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Clinical Trials/NCT02707432
NCT02707432
Completed
Not Applicable

Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina

University of North Carolina, Chapel Hill2 sites in 1 country143 target enrollmentMarch 27, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
University of North Carolina, Chapel Hill
Enrollment
143
Locations
2
Primary Endpoint
Change in Weight
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 27, 2017
End Date
February 28, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Evidence of active or unstable CVD
  • Cognitive impairment that limits informed consent

Outcomes

Primary Outcomes

Change in Weight

Time Frame: Baseline and 6 months after initiated treatment

Measured in pounds

Secondary Outcomes

  • Change in Systolic Blood Pressure(Baseline, Month 6)
  • Change in Diastolic Blood Pressure(Baseline, Month 6)

Study Sites (2)

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