HABIT DESIGN: TESTING A NOVEL BEHAVIORAL APPROACH TO CORPORATE WELLNESS IN THE CONTEXT OF METABOLIC SYNDROME

摘要 代谢综合征(METS)是一系列危险因素--甘油三酯(TG)升高，高脂饮食不足。 密度脂蛋白胆固醇(HDLC)、血压(BP)、空腹血糖(FBG)升高、 和门槛以上的腰围(WC)-这与心血管疾病的增加有关，类型 2糖尿病和某些形式的癌症。研究表明，通过向大都会议会发表讲话 工作场所可以大大有利于员工的健康和雇主的医疗成本。习惯设计公司，拥有 开发了一种名为习惯设计(HD)的增强型行为健康指导系统，这是第一个 将习惯养成、应急管理和社交学习方法集成到智能手机应用程序中 支持公司或员工健康环境中的行为改变。在这个快速通道项目中，我们将 采用HD方法解决大都会歌剧院的问题。在第一阶段，我们将1)改进和扩展现有的功能原型 支持最新版本的iOS和Android的高清应用程序，2)通过8个目标端进行可用性测试 用户，以及3)为第二阶段临床试验准备标准治疗手册。在第二阶段，我们将1)制作 根据阶段I可用性测试的结果指示对HD应用程序的更改，并2)评估 HD教练与标准健康教练的有效性比较--一项对424家公司进行的随机试验 健康计划参与者有大都会医院，并进行为期一年的随访。参赛者将雇用员工 作为公司健康计划的一部分，他们已经完成了健康筛查 并被鉴定为至少3/5以下：1)甘油三酯(TG-≥)150 mg/dL)，2)高密度脂蛋白胆固醇(HDLc)40 mg/dL 女性为50 mg/dl，3)血压≥为130/85 mm Hg，4)空腹血糖≥为100 mg/dl，5)男性WC≥为102 cm，≥为80 女性为厘米..将指导所有参与者增加体力活动，并将通过 腰部佩戴FitBit和Fitabase软件。此外，参与者将在随机化之前选择一个目标 增加水果和蔬菜的摄入量或用水代替含糖饮料。条件将是 根据目标和性别的选择进行分层。在这两种情况下，都将监控教练的忠诚度并交付 每周12次面对面30分钟的会话，然后每月进行一次30分钟的维护会话，共4次 月份。主要结果将是在至少一周的过程中测量的平均每日步数 在基线时，4个月、8个月和12个月。次要结果将是标准单位增加 水果/蔬菜摄入量或水摄入量，取决于参与者的选择。第三级成果将包括 在每个时间点测量空腹血糖、甘油三酯、高密度脂蛋白、血压、腰围和体重指数。此外，我们还将进行 对自我报告的体力活动、垃圾食品和含糖饮料的网络评估 运动、水果、蔬菜和水的自律性；自我效能感和社会性 对目标行为的支持；以及与健康相关的生活质量。易用性、满意度和应用程序评级 我们将检查使用情况指标。假设随访损失15%，分析将是意向性治疗。

Abstract Metabolic syndrome (MetS) is a constellation of risk factors– elevated triglycerides (TG), insufficient high- density lipoprotein cholesterol (HDL-C), elevated blood pressure (BP), elevated fasting blood glucose (FBG), and above-threshold waist circumference (WC)–that is associated with increased cardiovascular disease, type 2 diabetes mellitus, and some forms of cancer. Research suggests that addressing MetS through the workplace could significantly benefit employee health and employer healthcare costs. Habit Design, Inc., has developed an enhanced behavioral health coaching system called Habit Design (HD) that is the first to integrate habit formation, contingency management, and social learning approaches within a smartphone app to support to behavior change in corporate or employee health contexts. In this Fast Track project, we will adapt the HD approach to address MetS. In Phase I, we will 1) refine and extend existing functional prototypes of the HD app to support the latest versions of iOS and Android, 2) conduct usability testing with 8 targeted end users, and 3) prepare standard treatment manuals for the Phase II clinical trial. In Phase II, we will 1) make indicated changes to the HD app based on findings from the Phase I usability test and 2) evaluate the effectiveness of HD coaching compared to standard health coaching in a randomized trial with 424 corporate wellness program participants who have MetS, with follow-up spanning one year. Participants will employees of TriHealth in Cincinnati who have completed a health screening as part of their corporate wellness program and been identified as having at least 3/5 of the following: 1) TG ≥150 mg/dL), 2) HDL-C <40 mg/dL in males and <50 mg/dL in females, 3) BP ≥130/85 mm Hg, 4) FBG ≥100 mg/dl, and 5) WC ≥102 cm in males and ≥80 cm in females.. All participants will be coached to increase physical activity, which will be monitored with a waist-worn FitBit and Fitabase software. Additionally, participants will choose prior to randomization a goal of increasing fruit and vegetable intake or substituting water for sugar-sweetened beverages. Conditions will be stratified by choice of goal and gender. In both conditions coaching will be monitored for fidelity and delivered in 12 weekly in-person 30-minute sessions followed by one 30-minute maintenance session per month for 4 months. The primary outcome will be average daily step count measured over the course of at least one week at baseline, 4 months, 8 months, and 12 months. The secondary outcome will be standard units increase of fruit/vegetable intake or water intake, according to the participant's choice. Tertiary outcomes will consist of FBG, TG, HDL, BP, WC, and body mass index, measured at each time point. Additionally, we will conduct web-based assessment of self-reported physical activity, junk food, and sugar-sweetened beverage consumption; automaticity of exercise and fruit, vegetable, and water consumption; self-efficacy and social support for target behaviors; and health-related quality of life. Ratings of usability and satisfaction and app usage metrics will be examined. Analyses will be intent-to-treat assuming 15% loss to follow-up.