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Prevention Through Activity in Kindergarten Trial (PAKT)

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ClinicalTrials.gov Identifier: NCT00623844
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : March 31, 2015
Sponsor:
Collaborators:
Gmünder ErsatzKasse GEK
University of Cologne
Information provided by (Responsible Party):
Helge Hebestreit, University of Wuerzburg

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 Type : Interventional  (Clinical Trial)
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 2007
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Physical activity [ Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention ]
    Accelerometry over 7 days

  2. motor skills [ Time Frame: 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 [ Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention ]
    BMI, skinfolds

  2. blood pressure [ Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention ]
  3. accidents [ Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention ]
  4. infections [ Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention ]
  5. television viewing time [ Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   43 Months to 67 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children in participating kindergartens

Exclusion Criteria:

  • Health conditions restricting physical activity
  • Age < 43 months or > 67 months

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): NCT00623844


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helge Hebestreit, Prof. Dr. med., University of Wuerzburg
ClinicalTrials.gov Identifier: NCT00623844     History of Changes
Other Study ID Numbers: BMBF 01EL0606
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: December 2014

Keywords provided by Helge Hebestreit, University of Wuerzburg:
Prevention
Physical activity
Obesity
Motor skills
Kindergarten