The proposed study addresses the Office of Behavioral and Social Sciences Research (OBSSR) Program Announcement Design and Development of Novel Technologies for Healthy Independent Living (PAR-14-119). The proposed pilot study will test the feasibility of two behavioral interventions - Fitness Intensive Therapy (Get FIT) vs. Get FIT+ in 50 community-dwelling seniors (? 60 years) from a primarily low-income, ethnic minority region in Southern California at intermediate and high risk (henceforth referred to as ?at risk?) for cardiovascular disease (CVD), as determined by their Framingham risk assessment scores. Despite the many research efforts and projects focused on the design and development of mHealth apps for patients with chronic illness (e.g., diabetes), very little is known about these systems? technical feasibility and effectiveness in enhancing diet and physical activity in older adults at risk for CVD. To address this gap the proposed exploratory research will compare the feasibility of Get FIT, use of a free commercially available m-Health based intervention (i.e. Lose It!) plus a wearable Fitbit Charge device to monitor physical activity patterns for 3 months and one 45-minute behavioral counseling session focused on healthy eating and exercise vs. Get FIT+ which includes all items for Get FIT and personalized text messaging for 3 months by a health coach in older adults at risk for CVD in preparation for a larger randomized clinical trial (RCT).
The specific aims of the study are to: 1) pilot-test the proposed study protocol (e.g., recruitment and enrollment strategies, implementation of both interventions, data collection and instrumentation, adequacy of protection against potential risks) to fully evaluate the impact of Get FIT vs. Get FIT+; 2) assess the effectiveness of Get FIT vs. Get FIT+ on diet (e.g., increase fruit and vegetable intake, reduce fat intake) and physical activity (e.g., increase exercise, reduce sedentary leisure time) in older adults at risk for CVD (primary outcomes) at 3 months and 6 months; 3) explore the impact of Get FIT vs. Get FIT+ on the following secondary outcomes at 3 months and 6 months: a) clinical parameters (e.g., body weight, body composition [i.e., adiposity], blood pressure, lipid profile, HgA1c); b) psychosocial factors (e.g. depression, anxiety, quality of life); and c) patient engagement (e.g., activation, retention); 4) obtain preliminary parameter estimates (e.g., sample size, potential users, use patterns, cost-effectiveness) to be used in designing future RCTs; and 5) determine the usability and acceptability of Get FIT vs. Get FIT+ using focus groups, emphasizing participants? experiences using mHealth and barriers to healthy lifestyle behaviors. We hypothesize that Get FIT+ designed to allow a health coach to monitor participant progress and goal-setting activities and provide them with feedback in real time will have greater improvements in diet and physical activity as well as clinical and psychosocial outcomes compared to Get FIT. The study will explore the short- and long-outcomes of utilizing m-Health for promoting healthy lifestyle behaviors in older adults at risk for CVD and will extend the science in this area.
PROTOCOL NARRATIVE The proposed research will to test the feasibility of Fitness Intensive Therapy (Get FIT), a m-Health based intervention plus a wearable Fitbit Charge device to monitor physical activity patterns for 3 months and one 45- minute behavioral counseling session focused on healthy eating and exercise vs. Get FIT+ which includes all items for Get FIT and personalized text messaging for 3 months by a health coach in 50 community dwelling older adults (i.e. ? 60 years) at risk for cardiovascular disease. We will measure the impact of Get FIT vs. Get FIT+ on diet and physical activity, clinical outcomes, psychosocial well-being, patient engagement, and recruitment and retention rates at 3 months and 6 months in preparation for a larger randomized clinical trial.
