GRIB Forsoeget-2004

Overweight Clinical Trial

— GRIB-2004  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554645
• Other study ID #: ø-2003-1-40
• Status: Completed
• Phase: Phase 2
• First received: November 5, 2007
• Last updated: November 5, 2007
• Start date: January 2004
• Est. completion date: November 2007

Study information

• Verified date: November 2007
• Source: Forskningspuljen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 15 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight

Intervention

Behavioral:
• multi-disciplinary group intervention
children:weekley session in 6 months, monthly sessions for 6 months parents: bi-monthly sessions for 6 months, monthly sessions for 6 months

Other:
• traditional information
1 session of nutritional advise for parents and child and 1 follow-up after one month

Locations

Country	Name	City	State
Denmark	Peaditrisk enhed, Helse vej 2	Hilleroed	Regionh

Sponsors (3)

Lead Sponsor	Collaborator
Forskningspuljen	Den Sundhedsvidenskabelige Forskningsfond (Region 3), Østdansk Sundhedsvidenskabeligt forskningsforums konsuletttjeneste

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index		Baseline, 6 months, 12 months
Secondary	fat% measured by DEXA scan, Hip/waist ratio, skinfold		Baseline, 6 months, 12 months