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

This study has been completed.
Sponsor:
Collaborator:
Dr. Freia De Bock, MD, Mannheim Institute of Public Health, Social and Preventive Medicine, Heidelberg University
Information provided by (Responsible Party):
Joachim E. Fischer, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01070251
First received: February 16, 2010
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Participatory parent-focused intervention
Behavioral: State-sponsored PA program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of a Multimodal Preference-based Parental Intervention on Preschoolers' Physical Activity Behaviour - a Cluster-randomized Trial

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Change in physical activity as measured by accelerometry and heart rate [ Time Frame: 0,6 and 12 months ] [ Designated as safety issue: No ]
    before intervention (0 months), 6 and 12 months later


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    before intervention (0 months), 6 and 12 months later


Other Outcome Measures:
  • Change in quality of life and subjective wellbeing [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
    before intervention (0 months), 6 and 12 months later


Enrollment: 826
Study Start Date: September 2008
Study Completion Date: April 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Existing state-sponsored PA program
standard children-focused gym lessons approach
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
Other Name: Standard physical activity lessons
Active Comparator: Participatory intervention plus state-sponsored PA program
Participatory parent-focused intervention over nine months in addition to state-sponsored PA program
Behavioral: Participatory parent-focused intervention
Parent workshops and internet-based support to establish healthy physical activity routines, added to existing state-sponsored PA program
Other Name: "Ene mene fit - Eltern machen mit!"
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
Other Name: Standard physical activity lessons

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

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070251

Locations
Germany
Mannheim Institute of Public Health, University of Heidelberg
Mannheim, Baden-Württemberg, Germany, 68167
Mannheim Institute of Public Health
Mannheim, Baden-Württemberg, Germany, 68167
Sponsors and Collaborators
Heidelberg University
Dr. Freia De Bock, MD, Mannheim Institute of Public Health, Social and Preventive Medicine, Heidelberg University
Investigators
Study Director: Joachim E Fischer, Prof MD MSc Mannheim Insitute of Public Health, Mannheim Medical Faculty, Heidelberg University
  More Information

Additional Information:
Publications:
Responsible Party: Joachim E. Fischer, Professor >Dr. med. MSc, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01070251     History of Changes
Other Study ID Numbers: CRTLasti_PA_kiga
Study First Received: February 16, 2010
Last Updated: July 31, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014