- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00422916
Treatment of Overweight Children and Adolescents
Evaluation of the Intervention Program "Obeldicks Light" for Overweight Children and Adolescents
The intervention program "Obeldicks light" is developed for overweight children aged 8-16 years. This intervention is gender - and age specific.
The 6-month intervention is based on nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality of structure, process and results of the intervention. 300 participants in a randomised controlled group design will be evaluated at 4 time points: baseline, end of intervention, 6 months after end of intervention and 12 months after end of intervention.Primary outcome measure is change of weight status as standard deviation score of BMI. Drop-outs will be interviewed to improve the intervention.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Datteln, Germany, 45711
- Vestische Youth Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- overweight children
Exclusion Criteria:
- primary disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention arm
Lifestyle Intervention based on Nutrition Treatment, exercise Treatment and behavorial treatment
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|
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No Intervention: waiting list
waiting 6 months for Intervention without any intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
change of weight status
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change of eating and exercise behaviour
Time Frame: 6 months
|
6 months
|
|
change of quality of life
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Petra Kolip, Prof, University of Bremen, Germany
Publications and helpful links
General Publications
- Reinehr T, Bucksch J, Muller A, Finne E, Kolip P. 7-Year follow-up of a lifestyle intervention in overweight children: Comparison to an untreated control group. Clin Nutr. 2018 Oct;37(5):1558-1562. doi: 10.1016/j.clnu.2017.08.017. Epub 2017 Aug 24.
- Finne E, Reinehr T, Schaefer A, Winkel K, Kolip P. Health-related quality of life in overweight German children and adolescents: do treatment-seeking youth have lower quality of life levels? Comparison of a clinical sample with the general population using a multilevel model approach. BMC Public Health. 2013 Jun 8;13:561. doi: 10.1186/1471-2458-13-561.
- Finne E, Reinehr T, Schaefer A, Winkel K, Kolip P. Changes in self-reported and parent-reported health-related quality of life in overweight children and adolescents participating in an outpatient training: findings from a 12-month follow-up study. Health Qual Life Outcomes. 2013 Jan 2;11:1. doi: 10.1186/1477-7525-11-1.
- Reinehr T, Schaefer A, Winkel K, Finne E, Toschke AM, Kolip P. An effective lifestyle intervention in overweight children: findings from a randomized controlled trial on "Obeldicks light". Clin Nutr. 2010 Jun;29(3):331-6. doi: 10.1016/j.clnu.2009.12.010. Epub 2010 Jan 27.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GFEL011174505
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