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Completed

NCT Number: NCT02707432

Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Project Momentum Inc., Rocky Mount, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart Matters

Behavioral

"Heart Matters" is an intervention adapted from PREMIER, an evidence-based, comprehensive lifestyle intervention that focuses on blood pressure as the primary outcome. To assess the feasibility and efficacy of adapting PREMIER for rural African Americans, Heart Matters will be delivered to multiple intervention groups, but at two different stages.

Other names: PREMIER

Primary outcomes

  1. Change in Weight

    Time frame: Baseline and 6 months after initiated treatment

    Measured in pounds

Secondary outcomes

  1. Change in Systolic Blood Pressure

    Time frame: Baseline, Month 6

    Blood pressure as measured in mmHg

  2. Change in Diastolic Blood Pressure

    Time frame: Baseline, Month 6

    As measured in mmHg

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • James McFarlin Community Development, Inc.
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Project Momentum, Inc.

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 14, 2016
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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