- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00987532
A Participatory Parental Intervention Promoting Physical Activity in Preschools
May 9, 2023 updated by: Joachim E. Fischer, MD MSc, Universitätsmedizin Mannheim
The aim of this study is to test whether a parent-focused participatory intervention in addition to gym lessons can enhance preschoolers physical activity compared to gym lessons alone.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Over the last 20 years, physical activity (PA) in children has rapidly decreased in both developed and developing nations.
More effective interventions to prevent inactivity in childhood thus are urgently needed.
The preschool years, including the adiposity rebound period, might represent a good window of opportunity.
Study literature suggests that targeting parents is crucial for lasting changes in young childrens' behavior.
However, it is not known which methods are effective for involving parents in physical activity promotion.
Consistent with experience from community-based participatory research, encouraging parents to participate the intervention in terms of content and structure might lead to higher intervention effectivity and sustainability.
In our study, we therefore "enriched" a child-centered physical activity intervention in preschools (twice weekly gym lessons over 6 months) with a parent-focused participatory community intervention component.
Study Type
Interventional
Enrollment (Actual)
1047
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Baden-Württemberg
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Mannheim, Baden-Württemberg, Germany, 68167
- Mannheim Institute of Public Health, Medical Faculty Mannheim, Heidelberg University
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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 6 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- age 3-6 years
Exclusion Criteria:
- severe atopic dermatitis,
- serious acute infectious diseases,
- physical malformations, and
- severe physical disabilities.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: parent intervention plus gym lessons
Parent-focused participatory preschool intervention in addition to twice weekly gym lessons over 6 months.
The participatory intervention includes parents, teachers and children.
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The core of the parent-focused intervention is a menu of 15 easy to realize project ideas to promote the everyday physical activity of children and families.
The 15 ideas are presented to the parents and teachers via a webpage, a printed book and a film.
During a face-to-face meeting, parents and teachers are guided into discussions of their own preschool environment's and community's physical activity shortcomings and encouraged to generate their own ideas of how to enhance the physical activity of their families and preschools.
Over the course of three structured follow-up meetings, parents and teachers are instructed to choose maximally 3 to 4 ideas from either the menu or the network's own ideas, and then are empowered to realize and implement them together.
Other Names:
twice weekly one-hour gym lessons delivered by a specially trained external physical education teacher over 6 months
Other Names:
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Active Comparator: gym lessons only
Twice weekly one-hour gym lessons delivered by a specially trained external physical education teacher over 6 months
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twice weekly one-hour gym lessons delivered by a specially trained external physical education teacher over 6 months
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Absolute change in mean accelerometry counts over 6 days
Time Frame: baseline, end of intervention, six months after end of intervention
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baseline, end of intervention, six months after end of intervention
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Body Mass Index
Time Frame: baseline, end of intervention, six months after end of intervention
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baseline, end of intervention, six months after end of intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joachim E. Fischer, MD, M.Sc., Mannheim Institute of Public Health, Medical Faculty Mannheim, Heidelberg University
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
- De Bock F, Genser B, Raat H, Fischer JE, Renz-Polster H. A participatory physical activity intervention in preschools: a cluster randomized controlled trial. Am J Prev Med. 2013 Jul;45(1):64-74. doi: 10.1016/j.amepre.2013.01.032.
- De Bock F, Fischer JE, Hoffmann K, Renz-Polster H. A participatory parent-focused intervention promoting physical activity in preschools: design of a cluster-randomized trial. BMC Public Health. 2010 Jan 31;10:49. doi: 10.1186/1471-2458-10-49. Erratum In: BMC Public Health. 2012;12:355.
Helpful Links
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
September 1, 2008
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
September 30, 2009
First Submitted That Met QC Criteria
September 30, 2009
First Posted (Estimate)
October 1, 2009
Study Record Updates
Last Update Posted (Estimate)
May 11, 2023
Last Update Submitted That Met QC Criteria
May 9, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIPH_KITA2008
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