Yuan Yang, Jing Yuying, Li Jiyu, He Jieyi, Schwebel David C, Ning Peishan, Rao Zhenzhen, Li Li, Hu Guoqing
Department of Epidemiology and Health Statistics, Xiangya School of Public Health, Central South University, Public Health Bldg, 172 Tongzipo Road, Changsha, 410013, China, 86 15211051690.
Clinical Trials Center, The Affiliated Hospital of Guizhou Medical University, Guizhou, China.
JMIR Public Health Surveill. 2025 Jul 18;11:e76195. doi: 10.2196/76195.
Unintentional injury is a leading cause of childhood morbidity and mortality worldwide. In China, real-world implementation of child injury prevention efforts remains inadequate due to constrained workforce capacity and a lack of operational frameworks.
This study aims to assess the effectiveness of a mobile health (mHealth) intervention, the Intelligent Child Unintentional-Injury Reduction & Education (iCURE) project, embedded within China's National Basic Public Health Service Program. The intervention relies on a WeChat (Tencent) service account for caregivers and a web-based platform for health care providers to deliver standardized unintentional injury prevention strategies for young children. Key features of the program include interactive questions and answers, injury risk assessment with instant feedback, a tailored injury prevention knowledge disseminator, and regular reminders to caregivers.
A double-blind, 12-month follow-up, cluster randomized controlled trial will be implemented in Changsha, Hunan Province, China. Caregivers of children aged ≤5 years will be recruited. Randomization will be conducted at the street or town level. The control group will receive routine safety education, while the intervention group will receive both routine safety education and the iCURE mHealth intervention focused on unintentional injury prevention and delivered via WeChat. Data will be collected at baseline and every 3 months during the study period. The primary outcome is 12-month incidence of unintentional injuries among children, including minor injuries and as reported by caregivers. Secondary outcomes include children's injury risk level and caregiver supervision behaviors assessed using a standard questionnaire. Data analysis will be conducted using generalized linear mixed models with a Poisson link function and generalized estimating equations to assess the effectiveness of the iCURE intervention, following intention-to-treat principles. Sensitivity analyses will be conducted with per-protocol principles and excluding participants with missing primary outcomes.
As of May 2025, a total of 6701 participants have been successfully enrolled and baseline data were collected for all participants. Of those enrolled, 87.2% (5842/6,701) completed the first follow-up assessment.
This trial will examine the effectiveness of an intelligent mHealth intervention for child unintentional injury prevention building on China's National Basic Public Health Service Program. If successful, the iCURE intervention may provide a cost-effective strategy for child injury prevention in low- and middle-income countries.
意外伤害是全球儿童发病和死亡的主要原因。在中国，由于劳动力能力受限和缺乏操作框架，儿童伤害预防工作在现实世界中的实施仍然不足。
本研究旨在评估一项移动健康（mHealth）干预措施，即智能儿童意外伤害减少与教育（iCURE）项目，该项目嵌入中国国家基本公共卫生服务项目。该干预措施依赖于面向照顾者的微信（腾讯）服务账号和面向医疗保健提供者的基于网络的平台，为幼儿提供标准化的意外伤害预防策略。该项目的关键特性包括互动问答、即时反馈的伤害风险评估、量身定制的伤害预防知识传播工具，以及定期向照顾者发送提醒。
将在中国湖南省长沙市开展一项双盲、为期12个月的随访、整群随机对照试验。将招募5岁及以下儿童的照顾者。随机分组将在街道或乡镇层面进行。对照组将接受常规安全教育，而干预组将同时接受常规安全教育和通过微信提供的侧重于意外伤害预防的iCURE移动健康干预措施。在研究期间，将在基线时以及每3个月收集一次数据。主要结局是儿童意外伤害的12个月发病率，包括轻伤以及照顾者报告的伤害。次要结局包括使用标准问卷评估的儿童伤害风险水平和照顾者监督行为。将使用具有泊松链接函数的广义线性混合模型和广义估计方程进行数据分析，以按照意向性分析原则评估iCURE干预措施的有效性。将按照符合方案原则并排除主要结局缺失的参与者进行敏感性分析。
截至2025年5月，共成功招募了6701名参与者，并收集了所有参与者的基线数据。在已招募的参与者中，87.2%（5842/6701）完成了首次随访评估。
本试验将检验基于中国国家基本公共卫生服务项目的智能移动健康干预措施对预防儿童意外伤害的有效性。如果成功，iCURE干预措施可能为低收入和中等收入国家的儿童伤害预防提供一种具有成本效益的策略。
