NCT01070251

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
826

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

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
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

2 years

First QC Date

February 16, 2010

Last Update Submit

July 31, 2012

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in physical activity as measured by accelerometry and heart rate

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

    0,6 and 12 months

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.

    0, 6 and 12 months

Other Outcomes (1)

  • Change in quality of life and subjective wellbeing

    0, 6 and 12 months

Study Arms (2)

Existing state-sponsored PA program

ACTIVE COMPARATOR

standard children-focused gym lessons approach

Behavioral: State-sponsored PA program

Participatory intervention plus state-sponsored PA program

ACTIVE COMPARATOR

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

Behavioral: Participatory parent-focused interventionBehavioral: State-sponsored PA program

Interventions

Participatory parent-focused interventionBEHAVIORAL

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

Also known as: "Ene mene fit - Eltern machen mit!"
Participatory intervention plus state-sponsored PA program
State-sponsored PA programBEHAVIORAL

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

Also known as: Standard physical activity lessons
Existing state-sponsored PA programParticipatory intervention plus state-sponsored PA program

Eligibility Criteria

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

You may qualify if:

  • Healthy children
  • Participation in the standard physical activity lesson twice weekly

You may not qualify if:

  • Age under 3 years or above 6 years
  • Serious atopic dermatitis
  • Genetic conditions
  • Metabolic diseases
  • Acute infectious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mannheim Institute of Public Health, University of Heidelberg

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Mannheim Institute of Public Health

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Related Publications (2)

  • 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.

    PMID: 17028105BACKGROUND

  • 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.

    PMID: 17899632BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Joachim E Fischer, Prof MD MSc

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

    STUDY DIRECTOR

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
Professor >Dr. med. MSc

Study Record Dates

First Submitted

February 16, 2010

First Posted

February 17, 2010

Study Start

September 1, 2008

Primary Completion

September 1, 2010

Study Completion

April 1, 2011

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

DE(2)