Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina

NCT ID: NCT02707432

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-27
• Study Completion Date: 2019-02-28

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Time 1 (T1) Intervention Group

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.

Group Type: EXPERIMENTAL

Heart Matters

Intervention Type: 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.

Time 2 (T2) Intervention Group

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.

Group Type: EXPERIMENTAL

Heart Matters

Intervention Type: 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.

Interventions

Heart Matters

"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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PREMIER

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

James McFarlin Community Development, Inc.

OTHER

Sponsor Role: collaborator

Project Momentum, Inc.

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giselle Corbie-Smith, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Mysha Wynn, MA

Role: PRINCIPAL_INVESTIGATOR

Project Momentum, Inc.

Shirley McFarlin, BA

Role: PRINCIPAL_INVESTIGATOR

James McFarlin Community Development, Inc.

Locations

Project Momentum Inc.

Rocky Mount, North Carolina, United States

Shirley McFarlin

Rocky Mount, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31925605 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30064398 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5R01HL120690-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-2576

Identifier Type: -

Identifier Source: org_study_id