and required teachers in the intervention group to deliver 15 min of moderate to intensive physical activity daily to achieve the 75 min of extra physical activity per week in addition to the PE classes.

  • An intervention facilitator worked with the school Action Team (comprised of the school principal and/or teachers) to design a programme that included activities across all 6 Action Zones.

  • A Support Team conducted a 1-day training workshop for teachers in the intervention group to support their action plan. Intervention teachers were also provided a Classroom Action Bin with resources to support their Action Plan.

  • Teachers in both intervention and usual practice (control) groups were asked to record the minutes of physical activity per day in Activity Logs.

Physical activity interventions versus control

Outcomes

Outcome measures: Cardiovascular fitness (measured by 20-m shuttle run test), blood pressure (systolic and diastolic), BMI, total cholesterol, HDL, LDL, Apo B, C-reactive protein and fibrinogen at the end of the intervention period.

Process evaluation: Not Reported

Implementation related factors

Theoretical basis: Reported (Social Ecological model)

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Place, Race, Gender

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low risk 
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasHigh riskUnit of analysis not addressed

Reilly 2006

Methods

Trial design: Cluster randomised controlled trial

Intervention period: 24 weeks

Follow-up period (post-intervention): 6 months

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Reported

Unit of allocation: Nursery

Unit of analysis:  Individual

Participants

N (controls baseline) = 277

N (controls follow-up) = 259 (at 12 months)

N (interventions baseline) = 268

N (interventions follow-up) = 245 (at 12 months)

Setting [and number by trial group]: Nurseries (intervention n = 18; control n = 18)

Recruitment: 36 nurseries were randomly selected from a total of 104 nurseries that were willing to participate (124 nurseries in total were initially invited). All families with children in their preschool year attending the 36 nurseries were eligible to participate.

Geographic Region: Glasgow, Scotland

Percentage of eligible population  enrolled: 47% (from original 124 invited nurseries)

Mean Age:

Intervention: 4.2 ± 0.3 years

Control: 4.1 ± 0.3 years

Sex:

Intervention: 52% female

Control: 48% female

Interventions

Nursery element:

  • Enhanced physical activity programme consisting of three 30 minute sessions of PA each week over 24 weeks.

  • Two members of staff from each intervention nursery attended 3 training sessions to deliver the intervention

  • For 6 weeks during the intervention, each intervention nursery displayed posters focusing on increasing PA through walking and play

  • Capital cost < 200 pounds

Home element:

  • Each participating family received a resource pack of materials (cost = 16 pounds) with guidance on linking physical play at nursery and at home, and two health education leaflets

Control:

  • Usual curriculum and headteachers agreed not to enhance their physical development and movement curriculum

Physical activity interventions versus control

Outcomes

Primary outcome: BMI, expressed as a standard deviation score relative to UK 1990 reference data.

Secondary outcomes: physical activity; sedentary behaviour; fundamental movement skills; process evaluation

Process evaluation: Reported

Implementation related factors

Theoretical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender)

PROGRESS categories analysed at outcome:  Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: No formal evaluation, however costs of materials provided.

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk 
Allocation concealment (selection bias)Low riskAllocation was by nursery and "allocations were concealed by carrying out randomisation of the 36 nurseries at the same time..."
Blinding (performance bias and detection bias)
All outcomes
Low riskResearchers who made the outcome measures were blinded to nursery allocation with the exception of the statistician who carried out the allocation and the contact between the research team and the nurseries. Nurseries were made aware of their allocation status.
Incomplete outcome data (attrition bias)
All outcomes
Low riskParticipant flow provided and similar proportion of missing data from both groups
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasLow riskAnalysis conducted at the individual and nursery level.

Robbins 2006

Methods

Trial design: Cluster randomised controlled trial

Intervention period: 12 weeks

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Not Reported

Reliable outcomes: Reported

Protection against contamination: Not Reported

Unit of allocation: Grade

Unit of analysis:  Individual

Participants

N (controls baseline) = 32

N (controls follow-up) = 32

N (interventions baseline) = 45

N (interventions follow-up) = 45

Setting: School (n=2, Intervention: 3 grades; Control: 3 grades)

Recruitment: Girls who were inactive most days of the week and had no health condition limiting physical activity in grades 6, 7 and 8 from two middle schools in low socio-economic areas in the Midwest

Geographic Region: United States of America

Percentage of eligible population  enrolled: 100% of eligible

Mean Age:

Intervention Grade 6: 11.45 (0.80), Grade 7: 12.37 (0.50), Grade 8: 13.00 (0.00)

Control Grade 6: 11.25 (0.46), Grade 7: 12.27 (0.59), Grade 8: 13.44 (0.53)

Sex: Girls only

Interventions
  • To encourage physical activity each girl in the intervention group received computerized, individually tailored feedback messages based on their responses to the baseline questionnaires

  • Individual counselling (10 minutes) from the school's paediatric nurse practitioner (PNP) to discuss, and negotiate individual physical activity targets to be achieved

  • Telephone calls and mailings to participants and parents

Physical activity interventions versus control

Outcomes

Height, Weight

Physical activity frequency, intensity, duration, and  readiness

Physical activity determinants: interpersonal influences, activity-related affect (physical activity enjoyment), self efficacy, and perceived benefits and barriers of physical activity

Process evaluation: Reported

Implementation related factors

Theoretical basis: Health Promotion Model and Transtheoretical Model

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Not Reported

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Computer assignment to either an intervention or control group was based upon a numerical code that included school group and grade. Flip-of-a-coin randomisation identified the grade and school assigned to each condition"
Allocation concealment (selection bias)Low riskRandomisation was at school level and was performed on all units at the start of the study
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low risk 
Selective reporting (reporting bias)High risk 
Other biasHigh riskUnit of analysis issues not addressed

Robinson 2003

Methods

Trial Design: Randomised controlled trial
Intervention period: Twelve weeks
Follow-up (post-intervention): Nil
Differences in baseline characteristics: Reported.
Reliable outcomes: Reported
Protection against contamination: Not reported
Unit of allocation: Child
Unit of analysis: Child

All analyses were performed according to intention to treat principles

Participants

N (controls- baseline) = 33
N (controls- follow-up) = 33
N (interventions- baseline) = 28
N (interventions-follow-up) = 26

Recruitment: all consenting 8-10 year old, African American girls with BMI >=50th percentile for age and gender, and a parent with a BMI = 25. Set in Oakland and Palo Alto, California, US.

Proportion of eligibles participating: Not stated, but criteria kept broad. Intended to recruit 50 and 61 were enrolled.

Mean Age: Intervention: 9.5 (SD 0.8) years; Controls: 9.5 (SD 0.9)
Sex: girls only.

Interventions

After school dance classes set in community centers designed to improve physical activity, reduce sedentary behaviours and enhance diet. The intervention called START (sisters taking action to reduce television) was delivered by trained university based dance instructors and a female African American intervention specialist. The programme consisted daily dance classes during school weeks and reducing television was covered in five home based lessons. Four community lectures were also provided.
Controls received newsletters and health education lectures

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes
  • Body Mass Index

  • Waist circumference

  • Physical maturation

  • Dual X-Ray Absorptiometry (DEXA) for % Body fat

  • Physical activity:

    • CSA accelerometer,

    • a modification of the Self-Administered Physical Activity Checklist (SAPAC),

    • GEMS Activity Questionnaire(GAQ) computerised

  • Dietary intake measured by two 24 hour recalls using Nutrition Data System computer programme (NDS-R)

Process evaluation: Reported

Implementation related factors

Theoretical basis: Social cognitive theory

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Education, SES)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"...urn randomization procedure was used to generate the treatment allocation sequences. The different sequences were stored on a computer at the CC, and accessed using an interactive voice-response telephone system." (Rochon 2003)
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Low riskOutcome assessors were blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskMissing data minimal and reasons given
Selective reporting (reporting bias)High riskDid not report % body fat at endpoint despite noting this as a measure and recording at baseline
Other biasLow risk 

Rodearmel 2006

Methods

Trial design: Cluster randomised controlled trial

Intervention period: 13 weeks

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Reported

Unit of allocation: Family

Unit of analysis:  Individual

Participants

N (controls baseline):

Families n=23

Target girls n = 14; Target boys n = 11

Other girls n = 9; Other boys n = 10

N (controls follow-up): Families n = 19; Target girls n = 12; Target boys n = 8; Other girls n = 6; Other boys n = 6

N (interventions baseline): Families n = 82; Target girls n = 40; Target boys n = 53; Other girls n = 30; Other boys n = 22

N (interventions follow-up): Families n = 62; Target girls n = 29; Target boys n = 39; Other girls n = 16; Other boys n = 18

Setting [and number by trial group]: Families (intervention n = 82; control n = 23)

Recruitment: Families from Fort Collins, CO area with at least one 8- to 12-year old child who was at-risk-for-overweight or overweight (?85th percentile BMI-for-age) (target child) who would participate with at least one parent or guardian were recruited. Recruitment by printed flyers and email advertising.

