跳至主要内容
临床试验/NCT04511585
NCT04511585已完成不适用

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.

Institut du Cancer de Montpellier - Val d'Aurelle1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,000
试验地点
1
主要终点
Physical activity practice in hours per week in children is self-recorded

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

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

干预措施: Great Live and Move Challenge (Behavioral)

the control arm

No Intervention

the control arm that do not receive any intervention

结局指标

主要结局

Physical activity practice in hours per week in children is self-recorded

时间窗: up to 3.5 years

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)

次要结局

未报告次要终点

研究者

发起方
Institut du Cancer de Montpellier - Val d'Aurelle
申办方类型
Other
责任方
Sponsor

研究点 (1)

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