Testing the feasibility and preliminary efficacy of a multilevel intervention to promote physical activity among patients with metabolic syndrome

测试多层次干预促进代谢综合征患者体力活动的可行性和初步效果

• 批准号: 9417958
• 负责人: Rachel A. Millstein
• 金额: $ 16.67万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-02-01 至 2022-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9417958
• 关键词: Accelerometer; Address; Adult; Affect; Affective; Applied Research; Area; Award; Behavior Therapy; Behavioral; Behavioral Medicine; Behavioral Research; Biometry; Blood Pressure; Cardiac; Cardiovascular Diseases; Central obesity; Chronic Disease; Clinic; Clinical; Clinical Research; Clinical Trials; Communities; Computer software; Consult; Custom; Data; Development; Diabetes Mellitus; Diet; Disease; Doctor of Philosophy; Dyslipidemias; Educational workshop; Enrollment; Environment; Epidemiology; Funding; Future; General Hospitals; Goals; Health; Health Care Costs; Health Insurance Portability and Accountability Act; Health Promotion; Health Psychology; Health Sciences; Health behavior; Health behavior change; Impairment; Individual; Institutional Review Boards; Intervention; Intervention Studies; Interview; Investigation; Lead; Learning; Massachusetts; Measurement; Measures; Medical; Mental Health; Mentored Patient-Oriented Research Career Development Award; Mentors; Mentorship; Metabolic syndrome; Modality; Modeling; Morbidity - disease rate; Motivation; National Heart, Lung, and Blood Institute; Neighborhoods; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Organ; Outcome; Participant; Patient Care; Patient Recruitments; Patient Self-Report; Patients; Peer Review; Phase; Physical activity; Pilot Projects; Play; Postdoctoral Fellow; Preparation; Prevalence; Prevention; Primary Health Care; Process; Psychiatry; Psychology; Public Health; Publications; Qualitative Research; Randomized Controlled Trials; Recommendation; Research; Research Design; Research Personnel; Resources; Risk; Risk Factors; Route; Running; Services; Social Environment; Statistical Methods; Surveys; Teaching Hospitals; Technology; Testing; Theoretical model; Time; Training; Training Support; United States National Institutes of Health; Walking; Well in self; Work; base; behavior change; behavior measurement; built environment; burden of illness; cardiometabolic risk; career; career development; catalyst; clinically relevant; community based participatory research; cost; disorder prevention; electronic data; environmental intervention; evidence base; experience; glucose metabolism; group intervention; high risk population; implementation research; improved; lifestyle intervention; medical schools; moderate-to-vigorous physical activity; mortality; motivational enhancement therapy; novel; novel strategies; nutrition; optimism; patient oriented; physical conditioning; pilot trial; positive emotional state; prevent; programs; psychologic; research and development; research data dissemination; responsible research conduct; sedentary; sedentary lifestyle; skills; social; social group; theories; therapy development; treatment as usual; treatment effect; usual care arm; walkability; working group

PROJECT SUMMARY/ ABSTRACT Candidate. I am a psychology post-doctoral research and clinical fellow with the Massachusetts General Hospital Cardiac Psychiatry Research Program. I hold a PhD in clinical health psychology and a master of health science (MHS) degree in epidemiology. I have first- or co-authored 26 peer-reviewed publications focusing on individual, group, and community-based strategies for physical activity and nutrition promotion, obesity and chronic disease prevention, and the intersection of mental and physical health. My short-term career goals are to develop and refine my clinical research skills with a focus on physical activity promotion. I plan to develop the skills I need to lead a clinical research program by pursuing this K23 award. This award would support my long-term career goals by providing me with the skills to become an independent researcher focused on developing novel interventions to promote physical activity for chronic disease prevention. If the proposed intervention proves successful, it will provide data to pursue future research using this intervention, thereby building the evidence base for patient-oriented multilevel physical activity interventions. Career Development. I will develop this intervention based on relevant theory, patient input, and