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

Institut du Cancer de Montpellier - Val d'Aurelle

Status: Completed

Conditions: Physical Activity

Treatments: Behavioral: Great Live and Move Challenge

Study type: Interventional

Funder types: Other

Identifiers

NCT04511585

EPIDAURE- 2017/01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 patients

Sex: All

Ages: 7 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5,000 participants in 2 patient groups

GLMC experimental arm

Experimental group

Description:

GLMC experimental arm receiving a 24-month (6 weeks each year) multilevel and TPB-based program aiming to promote PA practice

Treatment:

Behavioral: Great Live and Move Challenge

the control arm

No Intervention group

Description:

the control arm that do not receive any intervention