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Improvement of Physical Activity and Correction of Body Mass Index in School Children

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ClinicalTrials.gov Identifier: NCT00176371
Recruitment Status : Unknown
Verified September 2006 by University of Leipzig.
Recruitment status was:  Recruiting
First Posted : September 15, 2005
Last Update Posted : September 10, 2007
Information provided by:
University of Leipzig

Brief Summary:

There is an increasing incidence of overweight children in Germany, due to a lack of physical activity.

The aim of this study is to improve physical fitness and activity in school children. Two classes in different schools are provided with additional sport lessons over a period of one year.

Condition or disease Intervention/treatment
Overweight Behavioral: physical exercise

Detailed Description:

The increasing incidence of overweight children in Germany is due to a lack of physical activity and intake of unhealthy food. The importance of physical activity for the prevention of cardiovascular diseases in adults was shown in several trials. Therefore we provide additional sport lessons over the period of one year in two defined schools in Leipzig with the aim to improve physical fitness in school children. Two other classes with the -in germany- usual quantity of sport classes served as control classes.

In all classes at the beginning and at the end of the school year blood samples were taken, and a clinical investigation, a coordination test for children and a spiroergometer were performed. Additionally each child had to fill out a questionnaire.

Endurance training is emphasized in the sport lessons.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : July 2005
Estimated Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Improvement of maximal oxygen uptake

Secondary Outcome Measures :
  1. Change in body mass index

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • School class

Exclusion Criteria:

  • Condition precluding exercise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176371

Contact: Claudia Walther, MD xx49-341-8651428 waltherc@medizin.uni-leipzig.de
Contact: Gerhard Schuler, Professor xx49-341-8651428 schug@medizin.uni-leipzig.de

University of Leipzig Recruiting
Leipzig, Saxony, Germany, 04299
Contact: Claudia Walther, MD    xx49-341-8651428      
Sub-Investigator: Claudia Walther, MD         
Sponsors and Collaborators
University of Leipzig
Principal Investigator: Gerhard Schuler, Professor University of Leipzig