Geographic Region: Fort Collins, Colorado, USA

Percentage of eligible population  enrolled: Not Reported

Mean Age:

Intervention:

  • Target girls 10.1±0.2

  • Target boys 9.8±0.2

  • Other girls 12.8±0.7

  • Other boys 11.8±0.4

Control:

  • Target girls 9.9±0.4

  • Target boys 9.9±0.2

  • Other girls 11.8±0.8

  • Other boys 12.0±0.7

Sex: Intervention 55% female; Control 56% female

Interventions

Intervention group:

  • Families asked to maintain their usual eating and step patterns for the first week of the study to establish baseline, then asked to make two small lifestyle changes consisting of:

    • increasing their daily walking by 2000 steps/day above baseline levels and

    • consuming 2 servings/day of ready-to-eat cereal, one at breakfast and one for a snack.

    • Provided with a step counter and a group-specific step and cereal log and free cereal

Control group:

  • Asked to maintain their usual eating and step patterns throughout the study.

  • Provided with a step counter and a group-specific step and cereal log

Both groups:

  • All family members asked to record their daily steps and cereal servings consumed

  • Attended three group meetings throughout study period for measurement and data collection

  • Given magnets and stickers with written reminders to record daily data. Also provided with calculators

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes
  • Steps

  • Cereal servings consumed

  • Food intake

  • Body weight/adiposity

  • For adults:

    • Body weight

    • BMI

    • % body fat

  • For children:

    • % BMI-for-age

    • % body fat

Process evaluation: Reported

Implementation related factors

Theoretical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender)

PROGRESS categories analysed at outcome:  Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskHigher proportion of drop outs in intervention group. Not clear how this may have affected results.
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasHigh risk

This study chose to enrol more families into the intervention group then control, so as a result the numbers of participants in the control group are very small, limiting the power for comparison.

Not known if unit of analysis issues were addressed

Sahota 2001

MethodsTrial Design: Cluster randomised controlled trial
Intervention period: one year
Follow-up (Post-intervention): Nil
Differences in baseline characteristics: Reported.
Reliable outcomes: Reported
Protection against contamination: Not done. (schools which were controls one year received the intervention the following year).
Unit of allocation: School
Unit of analysis: Child.
Unit of analysis errors addressed.
Participants

For weight and height:
N (controls baseline) = 312
N (controls follow-up) = 303
N (intervention baseline) = 301
N (intervention follow-up) = 292
N of schools: 10
Recruitment: Not clear
Geographical setting: Northern UK.
Proportion of eligibles participating: For weight and height: control 97%, intervention 96%

Mean Age:
Control: 8.42 (0.63) years
Intervention: 8.36 (0.63) years
Sex: both sexes included
Control: 59% boys Intervention: 51% boys.

Interventions

School-based intervention - Active Programme Promoting Lifestyle in Schools (APPLES). The programme was designed to influence diet and physical activity and not simply knowledge. Targeted at the whole school community including parents, teachers and catering staff. The programme consisted of teacher training, modifications of school meals and the development and implementation of school action plans designed to promote healthy eating and physical activity.
Control schools received usual curriculum

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes

Body Mass Index
Dietary intake - 24 hour recall and 3 day food diaries
Physical activity - frequency of physical activity and sedentary behaviour was measured by questionnaire.
Psychological measures - three validated measures including a Self-Perception Profile for Children, a questionnaire to distinguish global self-worth from competence and a measure of dietary restraint

Process evaluation: Reported

Implementation related factors

Theoretical basis: multicomponent health promotion programme, based on the Health Promoting Schools concept

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race, Gender)

PROGRESS categories analysed at outcome: Not Reported

Outcomes relating to harms/unintended effects: Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"We randomised them to receive the intervention or to serve as the comparison school using the toss of a coin."
Allocation concealment (selection bias)Low riskSchools were recruited, then all were randomised at the same time at the start of the study and interventions were implemented throughout participating schools.
Blinding (performance bias and detection bias)
All outcomes
High riskOutcome assessment was not blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskParticipant flow provided and completion rate by outcome measure given
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasLow riskUnit of analysis issues addressed

Sallis 1993

Methods

Trial Design: Cluster randomised controlled trial

Intervention period: Two years

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported
Protection against contamination: Unclear
Unit of allocation: School
Unit of analysis: Child.
Not known if unit of analysis errors addressed.

Participants

N (controls and intervention not reported separately ) = 740
N (follow-up) = 549 (data presented for these.) From graphs: Controls = 198; teacher intervention = 200 and specialist intervention = 98.
N of schools: 6 (one school added to control group, 7 schools in total)

Setting: School
Geographic Region: California, US.

Age range (mean) 9.25 years
Sex: both sexes included; 55.5% boys.

Interventions

School-based intervention. Followed the (Sports, Play and Active Recreation for Kids) SPARK intervention, incorporating physical education and self-management into the school curriculum. Two intervention schools, led by either 1) certified physical education specialists or 2) classroom teachers evaluated against a control.
Controls received usual PE curriculum.

Physical activity interventions versus control

Outcomes

Weight Status: BMI presented at fall 1990, spring 1991, fall 1991 and spring 1992

Process evaluation: Not Reported

Implementation related factors

Theoretical basis: Behaviour change and self-management

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race, Gender)

PROGRESS categories analysed at outcome: Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk12 schools were "randomly assigned" to the 3 experimental conditions, however an additional school was recruited and added to the control group after this process was conducted.
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
High riskMissing data (26%) not provided by study group and reasons for attrition not given
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasHigh riskUnit of analysis issues not addressed.

Salmon 2008

Methods

Trial design: Cluster randomised controlled trial

Intervention period: 6 months

Follow-up period (post-intervention): 1 year (assessments at 6, 12 months post-intervention)

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Reported

Unit of allocation: Class

Unit of analysis:  Individual

Participants

N (controls baseline) = 62

N (controls 12 month follow-up) = 55

N (behavioural modification (BM) intervention baseline) = 66

N (BM 12 month follow-up) = 60

N (fundamental motor skills (FMS) intervention baseline) = 74

N (FMS 12 month follow-up) = 69

N (BM/FMS baseline) = 93

N (BM/FMS 12 month follow-up) = 84

Setting [and number by trial group]: 17 classes across 3 schools. Number of classes in each trial group not reported.

Recruitment: All Grade 5 students within 3 selected government schools located across 4 campuses in low SES areas

Geographic Region: Melbourne, Australia

Percentage of eligible population  enrolled: 78%

Mean Age:

Male 10 years 8 months ± 5 months

Female 10 years 8 months ± 4 months

Sex: 51% female

Interventions

Three intervention groups:

  • Behaviour Modification (BM) group: In addition to the usual physical education and sports classes, 19 lessons (40-50 min each) were delivered in classroom by one qualified physical education teacher for 1 school year. Lessons incorporated self-monitoring time spent in physical activity and screen behaviours, health benefits of physical activity, sedentary behaviour environments, decision-making and identifying alternatives to screen behaviours, intelligent TV viewing and reducing viewing time, advocacy of reduced screen time, use of pedometers and group games.

  • Fundamental Motor Skills (FMS) group: In addition to the usual physical education and sports classes, 19 lessons (40-50 min each) were delivered either in the indoor or outdoor physical activity facilities at each school for 1 school year. Lessons focused on mastery of six fundamental movement skills (run, throw, dodge, strike, vertical jump, and kick). The interventionist taught the skills with an emphasis on enjoyment and fun through games and maximum involvement for all the children.

  • BM/FMS group: children in this group received both BM and FMS lessons.

Physical activity interventions versus control

Outcomes
  • BMI

  • Overweight/Obesity

  • Objectively assessed physical activity (accelerometer) - physical activity measured for 8 days during waking hours, except when bathing or swimming

  • Self-reported screen behaviours

  • Self-reported enjoyment of physical activity (five-point Likert scale)

  • Mastery of fundamental movement skills

  • Body Image (five-point Likert scale) - rate their satisfaction with their body weight and body shape

  • Food intake: Children were asked to complete a 22 item food-frequency questionnaire to determine the energy density of their diet

Process evaluation: Reported

Implementation related factors

Theoretical basis: Social cognitive theory and behavioural choice theory

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Place, Gender, Education, SES)

PROGRESS categories analysed at outcome: Reported (Gender)

Outcomes relating to harms/unintended effects: Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomised by withdrawing a ticket from a container
Allocation concealment (selection bias)Low riskAllocation was by class and all classes were randomised at the start of the study
Blinding (performance bias and detection bias)
All outcomes
Low riskThe five specialist evaluators who examined video tapes of children performing the fundamental movement skills to assess the children's mastery of these skills were blind to the group assignment.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskCannot be determined
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasLow riskAdjusting for clustering by class

Sanigorski 2008

Methods

Trial design: Cohort Analytic

Intervention period: 3 years

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Reported

Unit of allocation: School

Unit of analysis:  School

Participants

N (controls baseline) = 1183

N (controls follow-up) = 974

N (interventions baseline) = 1001

N (interventions follow-up) = 833

Setting [and number by trial group]: preschools and primary schools (n=10 intervention)

Recruitment: All preschools (n = 4, age 4 years) and primary schools (n = 6, age 5-12 years) in Colac with ?20 enrolled children were included in sample frame. Comparison group sampled from a regionally representative population.

