School Based Health Promotion Program in Secondary Schools (JuvenTUM 3)

October 12, 2017 updated by: Technical University of Munich

School Children and Adolescents as Health Experts - Step 3

The purpose of the study is to determine whether a school based health promotion program in secondary schools is effective with respect to an increase of physical activity, physical fitness and health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Current understanding of physical activity in childhood demonstrates the health benefits of regular exercise, such as improved cardiovascular fitness, skeletal health and prevention of overweight and obesity. The children obtained weekly health education lessons from their teachers to increase the physical activity in and outside of school and to improve health behavior (healthy food, no drugs) as well as the general well-being of children.

Monthly training for teachers and regular training (2-3x/year) for the parents complete the intervention.

Study Type

Interventional

Enrollment (Actual)

595

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80992
        • Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children in the 1. grade of secondary General Schools or Intermediate Schools with written consent from the parents in the greater Munich area

Exclusion Criteria:

  • Children without written consent from their parents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Medical examination once per year, school and family-based lifestyle intervention including a weekly health lesson, school-affiliation to sports clubs and regularly trainings for teachers and parents
Behavioral: School children and adolescents as health experts
Experimental group: Weekly health lesson for children; Monthly training for teacher; 2-3 trainings/year for the parents
No Intervention: B
Medical examination and information on a healthy lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily physical activity > 60 minutes
Time Frame: 4 years
number of days with physical activity > 60 minutes
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical fitness
Time Frame: 4 years
6-item-test battery (points)
4 years
Anthropometric parameters
Time Frame: 4 years
BMI (kg/m2), BMI-SDS, Waist and upper arm circumferences (cm), skinfold thickness (mm), Blood pressure (mm Hg)
4 years
Blood samples
Time Frame: 4 years
HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl), Triglycerides (mg/dl), Glucose (mg/dl), Insulin (µU/ml), Leptin (ng/ml), Adiponectin (µg/ml), Il-6 (pg/ml), hsCRP (mg/L)
4 years
Retinal vascular caliber
Time Frame: 4 years
Central retinal arteriolar (CRAE) and venular (CRVE) vessel diameters, arteriolar-to-venular-ratio
4 years
Lifestyle and socio-economic index
Time Frame: 4 years
Questionnaire concerning eating pattern, sitting behavior, smoking, drinking, school level parents, nationality children and parents)
4 years
Arterial stiffness
Time Frame: 4 years
Sphygmograph
4 years
Quality of life
Time Frame: 4 years
Questionnaire (KINDL-R)
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Collaborators

Bavarian State Ministry of Health and Care

Investigators

  • Study Chair: Martin Halle, Prof., M.D., Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (Estimate)

October 2, 2009

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP00001 FA 08 07-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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