Cardiovascular DiseasesNCT02707432
Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina
A study testing Heart Matters in people with Cardiovascular Diseases, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Heart Matters
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Mar 2017to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Evidence of active or unstable CVD
- Cognitive impairment that limits informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Project Momentum Inc.
Rocky Mount, North Carolina, 27801
Shirley McFarlin
Rocky Mount, North Carolina, 27891
About this study
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.
Read the 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:
- Expand and sustain a coalition of community and academic stakeholders to develop successful CVD risk prevention strategies in rural communities;
- 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;
- Adapt PREMIER, a multi-component EBI using intervention mapping;
- 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
- Being tested
- Heart Matters
- Keywords
- Cardiovascular Diseases, Community-Based Participatory Research, African Americans
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart MattersBehavioural
Also called PREMIER
"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.
| Study group | Role | What they receive |
|---|---|---|
| Time 1 (T1) Intervention Group | Experimental | 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. Receives: Behavioral: Heart Matters |
| Time 2 (T2) Intervention Group | Experimental | 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. Receives: Behavioral: Heart Matters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Measured in pounds
Measured: Baseline and 6 months after initiated treatment
Secondary outcomes (2)
Change in Systolic Blood Pressure
Blood pressure as measured in mmHg
Measured: Baseline, Month 6
Change in Diastolic Blood Pressure
As measured in mmHg
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study start27 Mar 2017
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), James McFarlin Community Development, Inc., Project Momentum, Inc.
- Responsible party
- Sponsor
- Investigators
- Giselle Corbie-Smith, MD, MSc, Principal investigator, University of North Carolina, Chapel HillMysha Wynn, MA, Principal investigator, Project Momentum, Inc.Shirley McFarlin, BA, Principal investigator, James McFarlin Community Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707432
- Sponsor's protocol ID
- 13-2576
- Other IDs
- 5R01HL120690-02
- Status last verified
- Jan 2020
- First submitted
- 9 Mar 2016
- Last updated
- 9 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31925605Corbie-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.
PubMed 30064398
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina
- ClinicalTrials.gov ID
- NCT02707432
- Acronym / sponsor ID
- 13-2576
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular Diseases, Community-Based Participatory Research, African Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), James McFarlin Community Development, Inc., Project Momentum, Inc.
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Posted 9 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Expand and sustain a coalition of community and academic stakeholders to develop successful CVD risk prevention strategies in rural communities;
- 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;
- Adapt PREMIER, a multi-component EBI using intervention mapping;
- Conduct a small-scale randomized control trial to assess a) efficacy; and, b) feasibility and adaption of implementing adapted PREMIER in rural settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time 1 (T1) Intervention Group | Experimental | Behavioral: Heart MattersThis 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 | Experimental | Behavioral: Heart MattersThis delayed intervention group will receive the adapted intervention, "Heart Matters," six months after the T1 Intervention group. The intervention will be 12 months long. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Evidence of active or unstable CVD
- Cognitive impairment that limits informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart MattersAlso: PREMIER"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. | Behavioural | Time 1 (T1) Intervention Group, Time 2 (T2) Intervention Group |
Primary outcome
Change in Weight
Time frame: Baseline and 6 months after initiated treatment
Measured in pounds
2 secondary outcomes
Change in Systolic Blood Pressure
Time frame: Baseline, Month 6
Change in Diastolic Blood Pressure
Time frame: Baseline, Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31925605Frerichs 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.
- Derived from this study: PubMed 30064398Corbie-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giselle Corbie-Smith, MD, MSc principal investigator
University of North Carolina, Chapel Hill
Mysha Wynn, MA principal investigator
Project Momentum, Inc.
Shirley McFarlin, BA principal investigator
James McFarlin Community Development, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Matters in people with Cardiovascular Diseases, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: Baseline and 6 months after initiated treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02707432, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.