Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04511585
Status:
COMPLETED
Last Update Posted:
2020-08-13
First Post:
2017-08-28
Brief Title:
The Great Live and Move Challenge Among Children Aged 7-11 Years
Sponsor:
Institut du Cancer de Montpellier - Val dAurelle
Organization:
Institut du Cancer de Montpellier - Val dAurelle
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 minutesday 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 35 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 ie intentions attitudes subjective norms perceived behavioral control and other psychosocial variables eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None