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临床试验/NCT02707432
NCT02707432已完成不适用

Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina

University of North Carolina, Chapel Hill4 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2017年3月27日最近更新:
适应症

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:

  1. Expand and sustain a coalition of community and academic stakeholders to develop successful CVD risk prevention strategies in rural communities;
  2. 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;
  3. Adapt PREMIER, a multi-component EBI using intervention mapping;
  4. 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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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