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

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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.