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Trial record 38 of 1349 for:    rural

Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina

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ClinicalTrials.gov Identifier: NCT02707432
Recruitment Status : Completed
First Posted : March 14, 2016
Last Update Posted : August 12, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
James McFarlin Community Development, Inc.
Project Momentum, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: Heart Matters Not Applicable

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.Geographic differences in heart disease mortality led Cosby et al. to describe the rural "mortality penalty" in 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina
Actual Study Start Date : March 27, 2017
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.
Other Name: PREMIER

Experimental: 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.
Behavioral: 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.
Other Name: PREMIER




Primary Outcome Measures :
  1. Weight [ Time Frame: Baseline and 6 months after initiated treatment ]
    Change in weight as measured by a scale

  2. Self reported acceptability of the program [ Time Frame: 12 months after initiated treatment ]
    Participants report on the overall intervention and training satisfaction (11 item) and content and utilization of intervention (7 item)


Secondary Outcome Measures :
  1. Change in percentage of participants with controlled blood pressure, from baseline to 6 months [ Time Frame: Baseline and 6 months after initiated treatment ]
    Controlled blood pressure is defined as 140 (systolic)/ 90 (diastolic)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707432


Locations
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United States, North Carolina
Project Momentum Inc.
Rocky Mount, North Carolina, United States, 27801
Shirley McFarlin
Rocky Mount, North Carolina, United States, 27891
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
James McFarlin Community Development, Inc.
Project Momentum, Inc.
Investigators
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Principal Investigator: Giselle Corbie-Smith, MD, MSc University of North Carolina, Chapel Hill
Principal Investigator: Mysha Wynn, MA Project Momentum, Inc.
Principal Investigator: Shirley McFarlin, BA James McFarlin Community Development, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02707432     History of Changes
Other Study ID Numbers: 13-2576
5R01HL120690-02 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Cardiovascular Diseases
Community-Based Participatory Research
African Americans
Additional relevant MeSH terms:
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Cardiovascular Diseases