JuvenTUM 3: School Based Health Promotion Program in Secondary Schools

Sponsor
Technische Universität München (Other)
Overall Status
Completed
CT.gov ID
NCT00988754
Collaborator
Bavarian State Ministry of Health and Care (Other)
595
1
2
53
11.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: School children and adolescents as health experts
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
595 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
School Children and Adolescents as Health Experts - Step 3
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Daily physical activity > 60 minutes [4 years]

    number of days with physical activity > 60 minutes

Secondary Outcome Measures

  1. Physical fitness [4 years]

    6-item-test battery (points)

  2. Anthropometric parameters [4 years]

    BMI (kg/m2), BMI-SDS, Waist and upper arm circumferences (cm), skinfold thickness (mm), Blood pressure (mm Hg)

  3. Blood samples [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. Retinal vascular caliber [4 years]

    Central retinal arteriolar (CRAE) and venular (CRVE) vessel diameters, arteriolar-to-venular-ratio

  5. Lifestyle and socio-economic index [4 years]

    Questionnaire concerning eating pattern, sitting behavior, smoking, drinking, school level parents, nationality children and parents)

  6. Arterial stiffness [4 years]

    Sphygmograph

  7. Quality of life [4 years]

    Questionnaire (KINDL-R)

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich Munich Bavaria Germany 80992

Sponsors and Collaborators

  • Technische Universität München
  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00988754
Other Study ID Numbers:
  • LP00001 FA 08 07-26
First Posted:
Oct 2, 2009
Last Update Posted:
Oct 13, 2017
Last Verified:
Oct 1, 2017

Study Results

No Results Posted as of Oct 13, 2017