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疾病状况的高负担。百分之五十七 57%的人患有心血管疾病，12%的人被诊断为糖尿病。定期参加有氧运动 身体活动是预防和管理这些心脏代谢疾病的既定机制。的 本研究的目的是测试根据文化定制、基于理论的智能手机提供的物理治疗的功效 活动干预，以增加身体活动，促进坚持国家有氧体育活动 指南，并改善非裔美国妇女的心脏代谢疾病的危险因素。在12个月内， 两组随机试验，240名久坐者（即，< 60分钟/周的中等至剧烈强度的体力活动 活动）患有肥胖症的非洲裔美国妇女（即，BMI >30 kg/m2）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身体活动促进干预（n=120），或 仅Fitbit比较组（n=120）。智能步行干预组将接受文化定制的 通过智能步行智能手机应用程序提供的身体活动干预，虚拟身体活动指导， 和短信Smart Walk应用程序提供的功能包括：1）个人资料页面，2）文化 相关多媒体（即，文本和视频）身体活动促进模块，3）消息/讨论板， 和4）身体活动自我监测/跟踪功能，与Fitbit活动监测器集成， 参与者跟踪他们的每日，每周和每月活动。虚拟体育教练将积极 参与和促进讨论板参与者之间的小组对话，并提供 通过电话或基于应用程序的商业视频进行个性化的一对一身体活动辅导 电话会议软件，基于参与者的偏好。Smart Walk参与者还将获得三个 在4个月的积极干预期间，每周发送身体活动促进短信。的 仅使用Fitbit的手臂比较手臂将获得Fitbit活动监测器，并鼓励使用商业化的 可用的设备，以增加体力活动。我们假设智能步行干预组的参与者 当身体活动和心脏代谢风险因素得到显着改善时， 与仅使用Fitbit的对照组相比。主要结果包括自我报告和加速计- 测量身体活动的变化。次要结局包括心脏代谢的传统风险因素 疾病（即，BMI、血压、血脂谱、葡萄糖耐受不良、胰岛素抵抗）和更新颖的 和预后风险因素，包括心肺功能，主动脉脉搏波速度，促炎性 TNF-α、IL-6的生物标志物以及IL-10和IL-15的抗炎生物标志物。我们还将探索 中介者和调解人的干预效果，并确定总社会成本，每参与者 提供智能步行干预和两个研究组的成本效益，以增加 分钟/周的中度到剧烈的身体活动。

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.