Clinical trial NCT00554645: GRIB Forsoeget-2004
Official title: Multi-Disciplinary Group Intervention Versus Traditional Information Towards Severely Overweight Children and Their Families -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight
Keywords: obesity
children
psychological intervention
Lead sponsor: Forskningspuljen
Sponsor class: OTHER_GOV
Collaborators: name: Den Sundhedsvidenskabelige Forskningsfond (Region 3)
name: Østdansk Sundhedsvidenskabeligt Forskningsforums Konsuletttjeneste
First posted: 2007-11-07
Enrollment: 45
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Body Mass Index
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: fat% measured by DEXA scan, Hip/waist ratio, skinfold
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Hilleroed
country: Denmark
facility: Peaditrisk enhed, Helse vej 2
state: Regionh
Study officials:
affiliation: former chief administration physician, peadiatrisk Enhed, Hilleroed Sygehus, 3400 Hilleroed
name: Ole Andersen, dr. med.
role: STUDY_CHAIR
References: