GRIB Forsoeget-2004 (GRIB-2004)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00554645
Recruitment Status : Completed
First Posted : November 7, 2007
Last Update Posted : November 7, 2007
Den Sundhedsvidenskabelige Forskningsfond (Region 3)
Østdansk Sundhedsvidenskabeligt Forskningsforums Konsuletttjeneste
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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?

Condition or disease Intervention/treatment Phase
Overweight Behavioral: multi-disciplinary group intervention Other: traditional information Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Disciplinary Group Intervention Versus Traditional Information Towards Severely Overweight Children and Their Families -
Study Start Date : January 2004
Actual Study Completion Date : November 2007

Arm Intervention/treatment
Experimental: 1
Multi-disciplinary group 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
Active Comparator: 2
traditional information
Other: traditional information
1 session of nutritional advise for parents and child and 1 follow-up after one month

Primary Outcome Measures :
  1. Body Mass Index [ Time Frame: Baseline, 6 months, 12 months ]

Secondary Outcome Measures :
  1. fat% measured by DEXA scan, Hip/waist ratio, skinfold [ Time Frame: Baseline, 6 months, 12 months ]

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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Weight compared to hight over 135% of the Danish norms (

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00554645

Peaditrisk enhed, Helse vej 2
Hilleroed, Regionh, Denmark, 3400
Sponsors and Collaborators
Den Sundhedsvidenskabelige Forskningsfond (Region 3)
Østdansk Sundhedsvidenskabeligt Forskningsforums Konsuletttjeneste
Study Chair: Ole Andersen, dr. med. former chief administration physician, peadiatrisk Enhed, Hilleroed Sygehus, 3400 Hilleroed Identifier: NCT00554645     History of Changes
Other Study ID Numbers: ø-2003-1-40
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: November 7, 2007
Last Verified: November 2007

Keywords provided by Forskningspuljen:
psychological intervention

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms