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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00988754
First Posted: October 2, 2009
Last Update Posted: October 13, 2017
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.
Collaborator:
Bavarian State Ministry of Health and Care
Information provided by (Responsible Party):
Technische Universität München
October 1, 2009
October 2, 2009
October 13, 2017
July 2008
July 2012   (Final data collection date for primary outcome measure)
Daily physical activity > 60 minutes [ Time Frame: 4 years ]
number of days with physical activity > 60 minutes
Daily physical activity > 60 minutes [ Time Frame: 4 years ]
Complete list of historical versions of study NCT00988754 on ClinicalTrials.gov Archive Site
  • Physical fitness [ Time Frame: 4 years ]
    6-item-test battery (points)
  • Anthropometric parameters [ Time Frame: 4 years ]
    BMI (kg/m2), BMI-SDS, Waist and upper arm circumferences (cm), skinfold thickness (mm), Blood pressure (mm Hg)
  • 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)
  • Retinal vascular caliber [ Time Frame: 4 years ]
    Central retinal arteriolar (CRAE) and venular (CRVE) vessel diameters, arteriolar-to-venular-ratio
  • Lifestyle and socio-economic index [ Time Frame: 4 years ]
    Questionnaire concerning eating pattern, sitting behavior, smoking, drinking, school level parents, nationality children and parents)
  • Arterial stiffness [ Time Frame: 4 years ]
    Sphygmograph
  • Quality of life [ Time Frame: 4 years ]
    Questionnaire (KINDL-R)
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 ]
Not Provided
Not Provided
 
School Based Health Promotion Program in Secondary Schools
School Children and Adolescents as Health Experts - Step 3
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Obesity
  • Cardiovascular Risk
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
  • 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
    Intervention: Behavioral: School children and adolescents as health experts
  • No Intervention: B
    Medical examination and information on a healthy lifestyle.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
595
December 2012
July 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
9 Years to 14 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00988754
LP00001 FA 08 07-26
No
Not Provided
Not Provided
Technische Universität München
Technische Universität München
Bavarian State Ministry of Health and Care
Study Chair: Martin Halle, Prof., M.D. Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany
Technische Universität München
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP