Optimization and Evaluation of a Tailored Behavioral eHealth/mHealth Weight Loss Intervention for Cardiac Rehabilitation Patients Using the Multiphase Optimization Strategy

使用多阶段优化策略对心脏康复患者量身定制的行为电子健康/移动健康减肥干预措施进行优化和评估

• 批准号: 10334553
• 负责人: Carly Michelle Goldstein
• 金额: $ 18.11万
• 依托单位: MIRIAM HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-02-22 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10334553
• 关键词: Address; Adult; Affect; Area; Attention; Attenuated; Award; Behavior; Behavior Therapy; Behavioral; Behavioral Medicine; Bite; Body Weight; Body Weight decreased; Caloric Restriction; Cardiac; Cardiac rehabilitation; Cardiovascular Diseases; Cardiovascular system; Cause of Death; Cholesterol; Clinical; Community Health; Data Analyses; Devices; Diabetes Mellitus; Diet; Dietary intake; Direct Costs; Disease; Doctor of Philosophy; Environment; Evaluation; Event; Exercise; Feedback; Funding; Future; Gold; Grant; Health; Health Benefit; Health Expenditures; Health Technology; Health behavior change; Healthcare Systems; Hemoglobin; High Density Lipoproteins; Hospitals; Hypertension; Incidence; Individual; Intervention; Low-Density Lipoproteins; Maintenance; Mediator of activation protein; Medical; Mentors; Mentorship; Methodology; Methods; Monitor; Myocardial Infarction; National Heart, Lung, and Blood Institute; Obesity; Online Systems; Outcome; Outpatients; Overweight; Patient Care; Patients; Persons; Phase; Physical Education; Physical activity; Physicians; Population; Primary Health Care; Quality of life; Randomized; Randomized Controlled Trials; Rapid screening; Rehabilitation therapy; Research; Research Methodology; Research Project Grants; Resources; Risk; Scientist; Secondary to; Self Efficacy; Severities; Special Population; Statistical Methods; Structure; Supervision; Technology; Testing; Training; Triglycerides; United States; Universities; Weight; Weight Gain; Weight maintenance regimen; Work; Workplace; base; blood pressure reduction; cardiovascular risk factor; career; clinically significant; community setting; comorbidity; cost; cost effective; cost efficient; design; dietary restriction; disorder risk; eHealth; evidence base; exercise capacity; experience; experimental study; fitbit; follow-up; improved; innovation; intervention effect; mHealth; meetings; mortality; multidisciplinary; multilevel analysis; multiphase optimization strategy; novel; obesity treatment; online delivery; pilot test; programs; psychoeducation; skills; stress management; success; tool; treatment optimization; virtual; virtual reality; virtual reality intervention; weight loss intervention; weight loss program

PROJECT SUMMARY/ABSTRACT Cardiovascular disease (CVD) is the leading cause of death in the United States. Cardiac rehabilitation (CR) is an evidence-based, cost-effective, and widely-available multidisciplinary program that combines supervised exercise with psychoeducation on health behavior change aimed at improving overall health and reducing cardiovascular risk in individuals with established CVD. Despite CR's ample attention to increasing physical activity (PA) and improving diet it produces almost no weight loss (WL). WL would significantly improve the CR patients' health, the majority of who present to CR with obesity. Gold standard in-person behavioral weight loss interventions (BWLs) produce clinically significant WL that improves health and disease risk/severity, but these programs are so burdensome and costly that they are impossible to conduct within existing CR programs. The primary mentor's fully automated 3-month online program, Rx Weight Loss (RxWL), produced clinically significant mean±SD WL of 5.8±4.4 % of initial body weight in physician-referred patients (N=154), 5.8 ±5.2 % in worksites (N=75), and 4.2±5.3 % in community settings (N=230); this was maintained at 6-months. Dr. Goldstein, the candidate, aims to conduct formative work to tailor RxWL for use in CR. She will then use the Multiphase Optimization Strategy (MOST) to rapidly screen 4 innovative eHealth/mHealth intervention components with the potential to improve WL in this special population when combined with the core RxWL program. Following pilot testing with n=20, a fully-powered 24 full factorial experiment with 160 patients (each randomized to receive 0-4 of the components) will be used to test the 4 novel intervention components: (a) a tailored interactive intervention to promote structured PA using a Fitbit; (b) a bite counting device to promote caloric restriction; (c) a Web-based virtual reality (VR) intervention for BWL skills implementation; and (d) virtual meetings to increase WL self-efficacy. By the 6-month follow-up, this design will allow the candidate to determine which components maximize WL and whether there are favorable component combinations. Dr. Goldstein will test which components are (or are not) effective and why or how they exert their effects, which is critical for understanding their mechanism of action (or inaction). Each component will be required to meet a 2% WL optimization criterion for inclusion in the final treatment package. This research will result in a fully- automated BWL treatment package optimized for CR, which will be submitted for testing in a randomized controlled trial (RCT) in an R01 developed during the K23 grant period. Given the candidate's success while earning her PhD from Kent State University and completing an NHLBI-funded Cardiovascular Behavioral Medicine T32 at The Miriam Hospital and Brown University, the candidate will undoubtedly leverage the resources in her exemplary research environment to develop into a successful, independent scientist. Through a robust training plan and innovative research project, Dr. Goldstein will become one of the only independent scientists to use eHealth/mHealth technology to facilitate WL in CVD, specifically CR, patients.

