Clinical trial NCT01070251: Effects of a Multimodal Preference-based Parental Intervention on Preschoolers' Physical Activity Behaviour - a Cluster-randomized Trial
Official title: Effects of a Multimodal Preference-based Parental Intervention on Preschoolers' Physical Activity Behaviour - a Cluster-randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2010-02-17
Enrollment: 826
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in physical activity as measured by accelerometry and heart rate
timeFrame: 0,6 and 12 months
Secondary outcomes:
measure: 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.
timeFrame: 0, 6 and 12 months
Other outcomes:
measure: Change in quality of life and subjective wellbeing
timeFrame: 0, 6 and 12 months
Locations:
city: Mannheim
country: Germany
facility: Mannheim Institute of Public Health, University of Heidelberg
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: Mannheim Institute of Public Health
state: Baden-Württemberg
Study officials:
affiliation: Mannheim Insitute of Public Health, Mannheim Medical Faculty, Heidelberg University
name: Joachim E Fischer, Prof MD MSc
role: STUDY_DIRECTOR
References:
citation: Reilly JJ, Kelly L, Montgomery C, Williamson A, Fisher A, McColl JH, Lo Conte R, Paton JY, Grant S. Physical activity to prevent obesity in young children: cluster randomised controlled trial. BMJ. 2006 Nov 18;333(7577):1041. doi: 10.1136/bmj.38979.623773.55. Epub 2006 Oct 6.
citation: Taylor RW, Mcauley KA, Williams SM, Barbezat W, Nielsen G, Mann JI. Reducing weight gain in children through enhancing physical activity and nutrition: the APPLE project. Int J Pediatr Obes. 2006;1(3):146-52. doi: 10.1080/17477160600881247.