Clinical trial NCT00623844: Prevention Through Activity in Kindergarten Trial
Official title: Prevention Through Acitivity in Kindergarten Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Child, Preschool
Keywords: Prevention
Physical activity
Obesity
Motor skills
Kindergarten
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
Collaborators: name: Gmünder ErsatzKasse GEK
name: University of Cologne
First posted: 2008-02-26
Enrollment: 718
Sex: ALL
Minimum age (years): 43
Maximum age (years): 67
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Children in participating kindergartens

Exclusion Criteria:

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

Primary outcomes:
measure: Physical activity
timeFrame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
measure: motor skills
timeFrame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
Secondary outcomes:
measure: adiposity
timeFrame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
measure: blood pressure
timeFrame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
measure: accidents
timeFrame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
measure: infections
timeFrame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
measure: television viewing time
timeFrame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
Other outcomes:
Locations:
Study officials:
affiliation: University of Wuerzburg
name: Helge Hebestreit, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.