Smart Walk: A culturally tailored smartphone-delivered physical activity intervention to reduce cardiometabolic disease risk among African American women

摘要/项目摘要 非裔美国妇女经历了心脏代谢性疾病的沉重负担。57% 肥胖，57%有心血管疾病，12%被诊断为糖尿病。进行规律的有氧运动 体力活动是预防和管理这些心脏代谢性疾病的既定机制。这个 这项研究的目的是测试一种文化定制的、基于理论的智能手机交付的物理设备的有效性 活动干预，增加体力活动，促进全民有氧体育活动的坚持 指南，并改善非裔美国妇女的心脏代谢性疾病风险因素。在12个月内， 两组随机试验，240名久坐(即每周60分钟中等到剧烈强度的体育锻炼) 活动)患有肥胖症(即BMI和GT；30公斤/平方米)的非裔美国女性将被分配接受Smart 步行，一种文化定制的、基于社会认知理论的体力活动促进干预(n=120)，或 仅Fitbit比较臂(n=120)。智能行走干预组将收到一个文化定制的 通过Smart Walk智能手机应用程序提供的体力活动干预、虚拟体力活动指导、 和短信。Smart Walk应用程序上提供的功能包括：1)个人资料页面，2)文化 相关多媒体(即文本和视频)体育活动推广模块，3)留言/讨论板， 和4)与Fitbit活动监视器集成的身体活动自我监控/跟踪功能 参与者跟踪他们的日常、每周和每月活动。虚拟身体活动教练将积极 参与并促进讨论板上参与者之间的小组对话，并提供 通过电话或基于商业应用程序的视频进行个性化的一对一体力活动指导 电话会议软件，基于参与者的喜好。智能行走参与者还将获得三个 在为期4个月的积极干预期间，每周发送促进身体活动的短信。这个 仅限Fitbit的ARM比较臂将收到Fitbit活动监视器，并被鼓励使用商业 可用于增加体力活动的设备。我们假设智能行走干预组的参与者 在以下情况下，体力活动和心脏代谢风险因素将有显著改善 与仅使用Fitbit的对照组进行比较。主要结果包括自我报告和加速度计- 测量体力活动的变化。次要结果包括心脏代谢的传统危险因素 疾病(即体重指数、血压、血脂、糖耐量异常、胰岛素抵抗)和更多新的 以及预后危险因素，包括心肺功能、主动脉脉搏波速度、促炎性 肿瘤坏死因子-α、白介素6、抗炎生物标记物白介素10、白介素15。我们还将探索 干预效果的调解人和调解人，并确定每个参与者的总社会成本 提供智能行走干预和两个研究小组的成本效益以增加 每周中等到剧烈的体力活动分钟。

Abstract/Project Summary African American women experience a high burden of cardiometabolic disease conditions. Fifty-seven percent are obese, 57% have cardiovascular disease, and 12% have diagnosed diabetes. Engaging in regular aerobic physical activity is an established mechanism to prevent and manage these cardiometabolic diseases. The purpose of this study is test the efficacy of a culturally tailored, theory-based smartphone-delivered physical activity intervention to increase physical activity, promote adherence to national aerobic physical activity guidelines, and improve cardiometabolic disease risk factors among African American women. In a 12-month, two arm randomized trial, 240 sedentary (i.e., < 60 minutes/week of moderate-to-vigorous intensity physical activity) African American women with obesity (i.e., BMI >30 kg/m2) will be assigned to receive either Smart Walk, a culturally tailored, Social Cognitive Theory-based physical activity promotion intervention (n=120), or a Fitbit-only comparison arm (n=120). The Smart Walk intervention group will receive a culturally tailored physical activity intervention delivered via the Smart Walk smartphone app, virtual physical activity coaching, and text messages. Features available on the Smart Walk app include: 1) personal profile pages, 2) culturally relevant multi-media (i.e., text and video) physical activity promotion modules, 3) message/discussion boards, and 4) physical activity self-monitoring/tracking feature that integrates with Fitbit activity monitors for participants to track their daily, weekly, and monthly activity. Virtual physical activity coaches will actively engage and facilitate group-based dialogue among participants on the discussion boards and provide individualized, one-on-one physical activity coaching via telephone or commercially available app-based video teleconferencing software, based on participant preference. Smart Walk participants also receive three physical activity promotion text messages each week for the duration of the active 4-month intervention. The Fitbit-only arm comparison arm will receive a Fitbit activity monitor and be encouraged to use the commercially available device to increase physical activity. We hypothesize participants in the Smart Walk intervention group will demonstrate significantly greater improvements in physical activity and cardiometabolic risk factors when compared to the Fitbit-only comparison group. Primary outcomes include self-reported and accelerometer- measured changes in physical activity. Secondary outcomes include traditional risk factors for cardiometabolic disease (i.e., BMI, blood pressure, serum lipid profiles, glucose intolerance, insulin resistance) and more novel and prognostic risk factors, including cardiorespiratory fitness, aortic pulse wave velocity, pro-inflammatory biomarkers of TNF-α, IL-6, and anti-inflammatory biomarkers of IL-10 and IL-15. We will also explore mediators and moderators of intervention effectiveness and determine the total societal cost per participant of delivering the Smart Walk intervention and the cost-effectiveness of the two study groups to increase minutes/week of moderate-to-vigorous physical activity.