Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina

Not Applicable

Completed

Conditions: Cardiovascular Diseases

Interventions: Behavioral: Heart Matters

Registration Number: NCT02707432

Lead Sponsor: University of North Carolina, Chapel Hill

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 143

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Time 1 (T1) Intervention Group	Heart Matters	This group will be the first to receive the adapted intervention, "Heart Matters" (adapted from the PREMIER intervention). The intervention will be 12 months long.
Time 2 (T2) Intervention Group	Heart Matters	This delayed intervention group will receive the adapted intervention, "Heart Matters," six months after the T1 Intervention group. The intervention will be 12 months long.

Primary Outcome Measures

Name	Time	Method
Change in Weight	Baseline and 6 months after initiated treatment	Measured in pounds

Secondary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure	Baseline, Month 6	Blood pressure as measured in mmHg
Change in Diastolic Blood Pressure	Baseline, Month 6	As measured in mmHg