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多中心整群随机临床试验方案:一项促进儿童身体活动和健康的运动技能干预措施,即 CHAMP 课后项目研究。

Protocol for a multicenter-cluster randomized clinical trial of a motor skills intervention to promote physical activity and health in children: the CHAMP afterschool program study.

机构信息

School of Kinesiology, University of Michigan, Ann Arbor, MI, 48109, USA.

Department of Kinesiology, College of Education, Michigan State University, East Lansing, MI, 48824, USA.

出版信息

BMC Public Health. 2022 Aug 13;22(1):1544. doi: 10.1186/s12889-022-13849-8.

DOI:10.1186/s12889-022-13849-8
PMID:35964114
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9375271/
Abstract

BACKGROUND

Promoting health-enhancing and sustainable physical activity levels across childhood and adolescence contribute to positive health outcomes as an adult. This study will aim to: a) examine the immediate (pre- to post-intervention) and sustained (1-year post-intervention follow-up) effects of the Children's Health Activity Motor Program-Afterschool Program (CHAMP-ASP) on physical activity, motor competence, and perceived motor competence relative to the comparison ASP, b) examine the immediate and sustained effects of CHAMP-ASP on secondary health outcomes, specifically health-related physical fitness (i.e., cardiorespiratory fitness, muscular strength, percent body fat) and weight status compared to children in the comparison ASP, and c) determine if perceived motor competence mediates the effect of CHAMP-ASP on moderate-to-vigorous physical activity.

METHODS

This multicenter cluster randomized trial will be implemented by ASP staff and will be conducted in ASPs located in two city-based cohorts: East Lansing/Lansing and Ann Arbor/Ypsilanti, Michigan. Children (N = 264) who are K-2 graders will participate 35 min/day X 3 days/week for 19 weeks (1995 min) in their afterschool movement program (i.e., CHAMP-ASP vs. comparison). The research team will train ASP staff to implement the program, which will be delivered within the existing ASP offering. Measures of physical activity (accelerometer), motor competence (process and product measures of fundamental motor skills), health-related fitness, perceived motor competence, and anthropometry will be collected pre-, immediately post-, and one-year post-intervention. Random-effects models will be used to assess the clustered longitudinal effect of the intervention on outcome measures.

DISCUSSION

The long-term goal is to provide a sustainable, ecologically-relevant, and evidence-based program during the early elementary years that can be delivered by ASP staff, is health-enhancing, and increases physical activity in children. Findings hold the potential to help shape public health and educational policies and interventions that support healthy development and active living during the early years.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier NCT05342701 .

ETHICS AND DISSEMINATION

Ethical approval was obtained through the Health Sciences and Behavioral Sciences IRB, University of Michigan (HUM00208311). The CHAMP-ASP study is funded by the National Institutes of Health. Findings will be disseminated via print, online media, dissemination events, and practitioner and/or research journals.

摘要

背景

促进儿童和青少年时期促进健康和可持续的身体活动水平,有助于成年后获得积极的健康结果。本研究旨在:a)检查儿童健康活动运动计划-课后计划(CHAMP-ASP)对身体活动、运动能力和感知运动能力的即时(干预前至干预后)和持续(干预后 1 年随访)效果,相对于比较 ASP,b)检查 CHAMP-ASP 对次要健康结果的即时和持续影响,特别是与比较 ASP 中的儿童相比,与健康相关的身体素质(即心肺健康、肌肉力量、体脂百分比)和体重状况,c)确定感知运动能力是否介导 CHAMP-ASP 对中高强度身体活动的影响。

方法

这项多中心集群随机试验将由 ASP 工作人员实施,并将在位于密歇根州东兰辛/兰辛和安娜堡/伊普西兰蒂的两个城市队列中的 ASP 中进行。K-2 年级的儿童(N=264)将参加他们的课后运动计划(即 CHAMP-ASP 与比较),每天 35 分钟 X 3 天/周,共 19 周(1995 分钟)。研究团队将培训 ASP 工作人员实施该计划,该计划将在现有的 ASP 提供中实施。在干预前、干预后立即和干预后 1 年收集身体活动(加速度计)、运动能力(基本运动技能的过程和产品测量)、与健康相关的健康、感知运动能力和人体测量数据。随机效应模型将用于评估干预对结果测量的聚类纵向影响。

讨论

长期目标是在小学早期提供一种可持续、与生态相关且基于证据的计划,该计划可以由 ASP 工作人员提供,有益于健康,并增加儿童的身体活动。研究结果有可能有助于制定公共卫生和教育政策和干预措施,以支持早期的健康发展和积极生活。

试验注册

ClinicalTrials.gov 标识符 NCT05342701。

伦理和传播

密歇根大学健康科学和行为科学 IRB 通过了伦理批准(HUM00208311)。CHAMP-ASP 研究由美国国立卫生研究院资助。研究结果将通过印刷、在线媒体、传播活动以及从业者和/或研究期刊进行传播。

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