NCT00623844

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
718

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2007

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

March 31, 2015

Status Verified

December 1, 2014

Enrollment Period

1.5 years

First QC Date

February 14, 2008

Last Update Submit

March 30, 2015

Conditions

Child, Preschool

Keywords

PreventionPhysical activityObesityMotor skillsKindergarten

Outcome Measures

Primary Outcomes (2)

  • Physical activity

    Accelerometry over 7 days

    baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention

  • motor skills

    Composite score of several motor tasks

    baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention

Secondary Outcomes (5)

  • adiposity

    baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention

  • blood pressure

    baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention

  • accidents

    baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention

  • infections

    baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention

  • television viewing time

    baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: physical activity

Control

NO INTERVENTION

Keep usual activities in kindergarten

Interventions

physical activityBEHAVIORAL

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

Eligibility Criteria

Age43 Months - 67 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children in participating kindergartens

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20624316DERIVED

MeSH Terms

Conditions

Motor ActivityObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Helge Hebestreit, MD, PhD

    University of Wuerzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 26, 2008

Study Start

May 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

March 31, 2015

Record last verified: 2014-12