PAKT: Prevention Through Activity in Kindergarten Trial

• Sponsor: University of Wuerzburg (Other)
• Overall Status: Completed
• CT.gov ID: NCT00623844
• Collaborator: Gmünder ErsatzKasse GEK (Other), University of Cologne (Other)
• Enrollment: 718
• Arms: 2
• Duration (Months): 18.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Child, Preschool	Behavioral: physical activity	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 718 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Prevention Through Acitivity in Kindergarten Trial
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Physical activity intervention: structured daily 30-min activity classes at preschool, activity homeworks, parent and teacher education	Behavioral: physical activity; 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
No Intervention: Control Keep usual activities in kindergarten

Outcome Measures

Primary Outcome Measures

1. Physical activity [baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention]

   Accelerometry over 7 days

2. motor skills [baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention]

   Composite score of several motor tasks

Secondary Outcome Measures

1. adiposity [baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention]

   BMI, skinfolds

2. blood pressure [baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention]

3. accidents [baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention]

4. infections [baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention]

5. television viewing time [baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 43 Months to 67 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Children in participating kindergartens

Exclusion Criteria:

• Health conditions restricting physical activity

• Age < 43 months or > 67 months

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Wuerzburg
• Gmünder ErsatzKasse GEK
• University of Cologne

Investigators

• Principal Investigator: Helge Hebestreit, MD, PhD, University of Wuerzburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Helge Hebestreit, Prof. Dr. med., University of Wuerzburg
• ClinicalTrials.gov Identifier: NCT00623844
• Other Study ID Numbers: BMBF 01EL0606
• First Posted: Feb 26, 2008
• Last Update Posted: Mar 31, 2015
• Last Verified: Dec 1, 2014

• Keywords provided by Helge Hebestreit, Prof. Dr. med., University of Wuerzburg: Prevention; Physical activity; Obesity; Motor skills; Kindergarten

Study Results

No Results Posted as of Mar 31, 2015