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

Tracking Information

First Received Date ^ICMJE

February 14, 2008

Last Updated Date

February 25, 2008

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00623844 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prevention Through Activity in Kindergarten Trial

Official Title ^ICMJE

Prevention Through Acitivity in Kindergarten Trial

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Child, Preschool

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
Intervention: Behavioral: physical activity
No Intervention: 2
Keep usual activities in kindergarten

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

718

Estimated Completion Date

October 2008

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Children in participating kindergartens

Exclusion Criteria:

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

Gender

Both

Ages

43 Months to 67 Months

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00623844

Other Study ID Numbers ^ICMJE

BMBF 01EL0606

Has Data Monitoring Committee

Responsible Party

Helge Hebestreit, University of Wuerzburg

Study Sponsor ^ICMJE

University of Wuerzburg

Collaborators ^ICMJE

Gmünder ErsatzKasse GEK
University of Cologne

Investigators ^ICMJE

Principal Investigator:

Helge Hebestreit, MD, PhD

University of Wuerzburg

Information Provided By

University of Wuerzburg

Verification Date

February 2008

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

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