Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Prevention Through Activity in Kindergarten Trial (PAKT)

This study has been completed.
Gmünder ErsatzKasse GEK
University of Cologne
Information provided by (Responsible Party):
Helge Hebestreit, University of Wuerzburg Identifier:
First received: February 14, 2008
Last updated: December 4, 2014
Last verified: December 2014

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 Intervention Phase
Child, Preschool
Behavioral: physical activity
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention Through Acitivity in Kindergarten Trial

Resource links provided by NLM:

Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:
  • Physical activity [ Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention ] [ Designated as safety issue: No ]
    Accelerometry over 7 days

  • motor skills [ Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention ] [ Designated as safety issue: No ]
    Composite score of several motor tasks

Secondary Outcome Measures:
  • adiposity [ Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention ] [ Designated as safety issue: No ]
    BMI, skinfolds

  • blood pressure [ Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention ] [ Designated as safety issue: No ]
  • accidents [ Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention ] [ Designated as safety issue: Yes ]
  • infections [ Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention ] [ Designated as safety issue: Yes ]
  • television viewing time [ Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention ] [ Designated as safety issue: No ]

Enrollment: 718
Study Start Date: May 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   43 Months to 67 Months
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00623844

Sponsors and Collaborators
University of Wuerzburg
Gmünder ErsatzKasse GEK
University of Cologne
Principal Investigator: Helge Hebestreit, MD, PhD University of Wuerzburg
  More Information

No publications provided by University of Wuerzburg

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Helge Hebestreit, Prof. Dr. med., University of Wuerzburg Identifier: NCT00623844     History of Changes
Other Study ID Numbers: BMBF 01EL0606
Study First Received: February 14, 2008
Last Updated: December 4, 2014
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by University of Wuerzburg:
Physical activity
Motor skills
Kindergarten processed this record on February 27, 2015