School Based Health Promotion Program in Secondary Schools (JuvenTUM 3)
This study has been completed.
Sponsor:
Technische Universität München
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
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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
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 May 19, 2013