Prevention Through Activity in Kindergarten Trial

NCT ID: NCT00623844

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 718 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-11-30

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.

Conditions

Child, Preschool

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Physical activity intervention: structured daily 30-min activity classes at preschool, activity homeworks, parent and teacher education

Group Type: EXPERIMENTAL

physical activity

Intervention Type: BEHAVIORAL

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

Control

Keep usual activities in kindergarten

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children in participating kindergartens

Exclusion Criteria

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

• Minimum Eligible Age: 43 Months
• Maximum Eligible Age: 67 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gmünder ErsatzKasse GEK

UNKNOWN

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: collaborator

University of Wuerzburg

OTHER

Sponsor Role: lead

Responsible Party

Helge Hebestreit

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helge Hebestreit, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wuerzburg

References

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. doi: 10.1186/1471-2458-10-410.

Reference Type: DERIVED

PMID: 20624316 (View on PubMed)

Other Identifiers

BMBF 01EL0606

Identifier Type: -

Identifier Source: org_study_id