School Based Health Promotion Program in Secondary Schools

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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School Children and Adolescents as Health Experts - Step 3

Conditions
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Obesity, Cardiovascular Risk

Intervention / Treatment
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* Behavioral: School children and adolescents as health experts


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>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<br>* Experimental group: Weekly health lesson for children; Monthly training for teacher; 2-3 trainings/year for the parents<br>|
| No Intervention: B<br>Medical examination and information on a healthy lifestyle. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical fitness | 6-item-test battery (points) | 4 years | 
| Anthropometric parameters | BMI (kg/m2), BMI-SDS, Waist and upper arm circumferences (cm), skinfold thickness (mm), Blood pressure (mm Hg) | 4 years | 
| Blood samples | 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 | Central retinal arteriolar (CRAE) and venular (CRVE) vessel diameters, arteriolar-to-venular-ratio | 4 years | 
| Lifestyle and socio-economic index | Questionnaire concerning eating pattern, sitting behavior, smoking, drinking, school level parents, nationality children and parents) | 4 years | 
| Arterial stiffness | Sphygmograph | 4 years | 
| Quality of life | Questionnaire (KINDL-R) | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, childhood and adolescence, school and family-based lifestyle intervention, cardiovascular risk, Obesity and associated cardiovascular risk in childhood and adolescence,, health behaviour