GRIB Forsoeget-2004

Study Overview
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Brief Summary
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The difficulties in loosing weight may not stem from lack og knowledge about nutrition, as implied by the standard treatment but from difficulties in following the advice. The hypothesis is, that revealing and addressing these difficulties psychotherapeutically may be more efficient in obtaining weight reduction. The effect of psychological group treatment of severely overweight children and their parents is compared with traditional nutritional information. In other words: Which is better: back-up or enlightenment?

Detailed Description
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At on-set the children get a medical examination, blood-tests, measurement of height, weight, skin-fold, waist and hip. Children and parents fill out questionnaires on social and educational background as well as motivation and expectations to the treatment. All Children are thereafter randomised into two groups:multi-disciplinary group intervention versus traditional information. The randomisation is stratified according to gender and degree of overweight (135%-145% and >145%) supposing that the degree of overweight may mirror the difficulties in loosing weight. The experimental intervention consists of one lecture of general nutrition, weekly psychological group sessions for the children followed by physical exercise, and separate bi-monthly group sessions for the parents. After six months children and parents go to separate group sessions once a month for six months. The control group is offered nutritional advice once with a brief follow-up after one month. The height and weight of the children is measured every month, and the fat % is measured with DEXA-scanning at on-set, after six months, and after twelve months

Official Title
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Multi-Disciplinary Group Intervention Versus Traditional Information Towards Severely Overweight Children and Their Families -

Conditions
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Overweight

Intervention / Treatment
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* Behavioral: multi-disciplinary group intervention
* Other: traditional information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Weight compared to hight over 135% of the Danish norms (www.peadiatri.dk) Exclusion Criteria: None of the parents wants to participate Diagnosed somatic course of overweight Parents or children do not speak danish Sever physical handicap Psychiatric illness or mental retardation in children or parents Severe child abuse Siblings participation in the trail.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Multi-disciplinary group intervention | Behavioral: multi-disciplinary group intervention<br>* children:weekley session in 6 months, monthly sessions for 6 months parents: bi-monthly sessions for 6 months, monthly sessions for 6 months<br>|
| Active Comparator: 2<br>traditional information | Other: traditional information<br>* 1 session of nutritional advise for parents and child and 1 follow-up after one month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index |  | Baseline, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fat% measured by DEXA scan, Hip/waist ratio, skinfold |  | Baseline, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, children, psychological intervention