Smart Walk: A Culturally Tailored Smartphone-delivered Physical Activity Intervention for Reduction of 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 活动干预以增加体力活动和改善心脏代谢性疾病的危险因素 非裔美国女性。在一项为期12个月的双臂随机试验中，210名患者久坐(即每周60分钟 中等到剧烈的体力活动)肥胖的非裔美国女性(即体重指数和体重指数；30公斤/平方米)将 被分配接受智能行走，这是一种文化定制的、基于社会认知理论的身体活动 促进干预(n=105)，或仅Fitbit比较组(n=105)。智能行走干预组 将通过Smart Walk智能手机应用程序接受文化定制的身体活动干预， 虚拟体育活动指导和短信。Smart Walk应用程序提供的功能包括：1) 个人资料页面，2)与文化相关的多媒体(即文本和视频)体育活动推广 模块，3)消息/讨论板，4)身体活动自我监控/跟踪功能，集成 通过Fitbit活动监测器，参与者可以跟踪他们的日常、每周和每月活动。虚拟物理 活动教练将积极参与并促进参与者之间关于讨论的小组对话 并通过电话或商业方式提供个性化的、一对一的身体活动指导 根据参与者喜好，提供基于应用程序的视频电话会议软件。智能行走参与者 在为期4个月的活动期间，每周还会收到三条体育活动推广短信 干预。仅限Fitbit的ARM比较臂将接收Fitbit活动监视器，并鼓励使用 商业上可以买到的增加体力活动的装置。我们假设智能行走的参与者 干预组将在体力活动和心脏代谢方面有显著改善 与仅使用Fitbit的对照组比较时的风险因素。主要结果包括自我报告和 加速计-测量体力活动的变化。次要结果包括传统的风险因素 心脏代谢性疾病(即体重指数、血压、血脂、糖耐量异常、胰岛素抵抗) 以及更多新的和可预测预后的危险因素，包括心肺适合性、主动脉脉搏波速度、 炎性生物标志物肿瘤坏死因子-α、IL-6和抗炎生物标志物IL-10、IL-15。我们还将 探索干预效果的调解人和调解人，并确定每个人的社会总成本 提供智能行走干预的参与者和两个研究小组的成本效益 每周增加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 and improve cardiometabolic disease risk factors among African American women. In a 12-month, two arm randomized trial, 210 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=105), or a Fitbit-only comparison arm (n=105). 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.