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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00988754
Recruitment Status : Completed
First Posted : October 2, 2009
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
Bavarian State Ministry of Health and Care
Information provided by (Responsible Party):
Technical University of Munich

Study Description
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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
Obesity Cardiovascular Risk Behavioral: School children and adolescents as health experts Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : July 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2012
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Daily physical activity > 60 minutes [ Time Frame: 4 years ]
    number of days with physical activity > 60 minutes


Secondary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988754


Locations
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Germany
Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich
Munich, Bavaria, Germany, 80992
Sponsors and Collaborators
Technical University of Munich
Bavarian State Ministry of Health and Care
Investigators
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Study Chair: Martin Halle, Prof., M.D. Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Technical University of Munich
ClinicalTrials.gov Identifier: NCT00988754    
Other Study ID Numbers: LP00001 FA 08 07-26
First Posted: October 2, 2009    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Keywords provided by Technical University of Munich:
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:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight