Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT02707432
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), James McFarlin Community Development, Inc. (Other), Project Momentum, Inc. (Industry)
• Enrollment: 143
• Locations: 2
• Arms: 2
• Actual Duration (Months): 23.1
• Patients Per Site: 71.5
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• 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: Mar 27, 2017
• Actual Primary Completion Date: Feb 28, 2019
• Actual Study Completion Date: Feb 28, 2019

Arms and Interventions

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 Names: 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 Names: PREMIER

Outcome Measures

Primary Outcome Measures

1. Change in Weight [Baseline and 6 months after initiated treatment]

   Measured in pounds

Secondary Outcome Measures

1. Change in Systolic Blood Pressure [Baseline, Month 6]

   Blood pressure as measured in mmHg

2. Change in Diastolic Blood Pressure [Baseline, Month 6]

   As measured in mmHg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Project Momentum Inc.	Rocky Mount	North Carolina	United States	27801
2	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

• 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.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 25, 2020

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT02707432
• Other Study ID Numbers: 13-2576; 5R01HL120690-02
• First Posted: Mar 14, 2016
• Last Update Posted: Apr 9, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Cardiovascular Diseases

Study Results

Participant Flow

Arm/Group Title	Time 1 Heart Matters Intervention Group	Time 2 Heart Matters 6 Month-Delayed Intervention Group
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	72	71
COMPLETED	57	51
NOT COMPLETED	15	20

Baseline Characteristics

Arm/Group Title	Time 1 Heart Matters Intervention Group	Time 2 Heart Matters 6 Month-Delayed Intervention Group	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	72	71	143
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	51 70.8%	40 56.3%	91 63.6%
>=65 years	20 27.8%	28 39.4%	48 33.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.38 (16.23)	59.93 (12.64)	57.26 (14.69)
Sex: Female, Male (Count of Participants)
Female	54 75%	47 66.2%	101 70.6%
Male	18 25%	21 29.6%	39 27.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	72 100%	71 100%	143 100%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	72 100%	71 100%	143 100%

Outcome Measures

1. Primary Outcome

Title	Change in Weight
Description	Measured in pounds
Time Frame	Baseline and 6 months after initiated treatment

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Time 1 Heart Matters Intervention Group	Time 2 Heart Matters 6 Month-Delayed Intervention Group
Arm/Group Description	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.	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.
Measure Participants	37	34
Mean (Standard Deviation) [pounds]	0.41 (11.23)	0.92 (10.33)

2. Secondary Outcome

Title	Change in Systolic Blood Pressure
Description	Blood pressure as measured in mmHg
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Time 1 Heart Matters Intervention Group	Time 2 Heart Matters 6 Month-Delayed Intervention Group
Arm/Group Description	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.	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.
Measure Participants	38	32
Mean (Standard Deviation) [mmHg]	8.79 (19.42)	2.67 (18.01)

3. Secondary Outcome

Title	Change in Diastolic Blood Pressure
Description	As measured in mmHg
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Time 1 Heart Matters Intervention Group	Time 2 Heart Matters 6 Month-Delayed Intervention Group
Arm/Group Description	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.	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.
Measure Participants	38	32
Mean (Standard Deviation) [mmHg]	5.05 (12.96)	2.00 (10.93)

Adverse Events

Time Frame	From baseline through 18 month follow-up data collection.
Arm/Group Title	Time 1 Heart Matters Intervention Group		Time 2 Heart Matters 6 Month-Delayed Intervention Group
Arm/Group Description	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.		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.
All Cause Mortality
	Time 1 Heart Matters Intervention Group		Time 2 Heart Matters 6 Month-Delayed Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/71 (0%)
Serious Adverse Events
	Time 1 Heart Matters Intervention Group		Time 2 Heart Matters 6 Month-Delayed Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/71 (0%)
Other (Not Including Serious) Adverse Events
	Time 1 Heart Matters Intervention Group		Time 2 Heart Matters 6 Month-Delayed Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/71 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.