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

This study has been completed.
Sponsor:
Collaborator:
Bavarian State Ministry of Environment, Public Health and Consumer Protection
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00988754
First received: October 1, 2009
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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 Intervention
Obesity
Cardiovascular Risk
Behavioral: School children and adolescents as health experts

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: School Children and Adolescents as Health Experts - Step 3

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Daily physical activity > 60 minutes [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical fitness (Munich Fitness Test); Anthropometry (Weight, BMI, waist and upper arm circumference); Lipid profile (TAG, LDL, HDL); Inflammatory marker (hsCRP, IL-6, Adiponectin) Arterial stiffness; Retinal vessel diameter [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 595
Study Start Date: July 2008
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988754

Locations
Germany
Department of Medicine, Division of Prevention and Sports Medicine, Technical University Munich
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Bavarian State Ministry of Environment, Public Health and Consumer Protection
Investigators
Study Chair: Martin Halle, Prof., M.D. Department of Medicine, Division of Prevention and Sports Medicine, Technical University Munich, Germany
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT00988754     History of Changes
Other Study ID Numbers: LP00001 FA 08 07-26
Study First Received: October 1, 2009
Last Updated: December 10, 2012
Health Authority: Germany: Bavarian State Office for Health and Food Safety

Keywords provided by Technische Universität München:
Obesity
childhood and adolescence
school and family-based lifestyle intervention
cardiovascular risk
Obesity and associated cardiovascular risk in childhood and adolescence,
health behaviour

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014