Division of Epidemiology and Public Health, School of Medicine, University of Nottingham, Nottingham, UK
The Nottingham Centre for Evidence-Based Healthcare: A Joanna Briggs Institute Centre of Excellence, University of Nottingham, Nottingham, UK.
BMJ Open. 2021 Oct 28;11(10):e052659. doi: 10.1136/bmjopen-2021-052659.
Children in China have low levels of physical activity. We developed a school-based behaviour change intervention to increase their physical activity levels. The study aimed to determine the feasibility of undertaking a cluster randomised controlled trial (RCT) in the future. This future cluster RCT will evaluate the effectiveness of the intervention.
Feasibility cluster non-RCT design.
Two public schools (one intervention and one control) in Yangzhou, China.
Children aged 10-12 years and their parents.
The 16-week school-based behaviour change intervention to increase physical activity levels consisted of three components (a) health education (physical education), (b) family involvement and (c) school environment support.
We estimated important parameters that are needed to design the future cluster RCT, such as SD of the primary outcome (ie, 7-day steps in children), intracluster correlation coefficient (ICC), recruitment of child-parent dyads, follow-up of children, completion of and time needed for data collection among children and intervention attendance.
Sixty-four children and their parents participated in the study (32 per study group). The SD of the primary outcome was 34 519 steps. The ICC was 0.03. The recruitment and follow-up rates were 100%. The completion of data collection was 100% (except for the 7-day steps at baseline-one child lost the step log in the intervention group and two children lost their pedometer in the control group). The time needed to complete the self-reported questionnaire by children was around 15 min per study group, and the measurement of their anthropometric parameters took around 40 min per study group. The intervention attendance was 100%.
Based on the promising recruitment, follow-up, completion of and time needed for data collection and intervention attendance, it would be feasible to undertake the future cluster RCT in China.
ChiCTR1900026865.
中国儿童的身体活动水平较低。我们开发了一项基于学校的行为改变干预措施，以提高他们的身体活动水平。本研究旨在确定未来进行集群随机对照试验（RCT）的可行性。这项未来的集群 RCT 将评估干预措施的有效性。
可行性集群非 RCT 设计。
中国扬州的两所公立学校（一所干预学校和一所对照学校）。
年龄在 10-12 岁的儿童及其家长。
为期 16 周的以学校为基础的行为改变干预措施旨在提高身体活动水平，包括三个组成部分：（a）健康教育（体育课），（b）家庭参与和（c）学校环境支持。
我们估计了未来集群 RCT 设计所需的重要参数，例如主要结局（即儿童的 7 天步数）的标准差、组内相关系数（ICC）、儿童-家长对子的招募、儿童随访、儿童数据收集的完成率和所需时间以及干预出勤率。
共有 64 名儿童及其家长参与了研究（每组 32 名）。主要结局的标准差为 34519 步。ICC 为 0.03。招募和随访率均为 100%。数据收集的完成率为 100%（除了干预组中的一名儿童丢失了步数记录，对照组中的两名儿童丢失了计步器）。儿童完成自我报告问卷所需的时间约为每组 15 分钟，测量他们的人体测量参数每组需要约 40 分钟。干预出勤率为 100%。
根据有希望的招募、随访、数据收集的完成率和所需时间以及干预出勤率，在中国进行未来的集群 RCT 是可行的。
ChiCTR1900026865。
