American Indians (Als) living in the Northwest have very high rates of diabetes, obesity, tobacco use, depression, and other risk factors associated with cardiovascular disease. Depression and diabetes have a pernicious effect on CVD risk and susceptibility. This study seeks to build upon the success of the 1-month, 5-session motivational interviewing (Ml) CVD prevention component of the hali?dx[w] Project (aka Healthy Heartsoriginally funded under RFA-HL-06-002;U01 HL HL087322-05). hali?dx[w] successfully culturally adapted Ml for CVD prevention for Als, trained Als to implement the intervention, and conducted a preliminary feasibility and efficacy trial. Initial results indicated that participants enthusiastically embraced the Ml component of the program;however, observations of the counselors, survey data, and feedback from participants suggest that depressive symptomatology served as a barrier to achieving CVD preventive behaviors and desired outcomes;and, that more time and attention to underlying depressive symptomatology may enhance motivation and CVD prevention behaviors, particularly among Als with pre-diabetes and Type 2 diabetes. Building upon solid preliminary CVD epidemiological data, preliminary acceptability and feasibility of utilizing an Ml approach, and motivated by the need to address elevated depression and diabetes profiles from the heli?dx[w] study, we propose to develop a 3-month, 10-session Ml-based cognitive-behayioral-adherence (MI-CBT-CVD) treatment program to address underlying depressive symptomatology, activate CVD prevention behaviors, and decrease BMI and CVD risk behaviors among 50 pre-and recently diagnosed diabetic Als at risk for CVD, The study proposes three innovative and significant aims. First, in line with community-based participatory (CBPR) principles and pre-established indigenous research protocols with the tribal community, we will conduct formative research to develop the MI-CBT-CVD intervention. Second, we will conduct a pilot randomized two group, single-site waitlist-controlled clinical trial of a 10-session, 3-month Ml-based cognitive-behavioral treatment for CVD prevention (MI-CBT-CVD) among 50 pre-and recently diagnosed diabetic Al adults with depressive symptomatology and who are also at risk for CVD. Assessments will be conducted at pre and post intervention and at 6-months (3 month follow-up). Third, we will disseminate the findings to the tribe as well as research outlets and prepare an R01 to conduct a full-scale RCT should the pilot intervention be efficacious, acceptable to the community, and feasible. The primary objectives will be to determine the effect of the proposed culturally-grounded behavioral intervention program on (a) reducing weight as measured by BMI (7- 10% reduction in BMI);(b) decreasing depressive symptomatology;(c) increasing physical activity;(d) decreasing sedentary activities;(d) increasing healthful food habits;and (e) improving biomedical outcomes (e.g., blood lipid profiles, glucose, hemoglobin AIC, hs-CRP, and blood pressure). The intervention will be culturally relevant and utilize existing Native resources and personnel wherever possible.
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