项目概要/摘要 心血管疾病（CVD）是美国的首要死因。心脏康复（CR）是 一个基于证据、具有成本效益且广泛可用的多学科计划，结合了监督 运动结合关于健康行为改变的心理教育，旨在改善整体健康并减少 已确诊患有心血管疾病的个体的心血管风险。尽管CR非常重视增加体力 活动（PA）和改善饮食几乎不会产生体重减轻（WL）。 WL将显着提高CR 患者的健康状况，其中大多数患者因肥胖而出现 CR 症状。黄金标准的面对面行为减肥 干预措施 (BWL) 产生具有临床意义的 WL，可改善健康和疾病风险/严重程度，但这些 这些计划是如此繁重和昂贵，以至于不可能在现有的 CR 计划中进行。这 主要导师的全自动 3 个月在线计划 Rx Weight Loss (RxWL)，临床制作 医生转诊患者初始体重的显着平均值±SD WL 为 5.8±4.4 % (N=154)，5.8 ±5.2 % 工作场所 (N=75)，社区环境 (N=230) 为 4.2±5.3%；这一期限维持在6个月。博士。 候选人 Goldstein 的目标是开展形成性工作，定制 RxWL 以用于 CR。然后她将使用 多阶段优化策略 (MOST) 可快速筛选 4 种创新的电子医疗/移动医疗干预措施 与核心 RxWL 结合使用时，有可能改善这一特殊人群的 WL 的组件 程序。在 n=20 的试点测试之后，对 160 名患者（每个患者 随机接受 0-4 个组件）将用于测试 4 个新颖的干预组件：(a) a 使用 Fitbit 定制互动干预以促进结构化 PA； (b) 咬数计数装置，以促进 热量限制； (c) 基于网络的虚拟现实（VR）干预，以实施 BWL 技能；和（四） 虚拟会议以提高 WL 自我效能。通过 6 个月的随访，该设计将使候选人能够 确定哪些组件可以最大化 WL 以及是否存在有利的组件组合。博士。 戈德斯坦将测试哪些成分有效（或无效）以及它们为何或如何发挥作用，这就是 对于理解其作用（或不作用）机制至关重要。每个组件都需要满足 纳入最终治疗方案的 2% WL 优化标准。这项研究将产生一个完全 针对 CR 进行优化的自动化 BWL 治疗方案将提交进行随机测试 K23 资助期间开发的 R01 的对照试验 (RCT)。鉴于候选人的成功 在肯特州立大学获得博士学位并完成 NHLBI 资助的心血管行为学课程 米里亚姆医院和布朗大学的医学 T32，候选人无疑将利用 她在模范研究环境中拥有资源，成长为一名成功的独立科学家。通过 凭借强大的培训计划和创新的研究项目，戈德斯坦博士将成为唯一的独立研究人员之一 科学家们利用电子医疗/移动医疗技术来促进 CVD（特别是 CR）患者的 WL。