GRIB Forsoeget-2004 (GRIB-2004)

This study has been completed.
Sponsor:
Collaborators:
Den Sundhedsvidenskabelige Forskningsfond (Region 3)
Østdansk Sundhedsvidenskabeligt forskningsforums konsuletttjeneste
Information provided by:
Forskningspuljen
ClinicalTrials.gov Identifier:
NCT00554645
First received: November 5, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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 Intervention Phase
Overweight
Behavioral: multi-disciplinary group intervention
Other: traditional information
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Disciplinary Group Intervention Versus Traditional Information Towards Severely Overweight Children and Their Families -

Further study details as provided by Forskningspuljen:

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

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

Enrollment: 45
Study Start Date: January 2004
Study Completion Date: November 2007
Arms Assigned Interventions
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

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

Ages Eligible for Study:   10 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554645

Locations
Denmark
Peaditrisk enhed, Helse vej 2
Hilleroed, Regionh, Denmark, 3400
Sponsors and Collaborators
Forskningspuljen
Den Sundhedsvidenskabelige Forskningsfond (Region 3)
Østdansk Sundhedsvidenskabeligt forskningsforums konsuletttjeneste
Investigators
Study Chair: Ole Andersen, dr. med. former chief administration physician, peadiatrisk Enhed, Hilleroed Sygehus, 3400 Hilleroed
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00554645     History of Changes
Other Study ID Numbers: ø-2003-1-40
Study First Received: November 5, 2007
Last Updated: November 5, 2007
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Forskningspuljen:
obesity
children
psychological intervention

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014