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Completed

NCT Number: NCT00623844

Prevention Through Activity 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.

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Key information

Conditions

Child, Preschool Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

43 month–67 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children in participating kindergartens

Exclusion criteria

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

Treatment and study plan

Physical activity

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

Primary outcomes

  1. Physical activity

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

    Accelerometry over 7 days

  2. 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

Secondary outcomes

  1. adiposity

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

    BMI, skinfolds

  2. blood pressure

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

  3. accidents

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

  4. infections

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

  5. television viewing time

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

Sponsors and collaborators

Lead sponsor

University of Wuerzburg

Other

Collaborators

  • Gmünder ErsatzKasse GEK
  • University of Cologne

Registry information

Official study title

Prevention Through Acitivity in Kindergarten Trial

Acronym: PAKT

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 26, 2008
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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