Clinical trial NCT02707432: Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina
Official title: Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Cardiovascular Diseases
Community-Based Participatory Research
African Americans
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: James McFarlin Community Development, Inc.
name: Project Momentum, Inc.
First posted: 2016-03-14
Enrollment: 143
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline and 6 months after initiated treatment
Secondary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: Baseline, Month 6
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Rocky Mount
country: United States
facility: Project Momentum Inc.
state: North Carolina
city: Rocky Mount
country: United States
facility: Shirley McFarlin
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Giselle Corbie-Smith, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Project Momentum, Inc.
name: Mysha Wynn, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: James McFarlin Community Development, Inc.
name: Shirley McFarlin, BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frerichs L, Bess K, Young TL, Hoover SM, Calancie L, Wynn M, McFarlin S, Cene CW, Dave G, Corbie-Smith G. A Cluster Randomized Trial of a Community-Based Intervention Among African-American Adults: Effects on Dietary and Physical Activity Outcomes. Prev Sci. 2020 Apr;21(3):344-354. doi: 10.1007/s11121-019-01067-5.
citation: Corbie-Smith G, Wiley-Cene C, Bess K, Young T, Dave G, Ellis K, Hoover SM, Lin FC, Wynn M, McFarlin S, Ede J. Heart Matters: a study protocol for a community based randomized trial aimed at reducing cardiovascular risk in a rural, African American community. BMC Public Health. 2018 Jul 31;18(1):938. doi: 10.1186/s12889-018-5802-1.