Prevention Through Activity in Kindergarten Trial

Child, Preschool Clinical Trial

— PAKT  

Official title:

Prevention Through Acitivity in Kindergarten Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623844
• Other study ID #: BMBF 01EL0606
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 14, 2008
• Last updated: March 30, 2015
• Start date: May 2007
• Est. completion date: November 2008

Study information

• Verified date: December 2014
• Source: University of Wuerzburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 718
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 43 Months to 67 Months

Eligibility

Inclusion Criteria:

• Children in participating kindergartens

Exclusion Criteria:

• Health conditions restricting physical activity

• Age < 43 months or > 67 months

Study Design

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

Related Conditions & MeSH terms

• Child, Preschool

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Wuerzburg	Gmünder ErsatzKasse GEK, University of Cologne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity	Accelerometry over 7 days	baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention	No
Primary	motor skills	Composite score of several motor tasks	baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention	No
Secondary	adiposity	BMI, skinfolds	baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention	No
Secondary	blood pressure		baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention	No
Secondary	accidents		baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention	Yes
Secondary	infections		baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention	Yes
Secondary	television viewing time		baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention	No