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A Participatory Parental Intervention Promoting Physical Activity in Preschools

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ClinicalTrials.gov Identifier: NCT00987532
Recruitment Status : Unknown
Verified September 2009 by Universitätsmedizin Mannheim.
Recruitment status was:  Active, not recruiting
First Posted : October 1, 2009
Last Update Posted : October 1, 2009
Sponsor:
Collaborator:
Landesstiftung Baden-Württemberg
Information provided by:
Universitätsmedizin Mannheim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Physical Activity Behavioral: parent-focused intervention Behavioral: twice weekly gym lessons Not Applicable

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  (Clinical Trial)
Actual Enrollment : 1047 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : September 2008
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Behavioral: parent-focused intervention
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 Name: Ene mene fit - Eltern machen mit
Behavioral: twice weekly gym lessons
twice weekly one-hour gym lessons delivered by a specially trained external physical education teacher over 6 months
Other Name: child-centered physical activity intervention
Active Comparator: gym lessons only
Twice weekly one-hour gym lessons delivered by a specially trained external physical education teacher over 6 months
Behavioral: twice weekly gym lessons
twice weekly one-hour gym lessons delivered by a specially trained external physical education teacher over 6 months
Other Name: child-centered physical activity intervention



Primary Outcome Measures :
  1. Absolute change in mean accelerometry counts over 6 days [ Time Frame: baseline, end of intervention, six months after end of intervention ]

Secondary Outcome Measures :
  1. Body Mass Index [ Time Frame: baseline, end of intervention, six months after end of intervention ]


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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 3-6 years

Exclusion Criteria:

  • severe atopic dermatitis,
  • serious acute infectious diseases,
  • physical malformations, and
  • severe physical disabilities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987532


Locations
Germany
Mannheim Institute of Public Health, Medical Faculty Mannheim, Heidelberg University
Mannheim, Baden-Württemberg, Germany, 68167
Sponsors and Collaborators
Universitätsmedizin Mannheim
Landesstiftung Baden-Württemberg
Investigators
Principal Investigator: Joachim E. Fischer, MD, M.Sc. Mannheim Institute of Public Health, Medical Faculty Mannheim, Heidelberg University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joachim Fischer, Prof. Dr. med. M.Sc. MD, Mannheim Institute of Public Health, Medical Faculty Mannheim, University Medicine Mannheim
ClinicalTrials.gov Identifier: NCT00987532     History of Changes
Other Study ID Numbers: MIPH_KITA2008
First Posted: October 1, 2009    Key Record Dates
Last Update Posted: October 1, 2009
Last Verified: September 2009

Keywords provided by Universitätsmedizin Mannheim:
preschool
participatory intervention
cluster-randomization
children
obesity prevention