Prevention Through Activity in Kindergarten Trial (PAKT)

March 30, 2015 updated by: Helge Hebestreit, University of Wuerzburg

Prevention Through Acitivity in Kindergarten Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

718

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children in participating kindergartens

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Physical activity intervention: structured daily 30-min activity classes at preschool, activity homeworks, parent and teacher education
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: Control
Keep usual activities in kindergarten

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
Accelerometry over 7 days
baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
motor skills
Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
Composite score of several motor tasks
baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adiposity
Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
BMI, skinfolds
baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
blood pressure
Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
accidents
Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
infections
Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
television viewing time
Time Frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wuerzburg

Collaborators

University of Cologne
Gmünder ErsatzKasse GEK

Investigators

  • Principal Investigator: Helge Hebestreit, MD, PhD, University of Wuerzburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 25, 2008

First Posted (Estimate)

February 26, 2008

Study Record Updates

Last Update Posted (Estimate)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BMBF 01EL0606

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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