Prevention Through Activity in Kindergarten Trial (PAKT)

This study has been completed.
Sponsor:
Collaborators:
Gmünder ErsatzKasse GEK
University of Cologne
Information provided by (Responsible Party):
Helge Hebestreit, University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT00623844
First received: February 14, 2008
Last updated: March 30, 2015
Last verified: December 2014
  Purpose

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

  Eligibility

Ages Eligible for Study:   43 Months to 67 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children in participating kindergartens

Exclusion Criteria:

  • Health conditions restricting physical activity
  • Age < 43 months or > 67 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623844

Sponsors and Collaborators
University of Wuerzburg
Gmünder ErsatzKasse GEK
University of Cologne
Investigators
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 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
Study First Received: February 14, 2008
Last Updated: March 30, 2015
Health Authority: Germany: Federal Ministry of Education and Research

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

ClinicalTrials.gov processed this record on May 26, 2015