Geographic Region: Colac, Australia

Percentage of eligible population  enrolled: 49.5%

Mean Age:

Intervention 8.21 (2.26) years

Control 8.34 (2.22) years

Sex:

Intervention 54% female

Control 50% female

Interventions
  • Nutrition strategies

    • School-appointed dietitian for support

    • School nutrition policies

    • Training for canteen staff

    • Canteen menu changes

    • Lunch pack

    • Professional development for teachers about healthy eating curriculum

    • One-off class sessions conducted by dietitians

    • Fresh taste programme (Melbourne Markets) and Healthy breakfast days

    • Interactive, children's newsletters/teacher fliers

  • Promotional materials

    • Happy healthy families programme (small groups, 6 weeks)

    • Parent tips sheets (set of 10)

    • Healthy lunchbox tip sheets

  • Community garden

    • Choice chips programme (7 hot chip outlets in Colac)

    • Fruit shop displays (3 shops involved)

  • Physical activity strategies

    • After-school activities programme

    • Be Active Arts programme

    • Walking school buses

    • Walk to school days

  • Promotional materials

    • Sporting club coach training

    • Sporting club equipment

    • Pedometers

  • Screen time

    • TV power-down week, including a 2-week curriculum

    • Interactive, children's newsletters / Teacher fliers

  • Across all strategies

    • Sponsorship of the Colac Kana festival 2004

    • Sponsorship of kids day out 2003

    • Broad media coverage over 4 years (57 newspaper articles, 21 paid adverts)

    • Incorporation of BAEW strategies on Municipal Early Years Plan Colac Otway Shire

    • Incorporation of BAEW strategies into Integrated Health Promotion Plan (Colac Area Health) and Municipal Public Health Plan (Colac Otway Shire)

    • Social marketing training; Obesity-prevention training

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes
  • Body weight (kg)

  • Waist circumference (cm)

  • BMI (kg/m2)

  • Waist/height

  • BMI-z score

  • Prevalence/incidence of overweight/obesity

  • Relationship between baseline indicators of children's household SES and changes in children's anthropometry

Process evaluation: Reported (www.goforyourlife.vic.gov.au/hav/articles.nsf/pracpages/Be_Active_Eat_Well)

Implementation related factors

Theoretical basis: Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender, SES)

PROGRESS categories analysed at outcome:  Reported (Education, SES)

Outcomes relating to harms/unintended effects: Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskNot randomised
Allocation concealment (selection bias)High riskNot randomised
Blinding (performance bias and detection bias)
All outcomes
Low riskBlinding not feasible, however primary outcomes were objective and not likely to be affected
Incomplete outcome data (attrition bias)
All outcomes
Low risk 
Selective reporting (reporting bias)Low risk 
Other biasLow riskNo unit of analysis issues

Sichieri 2009

Methods

Trial design: Cluster randomised controlled trial

Intervention period: 7 months of 1 school year

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Reported

Unit of allocation: School

Unit of analysis: Individual with clustering by class

All analyses were performed according to intention to treat principles

Participants

N (controls baseline) = 608

N (controls follow-up) = 493

N (interventions baseline) = 526

N (interventions follow-up) = 434

Setting [and number by trial group]: 47 classes (n = 23 intervention; n = 24 control) in 22 schools

Recruitment: All fourth graders from 22 public schools in metropolitan city of Niteroi were invited to participate.

Geographic Region: Niteroi, Rio de Janeiro, Brazil

Percentage of eligible population  enrolled: 98%

Mean Age: (intervention + control)

Intervention: 10.9 ± 0.81

Control: 10.9 ± 0.75

Sex: Intervention: 53.1% female; Control: 52.6% female

Interventions

Focus on the reduction in consumption of sugar-sweetened carbonated beverages by students:

  • Healthy lifestyle education programme, social marketing

  • Simple messages encouraging water instead of SSB

  • Formative and developmental work performed prior

  • Classroom quizzes, games, activities to promote water over SSB

  • Children make drawings and songs

  • 10x 1 hr sessions of activities facilitated by 4 trained researchers who were assigned for each class

  • Activities required 20-30 min and teachers encouraged to reinforce the messages during their lessons

  • Printed materials provided to RAs and music teachers to facilitate sessions

Dietary interventions versus control

Outcomes

Outcome measures:

  • Primary outcome: change in BMI, carbonated SSB and juice intake

  • Secondary outcomes: overweight and obesity

Process evaluation: Not reported

Implementation related factors

Theoretical basis: Not reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender, Race)

PROGRESS categories analysed at outcome:  Reported (Gender)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Low riskRandomisation at school level and all schools randomised at start of study
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low risk 
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasLow riskITT analysis performed taking into account clustering by class

Simon 2008

Methods

Trial design: Cluster randomised controlled trial

Intervention period: 4 years

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Reported

Unit of allocation: School

Unit of analysis:  School, Individual

Sensitvity analysis conducted using intention to treat population to compare this with analysis using data from only those participants who completed the study.

Participants

N (controls baseline) = 479 (blood samples n=326)

N (controls follow-up) = 358

N (interventions baseline) = 475 (blood samples n=304)

N (interventions follow-up) = 374

Setting [and number by trial group]: 8 schools (4 in each group)

Recruitment: Four pairs of matched schools randomly selected out of 77 public middle schools of the Department of Bas-Rhin. All six-graders in randomised schools were eligible.

Geographic Region: Eastern France

Percentage of eligible population  enrolled: 91% (surveys); 73% (blood samples)

Mean Age:

Intervention: 11.7 ± 0.7

Control: 11.6 ± 0.6

Sex:

Intervention: 52.6% female

Control: 47.4% female

Interventions

programme began during first school year and ran until end of fourth school year

  • Educational component focusing on physical activity and sedentary behaviours

  • New opportunities for PA offered in lunchtime, breaks and after school hours taking account of barriers to PA

  • Activities organised by formal physical educators, no competitive aspect

  • Enjoyment highlighted to help less confident children

  • Sporting events and cycling to school days

  • Parents and educators encouraged to support PA through regular meetings

[Physical activity interventions versus control]

Outcomes

Primary Outcome:  BMI

Secondary Outcomes:

  • Self-reported leisure physical activity ? assessed with the Modifiable Activity Questionnaire for adolescents. 

  • Time spent in front of TV/video and in active commuting between home and school

  • Self-efficacy and intention toward physical activity (lower scores indicating better outcomes) were assessed with the Stanford Adolescent Heart Health Programmes questionnaire

  • Cardiovascular risk factors

Process evaluation: Reported

Implementation related factors

Theoretical basis: Behaviour change and socio-ecological model

Resources for intervention implementation (e.g. funding needed or staff hours required): Not Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender,, SES)

PROGRESS categories analysed at outcome:  Reported (Gender,, SES)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

NotesStudy rationale, research design, intervention programme and process evaluation described in additional papers (Simon et al. Int J Obes Relat Metab Disord 2004; 28 (Suppl 3):S96-S103; Simon et al. Diabetes Metab 2006;32:41-49)
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Low riskRandomised at the school level and all schools randomised at start of study
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low risk 
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasLow riskAnalysis at school and individual level

Singh 2009

Methods

Trial design: Cluster randomised controlled trial

Intervention period: 8 months

Follow-up period (post-intervention): 4 months and 12 months post-intervention (12 and 20 month observations respectively)

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Reported

Unit of allocation: School

Unit of analysis:  Individual with multilevel analysis that included student, class, school

All analyses were performed according to intention to treat principles

Participants

N (controls baseline) = 476

N (controls follow-up) = Not reported by group

N (interventions baseline) = 632

N (interventions follow-up) = Not reported by group

Setting [and number by trial group]: schools (n = 10 intervention; n = 8 control). Three classes in each school were included.

Recruitment: Participating schools were asked to select 3 classes of first-year students. Selection of classes was based on practical reasons.

Geographic Region: The Netherlands

Percentage of eligible population  enrolled: 84%

Mean Age:

Intervention: Boys = 12.8±0.5; Girls = 12.6 ± 0.5

Control: Boys = 12.9±0.5; Girls = 12.7 ± 0.5

Sex:

Intervention: 53% female

Control: 47% female

Interventions

Aim was to increase awareness and induce behavioural changes:

  • Reduction in consumption of sugar-sweetened beverages

  • Reduction in consumption of high-sugar, high-fat-content snacks

  • Reduction in sedentary behaviour

  • Increase in active transport behaviour

  • Maintenance of level of sports participation

  • Individual component:

    • educational programme covering 11 biology and physical education lessons.

