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

NCT ID: NCT01070251

Last Updated: 2012-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 826 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-04-30

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Existing state-sponsored PA program

standard children-focused gym lessons approach

Group Type: ACTIVE_COMPARATOR

State-sponsored PA program

Intervention Type: BEHAVIORAL

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

Participatory intervention plus state-sponsored PA program

Participatory parent-focused intervention over nine months in addition to state-sponsored PA program

Group Type: ACTIVE_COMPARATOR

Participatory parent-focused intervention

Intervention Type: BEHAVIORAL

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

State-sponsored PA program

Intervention Type: BEHAVIORAL

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

Interventions

Participatory parent-focused intervention

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

Intervention Type: BEHAVIORAL

State-sponsored PA program

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

Intervention Type: BEHAVIORAL

Other Intervention Names

"Ene mene fit - Eltern machen mit!"; Standard physical activity lessons

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Joachim E. Fischer

Professor >Dr. med. MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joachim E Fischer, Prof MD MSc

Role: STUDY_DIRECTOR

Mannheim Insitute of Public Health, Mannheim Medical Faculty, Heidelberg University

Locations

Mannheim Institute of Public Health, University of Heidelberg

Mannheim, Baden-Wurttemberg, Germany

Mannheim Institute of Public Health

Mannheim, Baden-Wurttemberg, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 17028105 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17899632 (View on PubMed)

Other Identifiers

CRTLasti_PA_kiga

Identifier Type: -

Identifier Source: org_study_id