GRIB Forsoeget-2004

Phase 2

Completed

• Conditions: Overweight
• Interventions: Other: traditional information; Behavioral: multi-disciplinary group intervention

• Registration Number: NCT00554645
• Lead Sponsor: Forskningspuljen

Brief Summary

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

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

Study Timeline

• Study Start: 2004-01
• Status Verified: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2007-11-05
• Study First Submitted QC: 2007-11-05
• Last Update Submitted: 2007-11-05
• Study First Posted: 2007-11-07
• Last Update Posted: 2007-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	traditional information	traditional information
1	multi-disciplinary group intervention	Multi-disciplinary group intervention

Primary Outcome Measures

Name	Time	Method
Body Mass Index	Baseline, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
fat% measured by DEXA scan, Hip/waist ratio, skinfold	Baseline, 6 months, 12 months

Trial Locations

Locations (1)

Peaditrisk enhed, Helse vej 2; 🇩🇰 Hilleroed, Regionh, Denmark