  • Environmental component:

    • School-specific advice on selection of school canteen and possible change options

    • Financial encouragement of schools to offer additional physical activity options

  • Utilised the Intervention Mapping Protocol which facilitates a systematic process of designing health promotion interventions and based on theory and empirical evidence

  • Behaviour change methods used:

    • Self-monitoring, self-evaluation

    • Reward

    • Increasing skills

    • Goal setting

    • Environmental changes

    • Social encouragement

    • Social support

    • Information regarding behaviour

    • Personalised messages

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes

Outcome measures

  • Primary Outcome:

    • Changes in body composition (i.e. waist circumference, skinfold thickness and BMI)

  • Secondary Outcomes:

    • Changes in dietary and physical activity behaviour (EBRBs)

    • Consumption of sugar-containing beverages (i.e. consumption of soft drinks and fruit juices)

    • Consumption of high-energy snacks (i.e., consumption of savoury snacks and sweet snacks)

    • Screen-viewing behaviour (i.e., time spent on television viewing and computer use)

    • Active commuting to school

Process evaluation: Reported

Implementation related factors

Theoretical basis: Reported (Intervention mapping protocol, behaviour change and environmental frameworks)

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender, Race)

PROGRESS categories analysed at outcome:  Reported (Gender, Race)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes

Protocol published separately. Refer to: Singh et al. BMC Public Health 2006, 6:304 doi:10.1186/1471-2458-6-304

This also includes 8-month outcome data published in Singh et al. Arch Pediatr Adolesc Med 2007;161:565-571

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk 
Allocation concealment (selection bias)Low riskRandomisation occurred at the school level and was performed on all units at the start of the study
Blinding (performance bias and detection bias)
All outcomes
High riskResearch assistants involved in conducting measurements and delivering intervention materials were not blinded. Other members of the research team who helped with the measurements were blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low risk 
Selective reporting (reporting bias)Low riskStudy protocol published
Other biasLow riskMultilevel analysis included student, class, school

Spiegel 2006

Methods

Trial design: Cluster randomised controlled trial

Intervention period: 5-6 months

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Not Reported

Reliable outcomes: Reported

Protection against contamination: Reported

Unit of allocation: Classroom

Unit of analysis:  Individual (not adjusted for clustering by classroom)

Participants

N (controls baseline) = 572

N (controls follow-up) = 479

N (interventions baseline) = 619

N (interventions follow-up) = 534

Setting: Classrooms in Schools

Recruitment: Fourth and fifth graders from 16 schools (69 classes) in four states (Delaware, Florida, Kansas, and North Carolina)

Geographic Region: United States of America

Percentage of eligible population  enrolled: Not Reported

Mean Age: Not Reported (fourth and fifth graders)

Sex: Both males and females

Interventions
  • The WAY intervention programme was teacher led

  • Intervention teachers participated in workshops & received programme materials. 

  • The programme was integrated throughout the school year with activities ranging in engagement time from 20 minutes to more extensive activities that require 1 hour or more

  • Students were engaged in multidisciplinary activities in language arts, mathematics, science, and health content, building their academic skills while developing their health attitudes, behavioural intent, and, ultimately, behaviour

  • Used directed-reflective journaling and class discussions with students that were reinforced over time

  • Students were provided with an orientation to the programme and activities through video and print resources

  • Intervention classes followed a 10-minute aerobic exercise routine each day during class time. The video provided a common baseline exercise routine for all intervention classes

  • The programme activities were organized into seven discrete modules.

    • Module 1 orients students to the programme and the concept of wellness and has them record a baseline description of their understanding, interpretations, and attitudes of themselves and wellness.

    • Module 2 is where the students learn how to collect, report, and analyze data about themselves and their health and reflect on their attitudes and beliefs related to the data

    • and their health behaviorus.

    • Module 3 focuses on physical activity and fitness. Students learn about the F.I.T.T. (Frequency, Intensity, Time, and Technique) principles, how to design a basic workout

    • routine, and how to incorporate physical activity into their daily routine

    • Module 4 addresses nutrition and diet

    • Module 5 is where students learn more about their bodies (how they move, the parts and systems of their bodies); how their behaviours influence their bodies; how researchers learn about their bodies (medical technology and research); how to be a good consumer of health information; and basic information and attitudes about disease transmission.

    • Module 6 provides an orientation to genetics and family health history as a resource to examining personal health.

    • Module 7 is where students practice the information and skills they learned in class. They conclude the year with a review of their personal goals and a personal assessment of their progress toward the goal

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes

Height, Weight

Diet (survey)

Physical activity levels (survey)

Process evaluation: Reported

Implementation related factors

Theoretical basis: Reported (Theory of Reasoned Action, Constructivism)

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Place, SES)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low risk 
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasHigh riskAnalysis not adjusted for clustering by classroom

Stolley 1997

Methods

Trial Design: Randomised controlled trial
Intervention period: 12 weeks

Follow-up (post-intervention): Nil
Differences in baseline characteristics: Reported.
Reliable outcomes: Reported

Protection against contamination: Not possible
Unit of allocation: Child
Unit of analysis: Child.

Participants

N (intervention baseline) = 32mothers and 32 daughters
N (control baseline) = 30 mothers and 33 daughters
N (intervention follow-up) = 20 mothers and 23 daughters have dietary data reported however, stated that in all 51 mothers (78%) and 54 daughters (83%) had data collected.

Unable to separate intervention from control figures with data provided.
Geographical setting: Chicago, US.

Age: 7 to 12 years, mean age Intervention 9.9 (SD I.3); Controls 10.0 (SD 1.5) years
Sex: girls only.

Interventions

Set up within a community based tutoring programme this intervention examined the effectiveness of a culturally specific obesity prevention programme for low-income, inner-city African American, preadolescent girls and their mothers.
Programme focused on adopting a low-fat, low-calorie diet and increased activity.
Controls were offered a general health programme.

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes

Mother and daughters:

Body weight and height

% overweight

Daily caloric intake, total fat gram intake, % calories from fat, sat fat, dietary cholesterol assessed by Quick Check for Fat (QCF) and analysed with Quick Check Diet (QCD).

Parental completion of a self-report measure of parental support and role modelling around food.

Process evaluation: Reported

Implementation related factors

Theoretical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required):Not Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Occupation, Gnder, Education, SES)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
High risk78% of mothers completed the study with a difference in weight between completers and dropouts. Thinner mothers were more likely to drop out (p<0.05).
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasLow risk 

Story 2003a

MethodsTrial Design: Randomised controlled trial
Follow-up: Twelve weeks.
Differences in baseline characteristics: Reported.
Reliable outcomes: Reported
Protection against contamination: Not reported.
Unit of allocation: Child
Unit of analysis: Child.
Participants

N (controls baseline) = 27
N (controls follow-up) = 27
N (intervention baseline) = 26
N (intervention follow-up) = 26

Proportion of eligibles participating: Not stated, but criteria kept broad. Intended to recruit 50 and 61 were enrolled

Geographical setting: Minnesota, US.

Mean Age: Intervention 9.4 (SD 0.9); Controls 9.1 (SD 0.8) years
Sex: girls only.

Interventions
  • After school classes set in schools designed to improve skill building and practice in support of health behaviour messages in the programme.

  • Included drinking water, eating more fruit, vegetables and low fat foods, increasing physical activity reducing TV watching and enhancing self-esteem.

  • The intervention was delivered by African American GEMS staff. Family contact and activities supported the intervention.

  • Controls received a 12 week programme unrelated to nutrition and physical activity (enhancing self-esteem and cultural enrichment).

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes
  • Body Mass Index

  • Waist circumference

  • Physical maturation

  • Dual X-Ray Absorptiometry (DEXA) for % Body fat

  • Physical activity: CSA accelerometer, a modification of the Self-Administered Physical Activity Checklist (SAPAC), GEMS Activity Questionnaire(GAQ) computerised

  • Dietary intake measured by two 24 hour recalls using Nutrition Data System computer programme (NDS-R).

  • Psychological variables:

    • Body silhouettes McKnight Risk Factor Survey, and Stunkard et al. 1983.

    • Healthy choice Behavioural Intentions (diet)

    • Self-Efficacy for Healthy Eating

    • Physical Activity Outcomes Expectations, and a self-efficacy measure.