expertise from my mentorship team: Dr. Jeff Huffman (clinical research, positive psychology), Dr. Elyse Park (qualitative research, motivational interviewing), Dr. Anne Thorndike (metabolic syndrome, environmental interventions), and Dr. Brian Healy (biostatistics). My team consultants, Dr. I-Min Lee (physical activity, measurement) and Dr. Lisa Quintilliani (community-based research, dissemination and implementation) will provide further expertise to support my training goals and research plan. The intervention development, testing, and dissemination process, along with relevant coursework, seminars, and workshops, will support my four training goals: 1) developing analytic skills for qualitative, clinical, and multilevel data, 2) becoming an expert in metabolic syndrome risk and prevention, 3) learning cutting-edge and technology-based physical activity and sedentary behavior measurement, and 4) dissemination and implementation of research findings. Environment. I will conduct this project at Massachusetts General Hospital (MGH), a Harvard Medical School teaching hospital, using its extensive resources for training and supporting clinical researchers and performing top-quality research. The MGH Cardiac Psychiatry Research Program (CPRP), my current research group, will be the primary setting for this award. Led by my primary mentor, Dr. Huffman, the group has performed numerous health promotion trials in patients with cardiovascular disease and diabetes. The CPRP is actively enrolling participants for five trials, including an NHLBI-funded R01 treatment development trial of positive psychology and motivational interviewing in cardiac patients. I will recruit patients from two primary care clinics that are actively engaged in research. I will also collaborate with the MGH Behavioral Medicine Service, a large research and clinical program that aims to develop and validate behavioral interventions for individuals with medical illness. The MGH Clinical Research Program and Harvard Catalyst programs will also support my proposed project with clinical research consulting services, seminars and courses on the responsible conduct of research, IRB preparation, and using HIPAA and research-compliant electronic data capture software. Research development and design. The overall aim of this project is to develop and test a behavioral intervention to increase physical activity among patients with metabolic syndrome (MetS) who are insufficiently active. MetS affects about 34% of US adults and is comprised of five cardio-metabolic risk factors that are strongly associated with an increased risk of type 2 diabetes, cardiovascular disease, and related mortality. Physical activity plays a key role in preventing progression from MetS to these diseases, but a majority of people with MetS risk factors do not meet physical activity recommendations. The goal of this project is to identify insufficiently active primary care patients with MetS risk factors and help them increase their physical activity by creating a multilevel intervention addressing targets at the individual, social, and environmental levels. This project will develop and test a combined positive psychology and motivational interviewing intervention in a group setting and have participants complete a neighborhood walkability assessment. I plan to follow the NIH-supported ORBIT model for health behavior change intervention development to create the intervention in three phases: 1) qualitative research and intervention development (N=20), 2) a feasibility pilot trial and intervention refinement (N=16), and 3) a small randomized controlled trial (N=64). The specific aims are to sequentially develop the intervention and test its feasibility, acceptability, and preliminary clinical impact. The hypotheses are that this intervention i) will be feasible and acceptable, and ii) that patients in the intervention group will increase their physical activity, positive emotions, and related health behaviors, more than an enhanced usual care control group. This study’s aims will address important research gaps by systematically, iteratively developing a multilevel (individual, social, and environmental) physical activity intervention customized for MetS. Each study aim addresses one or more of my training goals and allows me to use the breadth of resources available at MGH and Harvard to become proficient in leading clinical trials that have a public health impact.

