NCT00967460

Brief Summary

The purpose of the study is to evaluate the effect of a project promoting unstructured spontaneous physical activity (PA) through an adaptation of the built environment and the provision of a supportive social environment of childcare centers on motor skills, physical activity, desire to move around, body mass index (BMI), quality of life and PA and behavior of the family.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,764

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

January 28, 2011

Status Verified

August 1, 2009

Enrollment Period

1.7 years

First QC Date

August 26, 2009

Last Update Submit

January 27, 2011

Conditions

Keywords

Childhood obesityChildrenInactivityPhysical activityMotor skillsMotor fitnessQuality of lifeNutritionFamily

Outcome Measures

Primary Outcomes (1)

  • Motor skills

    1 school year

Secondary Outcomes (5)

  • Physical activity

    1 school year

  • Enjoyment of physical activity

    1 school year

  • BMI

    1 school year

  • Quality of life

    1 school year

  • Physical activity and behavior of the family

    1 school year

Study Arms (2)

Control group: No intervention

NO INTERVENTION

No intervention, regular childcare program

Intervention group

EXPERIMENTAL

Promoting unstructured spontaneous PA through an adaptation of the built environment and the provision of a supportive social environment

Behavioral: Lifestyle intervention

Interventions

Promoting unstructured spontaneous physical in childcare through an adaptation of the built environment and the provision of a supportive social environment

Intervention group

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children in selected childcare centers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ligues de la santé

Lausanne, Switzerland

Location

University of Lausanne Hospitals

Lausanne, Switzerland

Location

University of Lausanne

Lausanne, Switzerland

Location

Related Publications (1)

  • Bonvin A, Barral J, Kakebeeke TH, Kriemler S, Longchamp A, Schindler C, Marques-Vidal P, Puder JJ. Effect of a governmentally-led physical activity program on motor skills in young children attending child care centers: a cluster randomized controlled trial. Int J Behav Nutr Phys Act. 2013 Jul 8;10:90. doi: 10.1186/1479-5868-10-90.

MeSH Terms

Conditions

ObesitySedentary BehaviorPediatric ObesityMotor Activity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 26, 2009

First Posted

August 27, 2009

Study Start

January 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

January 28, 2011

Record last verified: 2009-08

Locations