Process evaluation: Reported

Implementation related factors

Theoretical basis: Social cognitive theory, youth development, and resiliency based approach

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race, Education, SES)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"...urn randomization procedure was used to generate the treatment allocation sequences. The different sequences were stored on a computer at the CC, and accessed using an interactive voice-response telephone system." (Rochon 2003)
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low riskMissing data minimal (1 participant).
Selective reporting (reporting bias)High riskDid not report % body fat at endpoint despite noting this as a measure and recording at baseline
Other biasLow risk 

Taylor 2008

Methods

Trial design: Controlled clinical trial

Intervention period: 2 years

Follow-up period (post-intervention): two years

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Not Reported

Unit of allocation: Community

Unit of analysis: Individual

Participants

N (controls baseline) = 270

N (controls post-intervention) = 207

N (controls follow-up) = 274

N (interventions baseline) = 302

N (intervention post-intervention) = 177

N (intervention follow-up) = 280

Setting: Primary schools (4 intervention, 3 control)

Recruitment: Children aged 5-12 years from 7 primary schools from 2 geographic regions

Geographic Region: New Zealand

Percentage of eligible population  enrolled: Intervention: 92%, Control: 87%

Mean Age: Intervention:  8.0 (1.7) years; Control: 7.9 (1.5) years

Sex: Both males and females

Interventions
  • A community activity co-ordinator was employed at each school in the intervention area for 20 hours per week to increase non-curricular activity at recess, lunchtime, and after school. (provided 8 hours of activity programming in the school)

  • Specific activities varied by school but resources facilitating short bursts of activity in class were developed and sports equipment were made available to encourage free play

  • In the second year of the project, intervention initiatives were nutrition-based, and included provision of cooled water filters in each school, science lessons highlighting the adverse health effects of sugary drinks, a community-based healthy eating resource, an interactive card game, and the provision of free fruit for 6 months

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes
  • Height, weight, waist circumference

  • Blood pressure heart rate

  • Physical activity (accelerometer and 7-day recall)

  • Television viewing time (recall)

Process evaluation: Not reported

Implementation related factors

Theoretical basis: Not reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Place, Race, Gender)

PROGRESS categories analysed at outcome:  Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

NotesTaylor 2006, 2007 & 2008
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskNot Randomised
Allocation concealment (selection bias)Unclear riskNot Randomised
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low riskReasons given for missing data and demographic characteristics of those lost to follow-up were similar to those remaining in the study.
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasUnclear riskCannot be determined

Vizcaino 2008

Methods

Trial design: Cluster randomised controlled trial

Intervention period: 24 weeks (during the 2004-2005 academic year)

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Reported

Unit of allocation: School

Unit of analysis:  Individual

All analyses were performed according to intention to treat principles

Participants

N (controls baseline) = 606

N (controls follow-up) = 579

N (interventions baseline) = 513

N (interventions follow-up) = 465

Setting [and number by trial group]: Schools (n = 10 intervention; n = 10 control)

Recruitment: Selected 20 schools in 20 towns in the Province of Cuenca, Spain. Fourth and fifth-grade children in participating schools were invited to participate.

Geographic Region: Cuenca, Spain

Percentage of eligible population  enrolled: 79%

Mean Age:

Intervention: boys = 9.4 ± 0.7 years; girls = 9.4 ± 0.7 years

Control: boys = 9.5 ± 0.7 years; girls = 9.4 ± 0.6 years

Sex:

Intervention : 48.9% female

Control: 49.6% female

Interventions
  • Implemented during the 2004/2005 academic year, consisted of 3 x 90-min sessions per week for 24 weeks. These were held after school.

  • 90-min session included 15 min of stretching, 60 min of aerobic resistance and 15 min of muscular strength/resistance exercise

  • Non-competitive recreational physical activity  programme (Movi) adapted to children's age and held at the schools athletic facilities ? usually children went home after class then returned to school for programme.

  • Physical activity sessions planned by two qualified physical education teachers and supervised by sports instructors

  • Sessions included sports with alternative equipment (pogo sticks, Frisbees, jumping balls, parachutes, etc, cooperative games, dance and recreational athletics

  • Sports instructors had 2-day training programme and written plan of activities for each session was developed for standardisation

  • Standard physical education curriculum continued  in both intervention and control schools.

  • Further details at www.movidavida.org

Physical activity intervention versus control

Outcomes
  • BMI

  • Triceps skin-fold thickness

  • Percentage body fat

  • Blood pressure

  • 12 hour fasting blood samples to measure: total cholesterol, triglycerides, apo A and apo B

Process evaluation: Reported

Implementation related factors

Theoretical basis: Not Reported

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender)

PROGRESS categories analysed at outcome:  Reported (Gender)

Outcomes relating to harms/unintended effects: Not reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: No formal evaluation, however average cost per child was provided (28 euros per child per month)

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskused a computer-generated procedure
Allocation concealment (selection bias)Low riskRandomisation occurred at the school level and "Schools were informed of the result of randomisation after they agreed to participate in the study"
Blinding (performance bias and detection bias)
All outcomes
High riskNurses who made the anthropometric and blood pressure measurements were not blinded to intervention allocation. Laboratory analysts who determined blood lipids were blinded to school allocation
Incomplete outcome data (attrition bias)
All outcomes
Low riskLow rates of attrition between groups
Selective reporting (reporting bias)Unclear riskProtocol not available
Other biasLow riskAnalysis conducted taking clustering into account

Warren 2003

Methods

RCT

Intervention period: Fourteen moths

Follow-up (post-intervention): Nil
Differences in baseline characteristics: Reported.
Reliable outcomes: Reported
Protection against contamination: Not reported.
Unit of allocation: Child
Unit of analysis: Child.

Participants

N (controls and interventions - baseline) = 218
N (controls follow-up) = 54
N (3 interventions follow-up) = 164

Recruitment: all consenting 5-7 year-olds from 3 primary schools. Set in central UK.

Proportion of eligibles participating: Not stated

Mean Age: all groups 6.1 (SD 0.6) years;
Sex: both sexes; 51% boys.

Interventions
  • School and family-based interventions focusing on nutrition, physical activity, or both, upon the prevalence of overweight/obesity.

  • The setting was lunchtime clubs where an interactive and age-appropriate nutrition and/or physical activity curriculum was delivered by the project team.

  • Controls received an education programme covering the non-nutritional aspects of food and human biology.

Combined effects of dietary interventions and physical activity interventions versus control

Outcomes
  • Body Mass Index

  • Skinfolds measured at five sites (biceps, triceps, subscapular, supra-iliac, calf).

  • Nutrition knowledge: validated questionnaire .

  • Physical activity: children and parents completed basic questions about habitual activity (not validated).

  • Diet: parents reported on behalf of children a 24h recall and a food frequency questionnaire

Process Evaluation: Reported

Implementation related factors

Theoretical basis: Social learning theory

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Gender, Education)

PROGRESS categories analysed at outcome: Not Reported

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCannot be determined
Allocation concealment (selection bias)Unclear riskCannot be determined
Blinding (performance bias and detection bias)
All outcomes
Unclear riskCannot be determined
Incomplete outcome data (attrition bias)
All outcomes
Low riskSimilar numbers missing from each group. Reasons for withdrawal given and characteristics of withdrawals investigated.
Selective reporting (reporting bias)Unclear riskCannot be determined
Other biasLow risk 

Webber 2008

  1. a

    Glossary
    BMI, Body Mass Index
    CSA accelerometer, COmputer Sciences Applicvations accelerometer
    GEMS, Acronym for Girlsl health Enrichment Multi site Studies
    SD, standard deviation
    TSF, Triceps Skinfold
    WHCU weight/height cubed.

Methods

Trial design: Repeated cross-sectional design (cluster randomisation to determine intervention allocation)

Intervention period: 2 year staff-directed intervention followed by 1 year Programme Champion component

Follow-up period (post-intervention): Nil

Differences in baseline characteristics: Reported

Reliable outcomes: Reported

Protection against contamination: Reported

Unit of allocation: School

Unit of analysis:  Individual with group randomisation and the nesting of students within schools, sites and conditions taken into account

Participants

N* (baseline) = 1721 (intervention + control)

N* (follow-up; primary outcome) = 3504 (intervention + control)

*Note: The larger N at follow-up was possible due to the cross-sectional sampling design and the study team decision to recruit twice as many participants at follow-up compared with baseline

Setting [and number by trial group]: School (intervention n = 18; control n = 18)

Recruitment: Public middle schools in which a majority of students lived in the surrounding community, with enrolment of at least 90 8th-grade girls at least one semester of PE in each grade were eligible to participate. Student and parental consent obtained prior to each measurement period during which cross-sectional, random samples of girls were recruited for measurement.

Geographic Region: Louisiana and South Carolina, USA

Percentage of eligible population sampled at baseline: 79.7%

Mean Age:

Intervention = 11.9 years

Control: boys = 12.0 years

Sex: 100% female

Interventions

Intervention activities targeted to create:

  • environmental and organisational changes supportive of physical activity

  • cues, messages and incentives to be more physically active

Activities included:

  • linking schools and community agencies to develop and promote physical activity programmes for girls delivered both on an off school property

  • health education including 6 lessons in each grade to enhance behavioural skills known to influence PA participation

  • After the 2-year staff-directed intervention, a Programme Champion component was conducted for an additional year to foster sustainability. Programme Champions continued existing intervention activities and developed new programmes were possible.

