Treatment of Overweight Children and Adolescents

This study has been completed.

Sponsor:

Collaborator:

University of Bremen

Information provided by:

University of Witten/Herdecke

ClinicalTrials.gov Identifier:

NCT00422916

First received: January 16, 2007

Last updated: January 10, 2012

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

January 16, 2007

Last Updated Date

January 10, 2012

Start Date ^ICMJE

January 2007

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

change of weight status

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00422916 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change of eating and exercise behaviour
change of quality of life

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment of Overweight Children and Adolescents

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Overweight

Intervention ^ICMJE

Behavioral: behavioral intervention

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

overweight children

Exclusion Criteria:

primary disease

Gender

Both

Ages

8 Years to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00422916

Other Study ID Numbers ^ICMJE

GFEL011174505

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Witten/Herdecke

Collaborators ^ICMJE

University of Bremen

Investigators ^ICMJE

Study Chair:

Petra Kolip, Prof

University of Bremen, Germany

Information Provided By

University of Witten/Herdecke

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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