Obelix Trial

The objective of this study is to compare a newly developed ambulatory programme with a maximal clinical intervention programme. Patients were randomly assigned to either clinical treatment, involving hospitalization for 26 weeks, or an intensive ambulatory programme. Both treatment programmes consist of an intensive family-based intervention including exercise, nutrition and behaviour modification for the children and their caregiver(s). In a pilot study we found that our clinical treatment programme could achieve a sustainable decrease in BMI for 1 year after fisnishing a six month treatment programme. Therefore a randomized controlled trial was set up to evaluate whether the efficacy of an inpatient treatment programme for morbidly obese children (8-18y) is superior to the best possible care in an ambulatory setting. To compare changes in BMI and BMI=z-scores, body composition, body circumferences, insulin sensitivity, bloodpressure, liverfunctiontest, lipid profiles and exercisetest.

In morbid obesity in childhood (8-18y)inpatient treatment is superior to ambultory treatment regarding decrease in BMI-scores.

T0 Start of treatment programme;

T1 after 26 weeks of treatment;

T2 after a follow up of 12 months;

T3 after a follow up of 24 months.

Inpatient treatment arm: multidisciplinary obesity treatment (diet, exercise and behaviour) for 26 weeks. Parents classes obligatory. Child is hospitalized monday through friday. Weekends at home with homework for the whole family.

Ambulatory treatment arm:
multidisciplinary obesity treatment (diet, exercise and behaviour) for 26 weeks. Parents classes obligatory. Child and parent(s) visit outpatient clinic 12 times in 26 weeks for a 4-6 hour programme per visit.