Control schools received a delayed intervention after all measurements were obtained.

Physical activity intervention vs control

Outcomes
  • Physical activity measured by accelerometry

  • Body composition

Process Evaluation: Reported

Implementation related factors

Theoretical basis:

  • Operant learning theory

  • social cognitive theory

  • organisational theory

  • diffusion of innovation theory

  • socio-ecological framework

Resources for intervention implementation (e.g. funding needed or staff hours required): Reported

Who delivered the intervention: Reported

PROGRESS categories assessed at baseline: Reported (Race)

PROGRESS categories analysed at outcome: Reported (Race)

Outcomes relating to harms/unintended effects: Not Reported

Intervention included strategies to address diversity or disadvantage: Not Reported

Economic evaluation: Not Reported

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod of sequence generation not reported
Allocation concealment (selection bias)Low riskAllocation at the school level and all schools were allocated at the start of the study
Blinding (performance bias and detection bias)
All outcomes
Unclear riskBlinding not reported. Separate intervention and measurement staff were employed, however it is not clear whether measurement staff were blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low riskDue to repeated cross-sectional design, the same participants were not followed throughout the study, however all girls in participating schools received the intervention. This design was used to assess intervention effects in the entire population of girls enrolled in participating schools.
Selective reporting (reporting bias)Unclear riskCould not be determined
Other biasLow risk 

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Al-Nakeeb 2007Longitudinal cohort study-No intervention
Alves 2008Intervention designed for the treatment of childhood obesity
Ara 2006Longitudinal cohort study-No intervention
Arbeit 1992Aim of the trial was to prevent cardiovascular disease
Ask 2006Cluster allocation with fewer than six groups
Berry 2007Parent-targeted intervention designed specifically for the treatment of obesity
Bollela 1999aAim of the trial was to improve nutritional intake
Bollela 1999bAim of the trial was to improve nutritional intake
Borys 2000Aim was to improve dietary habits of families
Burke 1998Aim was to improve physical activity
Cairella 1998Aim was to improve nutritional intake
Carrel 2005Intervention recruited only overweight or obese participants so considered treatment for the purposes of this review
Casazza 2006Intervention was less than 12 weeks
Chomitz 2003Aim was to increase parent awareness of child weight status
Cullen 1996Aim of the trial was to prevent children's behaviour disorders
D'Agostino 1999Aim of the trial was to improve nutritional intake
Daley 2006Intervention designed specifically for the treatment of obesity
Danielzik 2005Intervention was less than 12 weeks
Dixon 2000Aim of the trial was to improve nutritional intake
Donnelly 1996Cluster allocation with fewer than six groups
Economos 2007Cluster allocation with fewer than six groups
Flodmark 1993Intervention designed specifically for the treatment of obesity
Florea 2005Intervention designed specifically for the treatment of obesity
Flores 1995Cluster allocation with fewer than six groups
Fonseca 2007Comparative study-No intervention
Gately 2005Intervention duration less than 12 weeks
Goldfield 2006Intervention duration less than 12 weeks
Goldfield 2007Intervention duration was less than 12 weeks
Gortmaker 1999bStudy did not report to be measuring any of the primary outcomes of the review
Harrell 1998Intervention less than 12 weeks duration
Harrell 1999Intervention less than 12 weeks duration
He 2004Intervention designed specifically for the treatment of obesity
Hopper 1996Aim of the trial was to prevent cardiovascular disease
Horodynski 2004Aim of the trial was to improve nutritional intake
Howard 1996Aim of the trial was to prevent cardiovascular disease
Ildiko 2007Intervention designed specifically for the treatment of obesity
Jago 2006Intervention duration less than 12 weeks
Jiang 2006Cluster allocation with fewer than six groups
Jurg 2006Study did not report to be measuring any of the primary outcomes of the review
Koblinsky 1992Aim of the trial was to improve nutritional intake
Lagstrom 1997Aim of the trial was to improve nutritional intake
Lionis 1991Aim of the trial was to assess the effects of a health education intervention aimed at reducing risk for CVD and cancer
Luepker 1996Aim of the trial was to prevent cardiovascular disease
Lytle 2006Aim of the trial was to improve nutritional intake.
Manios 1998Aim of the trial was to improve physical activity and fitness
Manios 1999Aim of the trial was to improve nutritional intake
McCallum 2007Intervention designed specifically for the treatment of obesity
McGarvey 2004Intervention duration less than 12 weeks
McMurray 2002Intervention less than 12 weeks duration
Melnyk 2007Intervention was less than 12 weeks
Niinikoski 1997Aim was to improve nutritional intake
Obarzanek 1997Aim of the trial was to improve nutritional intake
Oehrig 2001Aim of trial was to improve cardiovascular risk factors
Rask-Nissila 2000Aim of trial was to examine neurological development
Reinehr 2007Intervention designed specifically for the treatment of obesity
Resnicow 2005Intervention designed specifically for the treatment of obesity
Robinson 1999Cluster allocation with fewer than six groups
Sadowsky 1999Intervention duration less than 12 weeks
Simonetti 1986This trial was conducted before 1990 and so had been excluded from this review
Spark 1998Aim of the trial was to improve nutritional intake
Stenevi-Lundgren 2009Aim of the trial was to improve bone health outcomes
Stephens 1998Aim of the trial was to improve fitness levels.
Stewart 1995Aim was to improve nutritional intake
Stock 2007Cluster allocation with fewer than six groups
Talvia 2004Aim of trial was to improve nutritional intake.
Tamir 1990Aim of the trial was to prevent cardiovascular disease
Taylor 2005Intervention duration less than 12 weeks
Tershakovec 1998Trial conducted in hypercholesterolaemic children
Treuth 2007Cross-sectional study design. Not evaluating the intervention
Trudeau 2000This was not an intervention study
Vandongen 1995Aim of the trial was to prevent cardiovascular disease
Williams 1998Aim of the trial was to prevent cardiovascular disease
Williamson 2006Intervention recruited only overweight or obese participants so considered treatment for the purposes of this review
Williamson 2007Cluster allocation with fewer than 6 groups

Characteristics of ongoing studies [ordered by study ID]

Adab 2008

Trial name or titleBirmingham Healthy Eating and Active Lifestyle for Children Study (BEACHES)
Methods 
ParticipantsSchool children aged 6 to 8 years particularly focusing on South Asians
InterventionsIntervention still in development phase. Baseline data is being analysed along with reviewing evidence base and receiving expert input. Baseline data consisted of focus groups undertaken with a range of stakeholders to gauge views of childhood obesity and potential prevention interventions explored. Baseline measurements were also taken from participants including: height, weight, waist circumference, skinfolds, BIA, Blood Pressure, Physical Activity assessment, Dietary Assessment, HRQoL, Self concept, Body Image, Demographics (each involved follow-up measures).
Outcomes 
Starting dateTBC
Contact informationAdab Peymane, University of Birmingham
Notes

Communication with the lead author (Adab) has confirmed that no outcomes from this study have been published yet.

ISRCTN51016370

Adams 2009

Trial name or titleTooty Fruity Vegie in Preschools (TFV)
MethodsControlled before and after study evaluating a one-year intervention conducted during 2006-2007 in 18 preschools (matched with 13 control preschools).
ParticipantsRecruited from preschools in NSW, Australia. Those in towns with a high proportion of disadvantaged populations were prioritised.
InterventionsIntervention strategies included skills development and awareness-raising for parents, staff and children, and social support for parents to foster behaviour changes in their children through feedback and reinforcement. Included healthy eating and physical activity strategies.
OutcomesPrimary outcome measures were BMI and waist circumference. Intermediary impact indicators include FMS proficiency, access to and consumption of fruits and vegetables, EDNP food and sweet drinks, time spent in screen-based activities and outdoors. Outcome measures assessed at baseline and 10 months.
Starting date2007
Contact informationJillian Adams, North Coast Area Health Service. jillian.adams@ncahs.health.nsw.gov.au
Notes 

Barlow 2008

Trial name or titleEmpowering Mothers to Prevent Obesity at Weaning
Methods 
ParticipantsWomen with pre-pregnancy obesity (BMI >35).
InterventionsFeasibility RCT of the effectiveness of an intervention aimed at empowering mothers to prevent obesity at weaning
Outcomes 
Starting date01/04/2007 Project End Date: 31/08/2009
Contact informationJane Barlow, Professor of Public Health in the Early Years, University of Warwick, Conventary.  Jane.barlow@warwick.ac.uk
Notes 

