University of Pittsburgh, PA, USA.
University of Pittsburgh, PA, USA.
Contemp Clin Trials. 2021 May;104:106380. doi: 10.1016/j.cct.2021.106380. Epub 2021 Mar 31.
Many studies have used the internet to promote physical activity (PA) in several settings, including the home environment, but few have been tailored for African Americans (AAs). To address this research gap, we conducted focus groups with AAs to inform the development of a web-based intervention, Physical Activity for The Heart (PATH), that leverages openly accessible platforms, such as YouTube, to promote PA in any setting.
To describe the rationale and design of a pilot randomized clinical trial (RCT), that examines the feasibility and acceptability of the PATH intervention among 30 AA adults aged 40--70 years without history of cardiovascular disease.
A 12-week, single-site, wait-listed RCT with subjects randomized 1:1 to either: 1) treatment group - participants receive the PATH intervention, including the online portal and twice a month phone calls from a PA coach, or 2) attention control group - participants receive a self-help PA handout and twice a month general health newsletter. All participants self-monitor step count using actigraphy. The primary outcomes of this 12-week, pilot RCT are recruitment, retention, and adherence to self-monitoring (Actigraph wear time) and the intervention protocol (PATH utilization). The secondary outcomes include changes in PA (step count, moderate-to-vigorous PA, exercise self-efficacy), and cardiometabolic risk (HbA1C, HDL, LDL, total cholesterol, type 2 diabetes risk score, percent body fat, weight, and waist circumference) from baseline to 12 weeks.
This study will provide PATH intervention feasibility and acceptability data among inactive AA adults and will inform a future, full-scale RCT testing efficacy.
许多研究已经利用互联网在多个环境中促进身体活动(PA),包括家庭环境,但很少有研究针对非裔美国人(AAs)。为了弥补这一研究空白,我们对 AAs 进行了焦点小组讨论,以提供信息来开发一个基于网络的干预措施,即“心脏的身体活动”(PATH),该干预措施利用可公开访问的平台,如 YouTube,在任何环境中促进 PA。
描述一项试点随机临床试验(RCT)的原理和设计,该试验检查了 PATH 干预措施在 30 名年龄在 40-70 岁、没有心血管疾病史的非裔美国成年人中的可行性和可接受性。
一项为期 12 周、单站点、等待名单 RCT,将受试者随机分为 1:1 组:1)治疗组 - 参与者接受 PATH 干预,包括在线门户和每月两次由 PA 教练的电话;或 2)对照组 - 参与者接受自助 PA 传单和每月两次的一般健康通讯。所有参与者使用计步器自我监测步数。这项为期 12 周的试点 RCT 的主要结果是招募、保留和对自我监测(计步器佩戴时间)和干预方案(PATH 使用)的依从性。次要结果包括从基线到 12 周时 PA(步数、中到高强度 PA、运动自我效能感)和心血管代谢风险(HbA1C、HDL、LDL、总胆固醇、2 型糖尿病风险评分、体脂百分比、体重和腰围)的变化。
这项研究将提供 PATH 干预措施在不活跃的非裔美国成年人中的可行性和可接受性数据,并为未来更大规模的 RCT 测试功效提供信息。