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van CCT (UK)

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Obelix Trial

- candidate number2975
- NTR NumberNTR1172
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jan-2008
- Secondary IDsMEC 04/208. 
- Public TitleObelix Trial
- Scientific TitleObelix Trial, a prospective randomised, controlled trial of the effectiveness of two treatment programmes for children with morbid obesity.
- hypothesisIn morbid obesity in childhood (8-18y)inpatient treatment is superior to ambultory treatment regarding decrease in BMI-scores.
- Healt Condition(s) or Problem(s) studiedMorbid obesity
- Inclusion criteria1. Children, 8-18 y, with primary (exogenous, alimentary) obesity;
2. BMI equivalent to or greater then 35 in adults or over;
3. BMI equivalent to or greater then 30 in adults with serious obesity related comorbidity;
4. Conventional treatments have failed.
- Exclusion criteria1. Syndromal/chromosomal related obesity;
2. obesity because of endocrine diseases or obesity inducing medication;
3. boulimia;
4. psychiatric disorders;
5. IQ under 70;
6. no informed consent given.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2004
- planned closingdate6-dec-2008
- Target number of participants90
- InterventionsInpatient 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.
- Primary outcomeBMI decrease after 26 weeks of treatment and after a follow up of 24 months.
- Secondary outcome1. (Decrease of) existing co-morbidities (liverfunction, cholesterol, lipids, oral GTT, bloodpressure, lungfunction, exhaled-NO, bio-impedance);
2. (Increase of) exercise tolerance;
3. (Increase of) fysical activity;
4. (Increase of) Quality of Life.
- TimepointsT0 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.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Secretariaat kinderartsen
- Sponsor/Initiator Koepel Behandelcentrum Chronisch Zieken
- Funding
(Source(s) of Monetary or Material Support)
Koepel Behandelcentrum Chronisch Zieken
- PublicationsAerobic exercise in adolescents with obesity: preliminary evaluation of a modular training program and the modified shuttle test Klijn PHC, Van der Baan-Slootweg, OH, Van Stel, HF, BMC Pediatrics 2007
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD2-jan-2008 - 9-apr-2008

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