Campbell 2008

Trial name or titleThe Infant Food Activity and Nutrition Trial (INFANT) an early intervention to prevent childhood obesity: cluster-randomised controlled trial
MethodsCluster RCT (with first-time parent groups as the unit of randomisation) to be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres in Victoria, Australia. Groups randomly allocated to intervention or control groups.
ParticipantsFirst-time parents and their new born children who attend first-time parents groups
InterventionsThe INFANT project will employ an anticipatory guidance approach to support first-time parents in skilled approaches to their infants emerging dietary, physical activity and sedentary behaviours.  The intervention will be delivered by an experienced dietician during infants’ first 18 months of life at first-time parents groups within Maternal and Chid Health (MCH) centers.
OutcomesEarly health promotion programme delivered to first-time parents in their existing social groups promotes healthy eating, physical activity and reduced sedentary behaviour.
Starting dateTBC
Contact information

Dr Karen Campbell

Karen.campbell@deakin.edu.au

NotesISRCTN81847050

Daniels 2008

Trial name or titlePositive feeding practices and food preferences in very early childhood: an innovative approach to obesity prevention
Methods 
ParticipantsFirst time mothers of healthy infants 4-7 months at enrolment
InterventionsWill provide anticipatory guidance via 2 x 12 week parent education and peer support modules (6x1.5 hours sessions), each followed by 6 x monthly maintenance contact (choice support phone/email)  The modules will commence at ages 4-7m and 13-16m to coincide with establishment of solid feeding and development of autonomy and independence.
Outcomesassessed at baseline (age 4-7m), 9 m (age 13-16 m) and 18 m (final, age 2y).
Starting date 
Contact informationProfessor Lynn Daniels, Institute of Healthand Biomedical Innovation (IHBI), School of Public Health (SPH), Queensland University of Technology  l2.daniels@qut.edu.au
Notes 

Haby 2009

Trial name or title

‘Go for your life’ Health Promoting Communities: Being Active Eating Well

HPC: BAEW

MethodsA quasi-experimental multi-level intervention demonstration project with comparison group to increase community capacity to promote healthy eating and physical activity, measured by changes in community capacity, environments, health behaviours and anthropometry.
Participants

Inclusion criteria: Each project has a primary and secondary target group, with comparison groups selected to match primary targets. Target groups include children 0-12, adolescents 12-18, young people newly arrived to Australia, families, carers, working adults, older adults, seniors and an indigenous community.

Exclusion criteria: None

Age minimum: 0 No limit
Age maximum: 0 No limit
Gender: Both males and females

InterventionsIntervention groups: multiple strategies in schools, workplaces and community organisations to promote healthy eating and physical activity. Examples of strategies include school and workplace food policies, community kitchens and gardens, walking groups, parent education programs, social marketing, training of local professionals and promoting active transport. The duration of the trial is approximately 4 years.
Outcomes

Primary: BMI z-score

Secondary:

BMI

Community capacity to effect behaviour change around overweight and obesity, as evidenced by the development of new structures and partnerships, staff development, community awareness etc (measured by expert assessment)

Prevalence of overweight and obesity, measured by BMI and waist circumference

School and workplace environmental changes, as measured by school/workplace environmental audits and expert assessment.

Waist circumference

Starting date2006
Contact informationMichelle Haby: Michelle.Haby@dhs.vic.gov.au
NotesACTRN12609000892213

Jansen 2008

Trial name or titleLekker Fit!
MethodsCluster RCT in 20 primary schools comparing intervention with control
ParticipantsChildren aged 6-12 years in grades 3 through to 8 within primary schools in Rotterdam with large populations of foreign ethnicity
InterventionsMain components of the intervention are the re-establishment of a professional physical education teacher; three (instead of two) PE classes per week; additional sport and play activities outside school hours; fitness testing; classroom education on health nutrition, active living and healthy lifestyle choices; and the involvement of parents.
OutcomesPrimary outcome measures are BMI, waist circumference and fitness. Secondary outcomes are assessed in a subgroup of grade 6-8 pupils and consist of nutrition and physical activity behaviours and behavioural determinants.
Starting date 
Contact informationWilma Jansen: jansenw@ggd.rotterdam.nl
NotesISRCTN84383524

Jones 2007

Trial name or titleThe HIKCUPS trial: a multi-site ramdomised controlled trial of a combined physical activity skill-development and dietary modification programme in overweight and obese children
MethodsMulti-site randomised controlled trial in overweight/obese children comparing the efficacy of three interventions: 1) a parent-centered dietary modification programme; 2) a child-centered physical activity skill-development programme; and 3) a programme combining both 1 and 2 above.
ParticipantsOverweight/obese 5-9 year old children. Approximately 200 families are being recruited, three cohorts during 2005 and one cohort during 2006 from the Hunter and Illawarra regions of New South Wales, Australia.
InterventionsEach intervention consists of three components: i) 10-weekly face-to-face group sessions; ii) a weekly homework component, completed between each face-to-face session and iii) three telephone calls at monthly intervals following completion of the 10-week programme.
OutcomesThe primary outcome measures are BMI z-score and waist circumference. The secondary outcomes include: metabolic profile, dietary intake, Child Feeding Questionnaire, fundamental movement skill proficiency and perceived competence, objectively measured physical activity, time spent in sedentary activities, proficiency in performing an activity of daily living, and health-related quality of life. Outcome measures are assessed at baseline and at 6-, 12- and 24-months.
Starting date 
Contact informationRachel Jones: rachelj@uow.edu.au
Notes 

Maddison 2009

Trial name or titleThe electronic games to aid motivation to exercise study (eGAME)
MethodsStandard 2-arm parallel RCT. 330 participants will be randomised to receive either an active video game upgrade package or to a control group
ParticipantsChildren aged 10-14 years living in the greater metropolitan Auckland area, who are overweight and play>= two hours of video games per week.
InterventionsIntervention involves an upgrade of children's existing gaming technology to enable them to play active video games at home.
Outcomes

Primary outcome: change in BMI from baseline to 12 and 24 weeks.

Secondary outcomes: changes in % body fat, waist circumference, physical fitness, physical activity (time spent), psychological variables

Starting date 
Contact informationLouise Foley: l.foley@ctru.auckland.ac.nz
Notes 

Mastersson 2006

Trial name or titleeat well be active Community Programs
MethodsControlled before and after study evaluating a five-year intervention conducted during 2006-2010 in 18 preschools, 27 schools and 20 additional community settings (matched with similar numbers of comparison settings by non-random allocation).
ParticipantsRecruited from preschools, schools and community settings in two geographically distinct communities in SA, Australia. All communities were more socio-economic disadvantaged than the State average.
InterventionsIntervention strategies included workforce development and peer education for staff, healthy eating and physical activity policy, infrastructure (such as drinking water facilities and canteen improvements), resources and programs, local marketing and promotion of key messages (fruit and vegetables, water, active play and breastfeeding), and community development via the establishment of local stakeholder action groups.
OutcomesPrimary outcome measures included BMI of preschool children, and BMI and waist circumference of primary school children. Impact indicators included primary school children’s behaviours, attitudes and knowledge; and environments of preschools, primary school and high schools via staff surveys of policy, access, attitudes and knowledge relating to healthy eating, breastfeeding, physical activity and sedentary time. Evaluation measures assessed at baseline and 5 years.
Starting date2005
Contact informationNadia Mastersson, SA Health Nadia.Mastersson@health.sa.gov.au
NotesIntervention implementation concluded June 2010. Final evaluation report released February 2011. http://www.health.sa.gov.au/pehs/branches/health-promotion/ewba/publications.htm

Niederer 2009

Trial name or title 
MethodsCluster RCT conducted in preschools to test a multidisciplinary lifestyle intervention versus control.
ParticipantsTwenty preschool classes in the German and another 20 in the French part of Switzerland (areas with a high migrant population) were selected to participate.
InterventionsThe multidisciplinary lifestyle intervention aimed to increase physical activity and sleep duration, to reinforce healthy nutrition and eating behaviour and to reduce media use. It included children, their parents and the teachers. The intervention included physical activity lessons, adaptation of the built infrastructure, promotion of regional extracurricular physical activity, as well as lessons about nutrition, media use and sleep. It lasted one school year.
OutcomesPrimary outcomes: BMI and aerobic fitness. Secondary outcomes: total and central body fat, motor abilities, physical activity and sleep duration, nutritional behaviour and food intake, media use, quality of life and signs of hyperactivity, attention and spatial working memory ability.
Starting date 
Contact informationIris Niederer: iris.niederer@unibas.ch
NotesNCT00674544

Roberts 2008

Trial name or titleHealthy Youths, Healthy Communities; A community based obesity prevention study in secondary school students.
MethodsA 3-year study in secondary school children of a multi-strategy, community intervention promoting healthy eating and physical activity compared to no specific interventions on changes in body size and composition.
Participants

Inclusion criteria: Inclusion for measurement: male and female students in Forms 3-6 in selected schools in intervention and comparison areas. Minimum age: 12 years, maximum age: 19 years. Inclusion Criteria of schools and community: sample size and ethnic composition, convenience and relevance of location.

