NCT00987532

Brief Summary

The aim of this study is to test whether a parent-focused participatory intervention in addition to gym lessons can enhance preschoolers physical activity compared to gym lessons alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,047

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

September 30, 2009

Last Update Submit

May 9, 2023

Conditions

ObesityPhysical Activity

Keywords

preschoolparticipatory interventioncluster-randomizationchildrenobesity prevention

Outcome Measures

Primary Outcomes (1)

  • Absolute change in mean accelerometry counts over 6 days

    baseline, end of intervention, six months after end of intervention

Secondary Outcomes (1)

  • Body Mass Index

    baseline, end of intervention, six months after end of intervention

Study Arms (2)

parent intervention plus gym lessons

EXPERIMENTAL

Parent-focused participatory preschool intervention in addition to twice weekly gym lessons over 6 months. The participatory intervention includes parents, teachers and children.

Behavioral: parent-focused interventionBehavioral: twice weekly gym lessons

gym lessons only

ACTIVE COMPARATOR

Twice weekly one-hour gym lessons delivered by a specially trained external physical education teacher over 6 months

Behavioral: twice weekly gym lessons

Interventions

parent-focused interventionBEHAVIORAL

The core of the parent-focused intervention is a menu of 15 easy to realize project ideas to promote the everyday physical activity of children and families. The 15 ideas are presented to the parents and teachers via a webpage, a printed book and a film. During a face-to-face meeting, parents and teachers are guided into discussions of their own preschool environment's and community's physical activity shortcomings and encouraged to generate their own ideas of how to enhance the physical activity of their families and preschools. Over the course of three structured follow-up meetings, parents and teachers are instructed to choose maximally 3 to 4 ideas from either the menu or the network's own ideas, and then are empowered to realize and implement them together.

Also known as: Ene mene fit - Eltern machen mit
parent intervention plus gym lessons
twice weekly gym lessonsBEHAVIORAL

twice weekly one-hour gym lessons delivered by a specially trained external physical education teacher over 6 months

Also known as: child-centered physical activity intervention
gym lessons onlyparent intervention plus gym lessons

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • age 3-6 years

You may not qualify if:

  • severe atopic dermatitis,
  • serious acute infectious diseases,
  • physical malformations, and
  • severe physical disabilities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Related Publications (2)

  • De Bock F, Genser B, Raat H, Fischer JE, Renz-Polster H. A participatory physical activity intervention in preschools: a cluster randomized controlled trial. Am J Prev Med. 2013 Jul;45(1):64-74. doi: 10.1016/j.amepre.2013.01.032.

    PMID: 23790990DERIVED

  • De Bock F, Fischer JE, Hoffmann K, Renz-Polster H. A participatory parent-focused intervention promoting physical activity in preschools: design of a cluster-randomized trial. BMC Public Health. 2010 Jan 31;10:49. doi: 10.1186/1471-2458-10-49.

    PMID: 20113522DERIVED

Related Links

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Joachim E. Fischer, MD, M.Sc.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Mannheim Institute of Public Health

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 1, 2009

Study Start

September 1, 2008

Primary Completion

September 1, 2010

Study Completion

March 1, 2011

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations

DE(1)