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

习惯设计：在代谢综合征的背景下测试一种新的企业健康行为方法

• 批准号: 10210291
• 负责人: Michael Kim
• 金额: $ 72.59万
• 依托单位: HABIT DESIGN, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10210291
• 关键词: Address; Adherence; Adult; Affect; American; Android; Behavior; Behavioral; Behavioral Model; Blood Glucose; Blood Pressure; Body mass index; Cardiovascular Diseases; Central obesity; Chronic; Companions; Computer software; Consumption; Cues; Development; Effectiveness; Employee; Employee Health; Environment; Exercise; Fasting; Feedback; Female; Food; Fostering; Gender; Goals; Habits; Health; Health Care Costs; Health behavior; High Density Lipoprotein Cholesterol; High Density Lipoproteins; Hypertension; Hypertriglyceridemia; Intake; Intervention; Link; Location; Machine Learning; Maintenance; Malignant Neoplasms; Manuals; Measures; Metabolic syndrome; Modeling; Monitor; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Outcome; Participant; Patient Self-Report; Persons; Phase; Phase II Clinical Trials; Physical activity; Psychological reinforcement; Psychology; Public Health; Randomized; Randomized Controlled Trials; Research; Rewards; Risk Factors; Science; Self Efficacy; Social support; System; Telephone; Test Result; Testing; Time; Translating; Triglycerides; Water; Water consumption; Wellness Program; Workplace; base; behavior change; behavioral health; cardiovascular disorder risk; contingency management; crowdsourcing; design; effectiveness evaluation; experience; financial incentive; fitbit; follow-up; fruits and vegetables; health related quality of life; improved; innovation; male; mobile computing; novel; peer coaching; peer support; primary outcome; programs; prototype; randomized trial; satisfaction; screening; secondary outcome; smartphone Application; social learning; standard care; sugar; sweetened beverage; usability; waist circumference; web-based assessment

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.

摘要 代谢综合征（MetS）是一系列危险因素-甘油三酯（TG）升高， 高密度脂蛋白胆固醇（HDL-C）、高血压（BP）、高空腹血糖（FBG）， 和高于阈值的腰围（WC）-这与心血管疾病的增加有关， 2型糖尿病和某些癌症。研究表明，通过 工作场所可以大大有利于员工的健康和雇主的医疗保健成本。Habit Design，Inc.具有 开发了一个增强的行为健康教练系统，称为习惯设计（HD），这是第一个 在智能手机应用程序中集成习惯形成、应急管理和社会学习方法 支持企业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 调整HD方法以解决MetS。在第一阶段，我们将1）改进和扩展现有的功能原型 的高清应用程序，以支持最新版本的iOS和Android，2）进行可用性测试与8有针对性的结束 为II期临床试验准备标准治疗手册。在第二阶段，我们将1） 根据第一阶段可用性测试的结果指示HD应用程序的变更，2）评估 在一项随机试验中，HD教练与标准健康教练相比的有效性， 健康计划参与者谁有代谢综合征，随访跨越一年。参与者将员工 辛辛那提的TriHealth公司，他们已经完成了健康检查，这是他们公司健康计划的一部分 并且被鉴定为具有以下至少3/5：1）TG ≥150 mg/dL），2）HDL-C <40 mg/dL（男性） 女性血压≥130/85 mm Hg，4）FBG ≥100 mg/dl，5）男性WC ≥102 cm，≥80 女性中的cm所有参与者都将接受教练指导，以增加体力活动，并将通过 腰上佩戴的FitBit和FitBit软件此外，受试者将在随机分组前选择以下目标： 增加水果和蔬菜的摄入量或以水代替含糖饮料。条件将 按目标和性别分层。在这两种情况下，将对教练的忠诚度进行监控， 每周12次30分钟的面对面会议，然后每月1次30分钟的维护会议， 个月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、4个月、8个月和12个月时。次要结局将是标准单位增加 水果/蔬菜摄入量或水摄入量，根据参与者的选择。三级成果将包括 在每个时间点测量FBG、TG、HDL、BP、WC和体重指数。此外，我们将进行 基于网络的自我报告体力活动、垃圾食品和含糖饮料评估 消费;运动和水果，蔬菜和水消费的自动性;自我效能和社会 对目标行为的支持;以及与健康有关的生活质量。可用性、满意度和应用程序评级 将检查使用度量。假设失访率为15%，将进行意向治疗分析。