The "Great Live and Move Challenge" Among Children Aged 7-11 Years

Physical Activity Clinical Trial

Official title:

The "Great Live and Move Challenge": a Program to Promote Physical Activity Among Children Aged 7-11 Years. Design and Implementation of a Cluster-randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04511585
• Other study ID #: EPIDAURE- 2017/01
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2020
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Great Live and Move Challenge (GLMC) study is a 2-year cluster-randomized controlled trial designed to evaluate a multilevel and theory-based intervention to promote PA practice in children aged 7-11 years from French primary schools.

Description:

Recent population-based surveys have reported that a large majority of children were not active enough to meet the physical activity (PA) international guidelines in France, Europe and in the US. Therefore, there is a need to find efficient programs to improve PA habits in children from early age. The Great Live and Move Challenge (GLMC) study is a 2-year cluster-randomized controlled trial designed to evaluate a multilevel and theory-based intervention to promote PA practice in children aged 7-11 years from French primary schools. The aim of this paper is to describe the GLMC study protocol. The primary hypothesis is that the GLMC intervention will increase by 15% the proportion of children meeting the World Health Organization recommendations of 60 minutes/day of moderate to vigorous PA. Study recruitment goal is 5000 children . The GLMC is implemented on children and their parents and involves multiple local grass-roots partners, such as school teachers and municipal officials, as well as policy stakeholders. The Theory of Planned Behavior (TPB) constitutes the foundations of the intervention conception. The total duration of the intervention is 3.5 months each year, for two years. Children and parents are evaluated at pre- and post-intervention every year regarding PA practice (self-reported and objectively measured in a subsample of 400 children), TPB variables (i.e., intentions, attitudes, subjective norms, perceived behavioral control) and other psychosocial variables (e.g., perceptions of active opportunities). This study will evaluate the effectiveness of a multilevel and theory-based primary school PA program and potentially provide valuable information for schools and public health policers looking for innovative PA programs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

Inclusion Criteria:

• All the children (and their parents) schooled in a primary school (year 3 or year 4) from Hérault, Gard, and Aude French departments

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Great Live and Move Challenge
Physical activity program for children

Locations

Country	Name	City	State
France	Institut régional di Cancer de Montpellier (ICM)	Montpellier

Sponsors (4)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle	Academic resource center of herault, Laboratoire EPSYLON, University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity practice in hours per week in children is self-recorded	physical activity practice in hours per week in children is self-recorded using an adapted version of the self-administered Physical Activity Questionnaire for Children (PAQ-C)	up to 3.5 years