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

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.

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity
• Intervention / Treatment: Behavioral: Great Live and Move Challenge

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 5000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34298
    • Institut régional di Cancer de Montpellier (ICM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GLMC experimental arm; GLMC experimental arm receiving a 24-month (6 weeks each year) multilevel and TPB-based program aiming to promote PA practice	Behavioral: Great Live and Move Challenge; Physical activity program for children
NO_INTERVENTION: the control arm; the control arm that do not receive any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Collaborators: University Hospital, Clermont-Ferrand; Laboratoire EPSYLON; Academic resource center of herault
• Investigators: Principal Investigator: Florence cousson gelie, Epidaure, prevention department of ICM

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2016
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (ACTUAL): August 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: EPIDAURE- 2017/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No