The HHER Lifestyle Program for CVD Risk Reduction

描述(申请人提供)：心血管疾病(CVD)是美国女性死亡的主要原因，每年夺走的生命比所有癌症的总和还要多。非裔美国人(AA)女性的心血管疾病和冠心病(CHD)发病率和死亡率明显高于白人女性。医疗保健场所是就降低心血管疾病风险向个人提供咨询的绝佳场所。然而，到目前为止，很少有研究测试基于医疗保健的干预措施在再生障碍性贫血妇女或经济困难人群中的有效性。这项研究的总体目标是心脏健康和种族相关(HHER)生活方式计划，旨在促进我们对如何在35岁及以上的经济困难的AA妇女的医疗保健环境中有效地促进降低心血管疾病风险的理解。拟议的随机临床试验建立在研究人员最近完成的形成性和可行性研究的基础上。我们建议培训初级保健提供者提供简短的量身定制[基于跨理论模型(TTM)]的行为咨询，并设置护士辅助的目标。提供者的患者将被随机分配到干预或标准护理中。接受干预的患者(n=156)将接受全面的、基于理论的干预，包括在基线和常规诊所就诊时由提供者提供量身定制的咨询和目标设定，社区资源指南，每月时事通讯和每月电话咨询。标准护理条件(n=156)将在基线上接受由提供者提供的量身定制的咨询和目标设定，以及关于饮食和PA的通用健康教育材料和社区资源指南。社会生态模型将被用来概念化干预，社会认知理论和TTM将指导干预目标和技术。参与者将在基线、6个月和12个月进行评估。主要结果是每周进行几分钟中等强度的PA和膳食脂肪摄入。次要结果是体重和血液胆固醇。作为第二个目标，我们还建议检查与SCT、社会生态模型和TTM一致的结构在调节PA和饮食变化中的作用。

DESCRIPTION (provided by applicant): Cardiovascular disease (CVD) is the leading cause of death for women in the United States, claiming more lives each year than all cancers combined. CVD and coronary heart disease (CHD) morbidity and mortality rates are significantly higher in African American (AA) women than in white women. Health care sites are excellent settings in which to counsel individuals regarding CVD risk reduction. Few studies to date, however, have tested the effectiveness of health care-based interventions with AA women or financially disadvantaged populations. The overall goal of this study, the Heart Healthy and Ethnically Relevant (HHER) Lifestyle Program, is to advance our understanding of how to effectively promote CVD risk reduction in health care settings among financially disadvantaged AA women ages 35 years and older. The proposed randomized clinical trial builds on recently completed formative and feasibility studies conducted by the investigators. We propose to train primary care providers to deliver brief tailored [based on the Transtheoretical Model (TTM)] behavioral counseling with nurse assisted goal setting. Patients of providers will be randomly assigned to intervention or standard care. Patients in the intervention condition (n=156) will receive a comprehensive, theory-based intervention that includes tailored provider-delivered counseling and goal-setting at baseline and at routine clinic visits, a community resource guide, a monthly newsletter and monthly telephone counseling. The standard care condition (n=156) will receive tailored provider-delivered counseling and goal-setting at baseline with generic health education materials on diet and PA and a community resource guide. A social ecological model will be used to conceptualize the intervention, and social cognitive theory and the TTM will guide the intervention targets and techniques. Participants will be assessed at baseline, 6, and 12 months. The primary outcomes are minutes per week of moderate intensity PA and dietary fat intake. The secondary outcomes are body weight and blood cholesterol. As a secondary aim, we also propose to examine the role of constructs consistent with SCT, social ecological models, and the TTM in mediating change in PA and diet.