Effects of a Multimodal Preference-based Parental Intervention on Preschoolers' Physical Activity Behaviour - a Cluster-randomized Trial

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT01070251
• Lead Sponsor: Heidelberg University

Brief Summary

This study investigates whether a preschool-based physical activity intervention involving parents as active agents of behavioral change affects objectively measured physical activity in preschool children.

Detailed Description

In the last 25 years, obesity in children has increased dramatically in Germany (Lampert et al. 2007, Stolzenberg et al., 2007) and other western societies. Lack of physical activity (PA) is one important factor contributing to obesity development. However, healthy behaviors are established early in life (adiposity rebound: Reilly 2008), which underlines the importance of early interventions. Preschools therefore might be an ideal setting for interventions to promote physical activity. While previous preschool interventions were directly aimed at the children's physical activity behaviors (e.g. promoting activity by sports lessons), parents as influential caregivers were mainly involved in educational ways and by information (e.g. newsletters, physical activity homework).

The current intervention takes a participatory approach to involve parents as active agents of behavioral change. The study aim is to evaluate the effects of the participatory preference-based parental intervention on preschoolers' objectively measured physical activity behaviour and Body Mass Index (BMI). The intervention can easily be added as a parent module to existing children-focused physical activity programmes.

In several workshops, parents are presented a set of possible project ideas for improving everyday physical activity in the preschools. After forming teams, they either select project ideas from the preexisting menu or develop ideas de novo and then implement them into the local preschool environment.

The intervention is implemented in the frame of an existing state-sponsored physical activity (PA) program offering twice weekly sports lessons by external gym trainers to preschoolers over a period of 6 months. Preschools in the control arm get the state-sponsored PA program only. Preschools in the intervention arm get the participatory parent-focused PA intervention in addition to the existing state-sponsored PA program.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Primary Completion: 2010-09
• Study Completion: 2011-04
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-31
• Last Update Posted: 2012-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 826

Inclusion Criteria

• Healthy children
• Participation in the standard physical activity lesson twice weekly

Exclusion Criteria

• Age under 3 years or above 6 years
• Serious atopic dermatitis
• Genetic conditions
• Metabolic diseases
• Acute infectious diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in physical activity as measured by accelerometry and heart rate	0,6 and 12 months	before intervention (0 months), 6 and 12 months later

Secondary Outcome Measures

Name	Time	Method
Change in Body Mass Index, percent fat mass (based on skin folds), waist-to-height ratio and waist circumference Change in blood pressure, sympathetic/parasympathetic tone. Sleep quantity by accelerometry.	0, 6 and 12 months	before intervention (0 months), 6 and 12 months later

Trial Locations

Locations (2)

Mannheim Institute of Public Health, University of Heidelberg; 🇩🇪 Mannheim, Baden-Württemberg, Germany

Mannheim Institute of Public Health; 🇩🇪 Mannheim, Baden-Württemberg, Germany