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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Participatory parent-focused intervention
* Behavioral: State-sponsored PA program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Existing state-sponsored PA program<br>standard children-focused gym lessons approach | Behavioral: State-sponsored PA program<br>* Preschool children receive twice a week 60 minutes of physical activity lessons over 6 months by an external gym trainer<br>* Other names: Standard physical activity lessons;|
| Active Comparator: Participatory intervention plus state-sponsored PA program<br>Participatory parent-focused intervention over nine months in addition to state-sponsored PA program | Behavioral: Participatory parent-focused intervention<br>* Parent workshops and internet-based support to establish healthy physical activity routines, added to existing state-sponsored PA program<br>* Other names: Ene mene fit - Eltern machen mit!;Behavioral: State-sponsored PA program<br>* Preschool children receive twice a week 60 minutes of physical activity lessons over 6 months by an external gym trainer<br>* Other names: Standard physical activity lessons;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity as measured by accelerometry and heart rate | before intervention (0 months), 6 and 12 months later | 0,6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | before intervention (0 months), 6 and 12 months later | 0, 6 and 12 months |