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Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina

Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02707432
Enrollment
143
Registered
2016-03-14
Start date
2017-03-27
Completion date
2019-02-28
Last updated
2020-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular Diseases, Community-Based Participatory Research, African Americans

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.

Interventions

BEHAVIORALHeart 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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
James McFarlin Community Development, Inc.
CollaboratorOTHER
Project Momentum, Inc.
CollaboratorINDUSTRY
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in WeightBaseline and 6 months after initiated treatmentMeasured in pounds

Secondary

MeasureTime frameDescription
Change in Systolic Blood PressureBaseline, Month 6Blood pressure as measured in mmHg
Change in Diastolic Blood PressureBaseline, Month 6As measured in mmHg

Countries

United States

Participant flow

Participants by arm

ArmCount
Time 1 Heart Matters Intervention Group
This group will receive the adapted intervention, Heart Matters (adapted from the PREMIER intervention) immediately after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period.
72
Time 2 Heart Matters 6 Month-Delayed Intervention Group
This 6 month delayed intervention group will receive the adapted intervention, Heart Matters, six months after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period.
71
Total143

Baseline characteristics

CharacteristicTotalTime 1 Heart Matters Intervention GroupTime 2 Heart Matters 6 Month-Delayed Intervention Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
48 Participants20 Participants28 Participants
Age, Categorical
Between 18 and 65 years
91 Participants51 Participants40 Participants
Age, Continuous57.26 years
STANDARD_DEVIATION 14.69
54.38 years
STANDARD_DEVIATION 16.23
59.93 years
STANDARD_DEVIATION 12.64
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
143 Participants72 Participants71 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
143 Participants72 Participants71 Participants
Sex: Female, Male
Female
101 Participants54 Participants47 Participants
Sex: Female, Male
Male
39 Participants18 Participants21 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 720 / 71
other
Total, other adverse events
0 / 720 / 71
serious
Total, serious adverse events
0 / 720 / 71

Outcome results

Primary

Change in Weight

Measured in pounds

Time frame: Baseline and 6 months after initiated treatment

Population: Data reported only for participants with both Baseline and Month 6 data.

ArmMeasureValue (MEAN)Dispersion
Time 1 Heart Matters Intervention GroupChange in Weight0.41 poundsStandard Deviation 11.23
Time 2 Heart Matters 6 Month-Delayed Intervention GroupChange in Weight0.92 poundsStandard Deviation 10.33
Secondary

Change in Diastolic Blood Pressure

As measured in mmHg

Time frame: Baseline, Month 6

Population: Data reported only for participants with both Baseline and Month 6 data.

ArmMeasureValue (MEAN)Dispersion
Time 1 Heart Matters Intervention GroupChange in Diastolic Blood Pressure5.05 mmHgStandard Deviation 12.96
Time 2 Heart Matters 6 Month-Delayed Intervention GroupChange in Diastolic Blood Pressure2.00 mmHgStandard Deviation 10.93
Secondary

Change in Systolic Blood Pressure

Blood pressure as measured in mmHg

Time frame: Baseline, Month 6

Population: Data reported only for participants with both Baseline and Month 6 data.

ArmMeasureValue (MEAN)Dispersion
Time 1 Heart Matters Intervention GroupChange in Systolic Blood Pressure8.79 mmHgStandard Deviation 19.42
Time 2 Heart Matters 6 Month-Delayed Intervention GroupChange in Systolic Blood Pressure2.67 mmHgStandard Deviation 18.01

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026