Exclusion criteria: Age of student (between 13 years to 19 years)

Age minimum: 13 Years
Age maximum: 19 Years
Gender: Both males and females

InterventionsInterventions are multiple strategies over 3 years within secondary schools and the community to build the community's capacity to promote healthy eating and physical activity. Examples include school food policies, improving school food service, within school and after school physical activity programs, training of teachers, students and community leaders as coordinators, curriculum on healthy eating and physical activities, social marketing, incorporating programs into local government strategic plans.
Outcomes

Primary: Percent body fat

Secondary: BMI measured by BMI z-score.

Prevalence of overweight and obesity assessed by waist circumference.

Quality of life measured using the modified AQol tool.

Starting date2005
Contact informationGraham Roberts: g.roberts@fsm.ac.fj
NotesACTRN12608000345381

Roberts 2008a

Trial name or titleMa'alahi Youth Project; The effects of a community based intervention promoting healthy eating and physical activity in secondary school students on changes in body size and composition.
MethodsA 3-year study in secondary school children of a multi-strategy, community driven intervention promoting healthy eating and physical activity compared to no specific interventions on changes in body size and composition.
Participants

Inclusion criteria: Inclusion for measurement: male and female students in Forms 1-6 in selected schools in intervention and comparison areas. Inclusion Criteria for schools and communities: Sample size of students and convenience and relevance of location.

Exclusion criteria: Age of student (between 12 years to 19 years)

Age minimum: 11 Years
Age maximum: 19 Years
Gender: Both males and females

InterventionsInterventions are multiple strategies over 3 years within the communities and selected schools to build the community's capacity to promote healthy eating and physical activity. The promotional strategies are implemented by the Obesity Prevention In Community (OPIC) Intervention Officers and National Health Promotion Officers from the Ministry of Health. Promotional materials used are social marketing (e.g. Billboards, radio programmes, Radio and TV spots), community based sports competition, leaflet distribution on importance / composition of healthy breakfast, helping in the set up of vegetable gardens through seedling distribution and implementing the National Canteen Guidelines in school canteens. Aerobics sessions and competitions are also promoted both in schools and village communities.
OutcomesPrimary: Percent body fatSecondary: BMI measured by BMI z-score.Prevalence of overweight and obesity assessed by waist circumference.Quality of life measured using the modified AQol tool.
Starting date2005
Contact informationGraham Roberts: g.roberts@fsm.ac.fj
NotesACTRN12608000346370

Shrewsbury 2009

Trial name or titleThe Loozit Study
MethodsRCT with two arms. One arm receives the Loozit group weight management programme and the other arm received the same Loozit group weight management programme plus additional therapeutic contact.
ParticipantsAim is to recruit 168 overweight and obese 13-16 year olds in Sydney, Australia. Recruitment via schools, media coverage, health professionals and several community organisations.
InterventionsThe group weight management programme consists of two phases. Phase 1 involved seven weekly group session held separately for adolescents and their parents. Phase 2 involves a further seven group sessions held regularly, for adolescents only, until two years follow-up. Additional therapeutic contact is provided to one of the study groups approximately once per fortnight during phase 2 only.
OutcomesAssessed at 2, 12, and 24 months. BMI z-score, waist z-score, metabolic profile indicators, physical activity, sedentary behaviour, eating patterns and psychosocial well being
Starting dateRecruitment began: May 2006. 24 month follow-up to be completed by July 2011.
Contact informationVanessa Shrewsbury: VanessS2@chw.edu.au
Notes 

Swinburn 2007

Trial name or titleIt's Your Move! A community-based obesity prevention study in secondary school children
MethodsA 3-year study in secondary school children of a multi-strategy, community intervention promoting healthy eating and physical activity compared to no specific interventions on changes in body size and composition
Participants

Inclusion criteria: Students in Years 7-11 in selected schools in intervention and comparison areas.

Exclusion criteria: Nil

Age minimum: 12 Years
Age maximum: 19 Years
Gender: Both males and females

InterventionsInterventions are multiple strategies over 3 years within secondary schools and the community to build the community's capacity to promote healthy eating and physical activity. Examples include school food policies, improving school food service, within school and after school physical activity programs, training for coordinators and student ambassadors, curriculum on healthy eating and healthy bodies, activities around avoiding fad diets and creating body size acceptance, social marketing, incorporating programs into local government strategic plans.
Outcomes

Primary: percent body fat

Secondary: BMI, BMI z-score, prevalence of overweight and obesity, waist circumference, behavioural indicators of healthy eating and physical activity, quality of life, and knowledge indicators.

Starting date2005
Contact informationBoyd Swinburn: boyd.swinburn@deakin.edu.au
NotesACTRN12607000257460

Swinburn 2007a

Trial name or titleRomp & Chomp: A community-based intervention programme to promote healthy eating and physical activity in under 5s in the City of Greater Geelong
MethodsA study in pre-school children of multiple strategies to increase the community's capacity to promote healthy eating and physical activity compared to no specific interventions on the prevalence of overweight and obesity
Participants

Inclusion criteria: Inclusion for anthropometry: All children attending Maternal and Child Health (MCH) Key Age and Stages visits for 2 and 3.5 years Inclusion for behaviours: Parents attending MCH 2 and 3.5 year Age and Stage visits within the data collection time period. Inclusions for Settings audits: Kindergartens, long daycare, family daycare settings in the intervention and comparison areas.

Exclusion criteria: Exclusion for anthropometry: participants with missing data and outlying data indicating data entry errors. Exclusions for audits: nil

Age minimum: 2 Years
Age maximum: 4 Years
Gender: Both males and females

InterventionsIntervention: Multiple strategies over 3 years (2005-2008) to increase community capacity to increase healthy eating and physical activity in pre-school children. Examples of strategies include food policies in child care settings, active play programs, social marketing, promotion of water, training of early childhood professionals, and parent education.
OutcomesPrimary: Change in the prevalence of overweight and obesity calculated from measured height and weight from routinely collected anthropometry in 2 and 3.5 year olds.
Starting date2005
Contact informationBoyd Swinburn: boyd.swinburn@deakin.edu.au
NotesACTRN12607000374460

Veldhuis 2009

Trial name or titleBe active, eat right
MethodsCluster RCT to assess a prevention protocol developed within Youth Health Care in 2005
Participants5-year-old children included by 44 Youth Health Care teams randomised within 9 Municipal Health Services in The Netherlands.
InterventionsWhen a child in the intervention group is detected with overweight according to BMI cut-offs, the prevention protocol is applied. According to the protocol, parents of overweight children are invited for up to three counselling session during which they receive personal advice about a healthy lifestyle, and are assisted with behavioural change.
OutcomesPrimary outcomes are BMI and waist circumference of the children. Parents complete questionnaires to assess secondary outcome measures: levels of overweight inducing/reducing behaviours, parenting styles/practices/attitudes, health-related quality of life of children, possible adverse effects. Data collected at baseline, 12 and 24 months follow-up. Process and cost-effectiveness evaluation will also be conducted.
Starting date 
Contact informationLydian Veldhuis: l.veldhuis@erasmusmc.nl
NotesISRCTN04965410

Waters 2007

Trial name or titleFun 'n' healthy in Moreland
Methods 
ParticipantsPrimary School Children in 24 Schools in Moreland, an inner city suburb of Melbourne, Australia
InterventionsIntervention is a facilitated approach to supporting school to implement an evidence based approach with interventions based on priorities within the school, ensuring focus on diet, physical activity and child health and well being.
OutcomesBMI, child health and well being,
Starting date2004-2010
Contact informationhttp://www.mchs.org.au/
Notes

Victorian Government Departments of Sport and Recreation and Human Services

ACTRN12607000385448

Wen 2008

Trial name or titleEarly intervention of multiple home visits to prevent childhood obesity in a disadvantaged population: a home-based randomised controlled trial (Healthy Beginnings Trial)
Methods 
ParticipantsFirst time mothers who are 24 to 34 weeks pregnant.
InterventionsComprises of eight home visits from a specially trained community nurse over two years and pro-active telephone support between the visits.
Outcomesa) duration of breastfeeding measured at 6-12 months b) introduction of solids measured at 4 and 6 months c) nutrition, physical activity and television viewing measured at 24 months, and d) overweight/obesity status at age 2 and 5 years
Starting dateTBC
Contact informationLi Ming Wen: lmwen@email.cs.nsw.gov.au
Notes 

Williamson 2008

  1. a

    BMI: body mas index
    BMIz: standatdised body mss index
    FMS: Fundamental Movement Skills
    RCT: randomised contorlled trial

Trial name or titleLouisiana (LA) Health
MethodsThree treatment arms will be compared in a cluster RCT design. A fourth treatment arm will serve as a nonrandomised control condition.
Participants23 school systems in Louisiana, USA were invited to participate and students were recruited from participating schools.
Interventions