Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.
Georgetown Lombardi Cancer Center, Washington, DC, United States of America.
Contemp Clin Trials. 2022 Nov;122:106961. doi: 10.1016/j.cct.2022.106961. Epub 2022 Oct 10.
Promoting physical activity soon after treatment for childhood cancer may benefit health because sedentary lifestyle during curative therapy may perpetuate physical and emotional complications. The primary goals of this study are to evaluate the effects of a 6-month web-based, rewards-based physical activity intervention on fitness, biomarkers of cardiometabolic health, inflammation, adipokine status, quality of life and school attendance, and determine if effect of intervention on markers of cardiometabolic health is mediated by changes in fitness. The primary outcome of interest is fitness (physiological cost index, six-minute walk test) measured at end of intervention.
This ongoing study is a two-arm, prospective, randomized design with accrual goals of 192 children for intervention and control groups. Children ≥8 years and < 16 years of age, not meeting recommended levels of physical activity, who completed therapy within the past 12 months are eligible. Both groups receive: 1) educational materials encouraging physical activity, 2) activity monitor, 3) access to web-based interface designed to motivate physical activity, 4) rewards based on physical activity levels, and 5) access to their activity data on the web-interface. Those randomized to intervention: 1) can view others' activity and interact with other participants, and 2) receive rewards based on physical activity levels throughout the intervention (vs. at the end of the intervention for control group).
Unique, scalable, and portable physical activity interventions that motivate young survivors are needed. This study will inform future web-based physical activity interventions for children with cancer by demonstrating effects of rewards and social interaction.
ClinicalTrials.gov Identifier: NCT03223753; COG Identifier: ALTE1631.
儿童癌症治疗后不久即进行身体活动可能有益于健康，因为在治愈性治疗期间久坐的生活方式可能会使身体和情绪并发症持续存在。本研究的主要目标是评估为期 6 个月的基于网络的、基于奖励的身体活动干预对健身、心脏代谢健康生物标志物、炎症、脂肪因子状态、生活质量和出勤率的影响，并确定干预对心脏代谢健康标志物的影响是否通过健身的变化来介导。主要研究结果为干预结束时的健身（生理成本指数、六分钟步行测试）。
这是一项正在进行的、两臂、前瞻性、随机设计的研究，干预组和对照组的入组目标分别为 192 名儿童。年龄≥8 岁且<16 岁，不符合身体活动推荐水平，且在过去 12 个月内完成治疗的儿童有资格参加。两组均接受以下内容：1）鼓励身体活动的教育材料，2）活动监测器，3）访问旨在促进身体活动的基于网络的界面，4）基于身体活动水平的奖励，以及 5）访问其在网络界面上的活动数据。随机分配到干预组的儿童：1）可以查看他人的活动并与其他参与者互动，以及 2）在整个干预过程中（而不是对照组在干预结束时）根据身体活动水平获得奖励。
需要独特、可扩展且便携的能够激励年轻幸存者的身体活动干预措施。本研究通过展示奖励和社交互动的效果，为儿童癌症的未来基于网络的身体活动干预措施提供信息。
ClinicalTrials.gov 标识符：NCT03223753；COG 标识符：ALTE1631。
