• Childhood;
  • compliance;
  • obesity;
  • orlistat;
  • safety

Aim: This study investigated orlistat treatment in obese prepubertal children with regard to tolerance, safety and psychological well-being. Methods: 11 healthy, severely obese prepubertal children (age 8.3–12.3 y, body mass index standard deviation score 5.3–9.2) were recruited for a 12wk open treatment. Before, during and after treatment, the participants were investigated by psychological evaluation, blood chemistry, and parameters reflecting obesity and fat mass. Results: The participants were able to comply with the treatment, as indicated by pill counts and self reports, and expressed a desire to continue the treatment after the study period. Gastrointestinal side effects were mild and tolerable. No negative effects on psychological or physical well-being were detected, and the psychological evaluation demonstrated increased avoidance of fattening food, body shape preoccupation and oral control (p= 0.011). The median weight loss was 4.0 kg (range –12.7 to +2.5 kg, p= 0.016) and was highly correlated to decreased fat mass (regression coefficient 0.953, p < 0.01).

Conclusion: This pilot study indicates that obese prepubertal children were able to reduce their fat intake to avoid gastrointestinal side effects. Thus, orlistat may be suitable as a component in behaviour-modification programmes for obese children, and the results prompt a placebo-controlled investigation of its effectiveness in promoting weight loss.