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

项目总结/摘要 候选人我是马萨诸塞州总医院的心理学博士后研究和临床研究员 医院心脏精神病学研究计划。我拥有临床健康心理学博士学位和 健康科学（MHS）流行病学学位。我首次或共同撰写了26篇同行评审的出版物， 侧重于个人、团体和社区的体育活动和营养促进战略， 肥胖和慢性病的预防，以及心理和身体健康的交叉。我的短期 职业目标是发展和完善我的临床研究技能，重点是促进身体活动。我 我计划通过追求这个K23奖项来发展我领导临床研究项目所需的技能。这个奖项 我将通过为我提供成为独立研究人员的技能来支持我的长期职业目标 重点是开发新的干预措施，以促进身体活动，预防慢性病。如果 建议的干预措施被证明是成功的，它将为使用这种干预措施进行未来的研究提供数据， 从而为面向患者的多层次体力活动干预建立证据基础。 职业发展。我将根据相关理论、病人的意见和专业知识来制定这种干预措施 来自我的导师团队：Jeff霍夫曼博士（临床研究，积极心理学），Elyse Park博士（定性 研究，动机访谈），安妮桑代克博士（代谢综合征，环境干预）， Brian Healy博士（生物统计学）我的团队顾问，李毅敏博士（身体活动，测量）和李博士。 丽莎Quintilliani（基于社区的研究，传播和实施）将提供进一步的专业知识 来支持我的训练目标和研究计划干预措施的开发、测试和传播 这个过程，沿着相关的课程、研讨会和讲习班，将支持我的四个培训目标：1） 发展定性，临床和多层次数据的分析技能，2）成为代谢方面的专家 综合症的风险和预防，3）学习尖端和技术为基础的身体活动和久坐 行为测量; 4）研究成果的传播和实施。 环境我将在马萨诸塞州总医院（MGH）进行这个项目，这是一个哈佛医学中心。 学校教学医院，利用其广泛的资源培训和支持临床研究人员， 进行高质量的研究MGH心脏精神病学研究计划（CPRP），我目前的 研究小组，将是这个奖项的主要设置。在我的主要导师霍夫曼博士的带领下， 在患有心血管疾病和糖尿病的患者中进行了许多健康促进试验。的 CPRP正在积极招募五项试验的参与者，包括NHLBI资助的R01治疗开发 积极心理学和动机访谈在心脏病患者中的试验。我会从两个医院 积极参与研究的初级保健诊所。我还将与MGH行为 医学服务，一个大型的研究和临床计划，旨在开发和验证行为 对患有医学疾病的个人进行干预。MGH临床研究计划和哈佛催化剂 项目还将通过临床研究咨询服务、研讨会和 关于负责任的研究行为，IRB准备，以及使用HIPAA和研究合规性的课程 电子数据采集软件。 研究开发和设计。该项目的总体目标是开发和测试一种行为 在代谢综合征（MetS）患者中增加身体活动的干预措施 活跃代谢综合征影响约34%的美国成年人，由五个心脏代谢危险因素组成， 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。 体力活动在预防MetS进展为这些疾病方面起着关键作用，但大多数人都认为， 有代谢综合征危险因素的人不符合体力活动的建议。 该项目的目标是识别具有MetS风险因素的活动不足的初级保健患者， 帮助他们通过创建多层次的干预来增加他们的身体活动， 个人、社会和环境层面。这个项目将开发和测试一个综合的积极心理学 和动机访谈干预，让参与者完成一个社区， 步行评估。我计划遵循美国国立卫生研究院支持的ORBIT模型来改变健康行为 干预开发分为三个阶段：1）定性研究和干预 开发（N = 20），2）可行性试点试验和干预措施完善（N = 16），以及3）小型随机 对照试验（N = 64）。具体目标是按顺序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， 可接受的，和ii）干预组的患者将增加他们的身体活动，积极的情绪， 和相关健康行为的影响，均高于强化常规护理对照组。 这项研究的目的是通过系统地、反复地开发一个多层次的 （个人，社会和环境）为MetS定制的身体活动干预。每个研究目标 解决了我的一个或多个培训目标，并允许我使用MGH提供的广泛资源 和哈佛成为精通领先的临床试验，有公共卫生的影响。

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.