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Completed

NCT Number: NCT00988754

School Based Health Promotion Program in Secondary Schools

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Risk Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich

Munich, Bavaria, 80992, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

School children and adolescents as health experts

Behavioral

Experimental group: Weekly health lesson for children; Monthly training for teacher; 2-3 trainings/year for the parents

Primary outcomes

  1. Daily physical activity > 60 minutes

    Time frame: 4 years

    number of days with physical activity > 60 minutes

Secondary outcomes

  1. Physical fitness

    Time frame: 4 years

    6-item-test battery (points)

  2. Anthropometric parameters

    Time frame: 4 years

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

  3. 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. Retinal vascular caliber

    Time frame: 4 years

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

  5. Lifestyle and socio-economic index

    Time frame: 4 years

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

  6. Arterial stiffness

    Time frame: 4 years

    Sphygmograph

  7. Quality of life

    Time frame: 4 years

    Questionnaire (KINDL-R)

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Bavarian State Ministry of Health and Care

Registry information

Official study title

School Children and Adolescents as Health Experts - Step 3

Acronym: JuvenTUM 3

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Oct 2, 2009
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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