Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 4
- 主要终点
- Change in Weight
研究概览
简要总结
The study will determine the feasibility and efficacy of adapting an evidence-based intervention (EBI) to reduce cardiovascular disease (CVD) risk factors in rural African American communities and determine the acceptability of mobile technology in these communities to support behavior change.
详细描述
Cardiovascular disease (CVD), the leading cause of death in the United States (US), disproportionately burdens rural communities. CVD prevalence rates for residents of rural areas (13.1%) is higher compared to those in urban areas (11.2%) of the US. The proposed settings for this research report similar trends in CVD prevalence, where CVD and stroke are among the top three leading causes of death. In community health assessments conducted in the last three years CVD risk factors such as obesity and hypertension were among the top 10 health priorities in our target counties. Compared to residents of metropolitan areas, rural residents have higher rates of cigarette smoking, obesity, mortality from ischemic heart disease, and are physically inactive. These disparities are likely to widen; at the current rate, its estimated 50% of individuals in the US will have CVD by 2030.
Using a community-based participatory research (CBPR) approach, our specific aims for the study are to:
- Expand and sustain a coalition of community and academic stakeholders to develop successful CVD risk prevention strategies in rural communities;
- Conduct a mixed-method community needs and assets assessment based on: a) assemble, review and assess existing sources of CVD data; b) identification of community strengths and resources using a web-based survey of community, faith based, social service and healthcare organizations; c) determine the acceptability of components of CVD risk reduction EBIs and community members' perceptions of possible targets for intervention using focus group interviews; d) determine specific family influences (barriers and facilitators) on acceptability of EBI acceptability;
- Adapt PREMIER, a multi-component EBI using intervention mapping;
- Conduct a small-scale randomized control trial to assess a) efficacy; and, b) feasibility and adaption of implementing adapted PREMIER in rural settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •African American
- •Aged 21 and older
- •Has at least one of the following cardiovascular disease (CVD) risk factors: pre-diabetes, hypertension, obesity, family history of early CVD, prior CVD
- •Reside in Nash or Edgecombe counties of North Carolina
排除标准
- •Evidence of active or unstable CVD
- •Cognitive impairment that limits informed consent
结局指标
主要结局
Change in Weight
时间窗: Baseline and 6 months after initiated treatment
Measured in pounds
次要结局
- Change in Systolic Blood Pressure(Baseline, Month 6)
- Change in Diastolic Blood Pressure(Baseline, Month 6)
