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NCT Number: NCT01070251

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mannheim Institute of Public Health, Mannheim, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Participatory parent-focused intervention

Behavioral

Parent workshops and internet-based support to establish healthy physical activity routines, added to existing state-sponsored PA program

Other names: "Ene mene fit - Eltern machen mit!"

State-sponsored PA program

Behavioral

Preschool children receive twice a week 60 minutes of physical activity lessons over 6 months by an external gym trainer

Other names: Standard physical activity lessons

Primary outcomes

  1. Change in physical activity as measured by accelerometry and heart rate

    Time frame: 0,6 and 12 months

    before intervention (0 months), 6 and 12 months later

Secondary outcomes

  1. 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.

    Time frame: 0, 6 and 12 months

    before intervention (0 months), 6 and 12 months later

Other outcomes

  1. Change in quality of life and subjective wellbeing

    Time frame: 0, 6 and 12 months

    before intervention (0 months), 6 and 12 months later

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Feb 17, 2010
Registry last updated
Aug 1, 2012

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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