NCT04511585

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

1.8 years

First QC Date

August 28, 2017

Last Update Submit

August 11, 2020

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

GLMC experimental arm

EXPERIMENTAL

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

the control arm

NO INTERVENTION

the control arm that do not receive any intervention

Interventions

Great Live and Move ChallengeBEHAVIORAL

Physical activity program for children

GLMC experimental arm

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut régional di Cancer de Montpellier (ICM)

Montpellier, 34298, France

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Florence cousson gelie

    Epidaure, prevention department of ICM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: a 24-month (6 weeks each year) multilevel and TPB-based program aiming to promote PA practice
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 13, 2020

Study Start

March 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

August 13, 2020

Record last verified: 2020-08

Locations

FR(1)