Prevention Through Activity in Kindergarten Trial

Study Overview
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Brief Summary
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Objectives: The PAKT project shall evaluate the effects of an exercise intervention in kindergarten combined with an educational training of parents and kindergarten teachers on behavior and health status of children. Study design: Baseline measurements were performed on more than 700 kindergarten children aged 43-67 months in May to July 2007. The kindergartens are located in and around Wuerzburg in Germany. Kindergartens were then randomized in an intervention (21 kindergartens) and a control (20 kindergartens) group. The intervention group offers a daily exercise class lasting at least 30 min. Parents and teachers of the children in the intervention program receive educational training. In addition, the children have activity homework involving the entire family. The control kindergartens keep their routine. Follow-up measurements of physical activity (actigraph), motor skills, body mass index, skinfold thickness, and blood pressure take place in January/February 2008, June/July 2008, and September/October 2008. The number of accidents in and outside of the kindergartens and the number of children missing the kindergarten due to infections are monitored continuously. Use of results: If the PAKT program should proof effective, the results will be published in scientific journals and made public using the press. With the help of the GEK, the program will then be implemented nationwide in kindergartens.

Official Title
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Prevention Through Acitivity in Kindergarten Trial

Conditions
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Child, Preschool

Intervention / Treatment
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* Behavioral: physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children in participating kindergartens Exclusion Criteria: Health conditions restricting physical activity Age < 43 months or > 67 months

Ages Eligible for Study
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Minimum Age: 43 Months
Maximum Age: 67 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: Intervention<br>Physical activity intervention: structured daily 30-min activity classes at preschool, activity homeworks, parent and teacher education | Behavioral: physical activity<br>* activity program at kindergarten 5 * 30 min per week plus education of parents (letters, flyers, presentations, counselling) plus activity homework for children involving also the families<br>|
| No Intervention: Control<br>Keep usual activities in kindergarten | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Accelerometry over 7 days | baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention | 
| motor skills | Composite score of several motor tasks | baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adiposity | BMI, skinfolds | baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention | 
| blood pressure |  | baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention | 
| accidents |  | baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention | 
| infections |  | baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention | 
| television viewing time |  | baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Physical activity, Obesity, Motor skills, Kindergarten