- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00554645
GRIB Forsoeget-2004 (GRIB-2004)
November 5, 2007 updated by: Forskningspuljen
Multi-Disciplinary Group Intervention Versus Traditional Information Towards Severely Overweight Children and Their Families -
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?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Regionh
-
Hilleroed, Regionh, Denmark, 3400
- Peaditrisk enhed, Helse vej 2
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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
|
1 session of nutritional advise for parents and child and 1 follow-up after one month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body Mass Index
Time Frame: Baseline, 6 months, 12 months
|
Baseline, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
fat% measured by DEXA scan, Hip/waist ratio, skinfold
Time Frame: Baseline, 6 months, 12 months
|
Baseline, 6 months, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Ole Andersen, dr. med., former chief administration physician, peadiatrisk Enhed, Hilleroed Sygehus, 3400 Hilleroed
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
November 5, 2007
First Submitted That Met QC Criteria
November 5, 2007
First Posted (Estimate)
November 7, 2007
Study Record Updates
Last Update Posted (Estimate)
November 7, 2007
Last Update Submitted That Met QC Criteria
November 5, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ø-2003-1-40
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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