Indigeous Wellness Research Institute National Center of Excellence Research Cor

生活在西北部的美洲印第安人（ALS）有非常高的糖尿病，肥胖，烟草使用，抑郁症和其他与心血管疾病相关的风险因素。抑郁症和糖尿病对心血管疾病的风险和易感性有有害影响。本研究旨在建立在成功的1个月，5届动机面试（MI）心血管疾病预防组成部分的哈利？dx[w]项目（又名健康心脏计划 根据RFA-HL-06-002; U 01 HL HL 087322 -05供资）。hali？dx[w]成功地在文化上适应了Ml以预防Als的CVD，训练Als实施干预，并进行了初步的可行性和功效试验。最初的结果表明，参与者热情地接受了该计划的MI部分;然而，顾问的观察，调查数据和参与者的反馈表明，抑郁症是实现CVD预防行为和期望结果的障碍;并且，更多的时间和关注潜在的抑郁症可能会增强动机和CVD预防行为，特别是在患有糖尿病前期和2型糖尿病的Als中。建立在坚实的初步心血管疾病流行病学数据，初步的可接受性和可行性，利用MI的方法，并出于需要解决升高的抑郁症和糖尿病档案从直升机？dx[w]研究，我们 提出开发一个3个月，10个疗程的基于MI的认知-认知-口腔-依从性（MI-CBT-CVD）治疗方案，以解决潜在的抑郁性糖尿病，激活CVD预防行为，并在50名有CVD风险的术前和近期诊断的糖尿病AI中降低BMI和CVD风险行为。第一，基于社区的参与性（CBPR） 原则和预先建立的土著研究协议与部落社区，我们将进行形成性研究，以开发MI-CBT-CVD干预。其次，我们将在50名患有糖尿病的前和最近诊断的糖尿病Al成人中进行一项10个疗程、3个月的基于MI的认知行为治疗以预防CVD（MI-CBT-CVD）的试点随机两组、单点等待名单对照临床试验， 抑郁症患者以及有CVD风险的患者。将在干预前后和6个月（3个月随访）时进行评估。第三，我们会向部落和研究机构发放研究结果，并准备一份R 01，以便在试验性干预措施有效、为社区接受和可行的情况下，进行全面的随机对照试验。主要目标将是确定 提出的基于文化的行为干预计划：（a）减轻体重，以体重指数衡量（体重指数降低7- 10%）;（B）减少抑郁症;（c）增加体力活动;（d）减少久坐不动的活动;（d）增加健康的饮食习惯;（e）改善生物医学结果（例如，血脂谱、葡萄糖、血红蛋白AIC、hs-CRP和血压）。干预措施将具有文化相关性，并尽可能利用现有的土著资源和人员。

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.