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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL120690-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| James McFarlin Community Development, Inc. | OTHER |
| Project Momentum, Inc. | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart Matters | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Measured in pounds | Baseline and 6 months after initiated treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure | Blood pressure as measured in mmHg | Baseline, Month 6 |
| Change in Diastolic Blood Pressure | As measured in mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Project Momentum Inc. | Rocky Mount | North Carolina | 27801 | United States | ||
| Shirley McFarlin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31925605 | Derived | 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. | |
| 30064398 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Data were available for 139 participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Weight | Measured in pounds | Data reported only for participants with both Baseline and Month 6 data. | Posted | Mean | Standard Deviation | pounds | Baseline and 6 months after initiated treatment |
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From baseline through 18 month follow-up data collection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Hoover, PhD | University of North Carolina at Chapel Hill | 919-966-1649 | stephanie_hoover@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2020 | Feb 26, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C096535 | Permadyne Premier |
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| Baseline, Month 6 |
| Rocky Mount |
| North Carolina |
| 27891 |
| United States |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Data were available for 139 participants | Mean | Standard Deviation | years |
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| Sex: Female, Male | Data were available for 140 participants | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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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.
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| Secondary | Change in Systolic Blood Pressure | Blood pressure as measured in mmHg | Data reported only for participants with both Baseline and Month 6 data. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 6 |
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| Secondary | Change in Diastolic Blood Pressure | As measured in mmHg | Data reported only for participants with both Baseline and Month 6 data. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 6 |
|
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| 0 |
| 72 |
| 0 |
| 72 |
| 0 |
| 72 |
| EG001 | 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. | 0 | 71 | 0 | 71 | 0 | 71 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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