Clinical Trials Directory

Trials / Completed

CompletedNCT04511585

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
5,000 (actual)
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
Sex
All
Age
7 Years – 11 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALGreat Live and Move ChallengePhysical activity program for children

Timeline

Start date
2016-03-01
Primary completion
2017-12-01
Completion
2018-12-01
First posted
2020-08-13
Last updated
2020-08-13

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04511585. Inclusion in this directory is not an endorsement.