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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by University of Leipzig.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00176371
First received: September 13, 2005
Last updated: September 7, 2007
Last verified: September 2006
History of Changes
  Purpose

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 Intervention
Overweight
 Behavioral: physical exercise

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Improvement of maximal oxygen uptake

Secondary Outcome Measures:
  • Change in body mass index

Estimated Enrollment: 500
Study Start Date: July 2005
Estimated Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   9 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • School class

Exclusion Criteria:

  • Condition precluding exercise
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176371

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

Locations
Germany
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
Investigators
Principal Investigator: Gerhard Schuler, Professor University of Leipzig
  More Information

No publications provided by University of Leipzig

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00176371     History of Changes
Other Study ID Numbers: school project
Study First Received: September 13, 2005
Last Updated: September 7, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by University of Leipzig:
Physical fitness

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013