GRIB Forsoeget-2004 (GRIB-2004)
Primary Purpose
Overweight
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
multi-disciplinary group intervention
traditional information
Sponsored by

About this trial
This is an interventional treatment trial for Overweight focused on measuring obesity, children, psychological intervention
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.
Sites / Locations
- Peaditrisk enhed, Helse vej 2
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Multi-disciplinary group intervention
traditional information
Outcomes
Primary Outcome Measures
Body Mass Index
Secondary Outcome Measures
fat% measured by DEXA scan, Hip/waist ratio, skinfold
Full Information
NCT ID
NCT00554645
First Posted
November 5, 2007
Last Updated
November 5, 2007
Sponsor
Forskningspuljen
Collaborators
Den Sundhedsvidenskabelige Forskningsfond (Region 3), Østdansk Sundhedsvidenskabeligt Forskningsforums Konsuletttjeneste
1. Study Identification
Unique Protocol Identification Number
NCT00554645
Brief Title
GRIB Forsoeget-2004
Acronym
GRIB-2004
Official Title
Multi-Disciplinary Group Intervention Versus Traditional Information Towards Severely Overweight Children and Their Families -
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Forskningspuljen
Collaborators
Den Sundhedsvidenskabelige Forskningsfond (Region 3), Østdansk Sundhedsvidenskabeligt Forskningsforums Konsuletttjeneste
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
obesity, children, psychological intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Multi-disciplinary group intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
traditional information
Intervention Type
Behavioral
Intervention Name(s)
multi-disciplinary group intervention
Intervention Description
children:weekley session in 6 months, monthly sessions for 6 months parents: bi-monthly sessions for 6 months, monthly sessions for 6 months
Intervention Type
Other
Intervention Name(s)
traditional information
Intervention Description
1 session of nutritional advise for parents and child and 1 follow-up after one month
Primary Outcome Measure Information:
Title
Body Mass Index
Time Frame
Baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
fat% measured by DEXA scan, Hip/waist ratio, skinfold
Time Frame
Baseline, 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole Andersen, dr. med.
Organizational Affiliation
former chief administration physician, peadiatrisk Enhed, Hilleroed Sygehus, 3400 Hilleroed
Official's Role
Study Chair
Facility Information:
Facility Name
Peaditrisk enhed, Helse vej 2
City
Hilleroed
State/Province
Regionh
ZIP/Postal Code
3400
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
GRIB Forsoeget-2004
We'll reach out to this number within 24 hrs