项目摘要/摘要 候选人。我是马萨诸塞州一般研究后的心理学研究和临床研究员 医院心脏病学研究计划。我拥有临床健康心理学博士学位 健康科学（MHS）流行病学学位。我首先合着了26个同行评审的出版物 专注于个人，团体和社区的体育锻炼和营养促进策略， 肥胖和慢性疾病预防，以及心理和身体健康的交集。我的短期 职业目标是发展和完善我的临床研究技能，以促进体育锻炼。我 计划通过获得这一K23奖来开发我需要领导临床研究计划的技能。这个奖项 通过为我提供成为独立研究人员的技能，可以支持我的长期职业目标 专注于制定新的干预措施，以促进预防慢性疾病的体育锻炼。如果是 拟议的干预措施证明了成功，它将提供数据以使用此干预措施购买未来的研究， 从而为以患者为导向的多层次体育锻炼干预建立证据基础。 职业发展。我将根据相关理论，患者投入和专业知识制定这种干预措施 来自我的Mentalship团队：Jeff Huffman博士（临床研究，积极心理学），Elyse Park博士（定性 研究，动机访谈），安妮·桑迪克（Anne Thorndike）博士（代谢综合症，环境干预措施）， 和Brian Healy博士（生物统计学）。我的团队顾问I-Min Lee博士（体育锻炼，测量）和博士 Lisa Quintiliani（基于社区的研究，传播和实施）将提供进一步的专业知识 支持我的培训目标和研究计划。干预开发，测试和传播 流程，以及相关的课程，半手和研讨​​会，将支持我的四个培训目标：1） 开发定性，临床和多级数据的分析技能，2）成为代谢的专家 综合征风险和预防，3）学习尖端和基于技术的体育锻炼以及久坐的 行为衡量，4）研究结果的传播和实施。 环境。我将在哈佛医疗的马萨诸塞州综合医院（MGH）进行此项目 学校教学医院，利用其广泛的资源进行培训和支持临床研究人员和 进行高质量的研究。我目前的MGH心脏病学研究计划（CPRP） 研究小组将是该奖项的主要环境。由我的主要导师霍夫曼博士领导的小组 在心血管疾病和糖尿病患者中进行了许多健康促进试验。这 CPRP积极招募参与者进行五项试验，包括NHLBI资助的R01治疗开发 心理学正常心理学和动机访谈的试验。我将从两个 积极从事研究的初级保健诊所。我还将与MGH行为合作 医学服务，旨在发展和验证行为的大型研究和临床计划 患有医学疾病的人的干预措施。 MGH临床研究计划和哈佛催化剂 计划还将通过临床研究咨询服务，半货币和 有关负责任的研究，IRB准备以及使用HIPAA和符合研究的课程 电子数据捕获软件。 研究开发和设计。该项目的总体目的是开发和测试行为 干预以增加代谢综合征（METS）患者的体育活动，这些患者不足 积极的。 Mets影响了约34％的美国成年人，并由五个心脏代谢风险因素组成 与2型糖尿病，心血管疾病和相关死亡率的风险增加密切相关。 体育活动在防止大都会发展到这些疾病的过程中起着关键作用，但大多数 患有大都会风险因素的人不符合身体活动建议。 该项目的目的是确定患有Mets风险因素的活性不足的初级保健患者 通过创建针对目标的多层次干预来帮助他们增加身体活动 个人，社会和环境层面。该项目将开发和测试一个积极的心理学 并在小组环境中进行动机面试干预，并让参与者完成一个社区 步行性评估。我计划遵循NIH支持的轨道模型，以进行健康行为改变 干预开发以在三个阶段创建干预措施：1）定性研究和干预 开发（n = 20），2）可行性试验试验和干预改进（n = 16）和3） 对照试验（n = 64）。具体目的是依次开发干预措施并测试其可行性， 可接受性和初步临床影响。假设是这种干预i）将是可行的，并且 可以接受的，ii）干预组中的患者将增加其体育锻炼，积极的情绪， 和相关的健康行为，不仅仅是增强的常规护理对照组。 这项研究的目标将通过系统地，迭代地开发多层次来解决重要的研究差距 （个人，社会和环境）为大都会定制的体育锻炼干预措施。每个研究的目标 解决我的一个或多个培训目标，并允许我使用MGH可用的资源广度 哈佛大学将精通带来公共卫生影响的临床试验。