Prevention Through Activity in Kindergarten Trial (PAKT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University of Wuerzburg.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Gmünder ErsatzKasse GEK
University of Cologne
Information provided by:
University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT00623844
First received: February 14, 2008
Last updated: February 25, 2008
Last verified: February 2008

February 14, 2008
February 25, 2008
May 2007
October 2008   (final data collection date for primary outcome measure)
  • Physical activity [ Time Frame: baseline, after 4-5, 8-9, and 12-13 months of intervention ] [ Designated as safety issue: No ]
  • motor skills [ Time Frame: baseline, after 4-5, 8-9, and 12-13 months of intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00623844 on ClinicalTrials.gov Archive Site
  • adiposity [ Time Frame: baseline, after 4-5, 8-9, and 12-13 months of intervention ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: baseline, after 4-5, 8-9, and 12-13 months of intervention ] [ Designated as safety issue: No ]
  • accidents [ Time Frame: baseline, after 4-5, 8-9, and 12-13 months of intervention ] [ Designated as safety issue: Yes ]
  • infections [ Time Frame: baseline, after 4-5, 8-9, and 12-13 months ] [ Designated as safety issue: Yes ]
  • television viewing time [ Time Frame: baseline, after 4-5, 8-9, and 12-13 months of intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prevention Through Activity in Kindergarten Trial
Prevention Through Acitivity in Kindergarten Trial

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Child, Preschool
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
  • Experimental: 1
    Intervention: Behavioral: physical activity
  • No Intervention: 2
    Keep usual activities in kindergarten
Roth K, Mauer S, Obinger M, Ruf KC, Graf C, Kriemler S, Lenz D, Lehmacher W, Hebestreit H. Prevention through Activity in Kindergarten Trial (PAKT): a cluster randomised controlled trial to assess the effects of an activity intervention in preschool children. BMC Public Health. 2010 Jul 12;10:410.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
718
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children in participating kindergartens

Exclusion Criteria:

  • Health conditions restricting physical activity
  • Age < 43 months or > 67 months
Both
43 Months to 67 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00623844
BMBF 01EL0606
No
Helge Hebestreit, University of Wuerzburg
University of Wuerzburg
  • Gmünder ErsatzKasse GEK
  • University of Cologne
Principal Investigator: Helge Hebestreit, MD, PhD University of Wuerzburg
University of Wuerzburg
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP