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NCT00422916 Clinical Trial

Treatment of Overweight Children and Adolescents

Overweight Clinical Trial

Official title:
Evaluation of the Intervention Program "Obeldicks Light" for Overweight Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00422916
Other study ID # GFEL011174505
Secondary ID
Status Completed
Phase N/A
First received January 16, 2007
Last updated October 24, 2016
Start date January 2007
Est. completion date December 2010

Study information
Verified date October 2016
Source University of Witten/Herdecke
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date December 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 16 Years
Eligibility Inclusion Criteria:

- overweight children

Exclusion Criteria:

- primary disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• behavioral intervention

Locations
Country Name City State
Germany Vestische Youth Hospital Datteln

Sponsors (2)
Lead Sponsor Collaborator
University of Witten/Herdecke University of Bremen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary change of weight status 6 months No
Secondary Change of eating and exercise behaviour 6 months No
Secondary change of quality of life 6 months No
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