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

History of Changes

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:

MedlinePlus related topics: Obesity Toddler Health

U.S. FDA Resources

Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	718
Study Start Date:	May 2007
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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: 2 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

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):

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.

Responsible Party:	Helge Hebestreit, University of Wuerzburg
ClinicalTrials.gov Identifier:	NCT00623844 History of Changes
Other Study ID Numbers:	BMBF 01EL0606
Study First Received:	February 14, 2008
Last Updated:	February 25, 2008
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 22, 2013

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