Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina
Phase: NA
Conditions: Cardiovascular Diseases
Sponsor: University of North Carolina, Chapel Hill

Trial Title:  Cardiovascular Outcomes of an Adapted Evidence-Based Intervention for Rural 
African Americans: Heart Matters Trial 
Internal Reference Number / Short title: Heart Matters 
ClinicalTrials.gov: NCT02707432 
 
https://clinicaltrials.gov/ct2/show/NCT02707432?term=corbie&draw=2&rank=2 
 
Other Study ID Number: UNC IRB - 13-2576 
Chief Investigator: 
Giselle Corbie-Smith, MD, MSc 
Department of Social Medicine 
University of North Carolina at Chapel Hill 
Investigators:  
 
Leah Frerichs, PhD  
Tiffany L. Young, PhD  
Mysha Wynn, MA 
Shirley McFarlin, BA  
Crystal Cene, MD, MPH 
Gaurav Dave, MD, DrPH, MPH 
 
Funder:  
National Heart Lung and Blood Institute (Grant Number 
1R01HL120690) 
Approval Date: 
2/25/20 
No potential conflicts of interest. 
 
 
 

TABLE OF CONTENTS 
1. 
KEY TRIAL CONTACTS ....................................................................................................... 4 
2. 
LAY SUMMARY ................................................................................................................... 4 
3. 
SYNOPSIS ........................................................................................................................... 5 
4. 
ABBREVIATIONS ................................................................................................................. 6 
5. 
BACKGROUND AND RATIONALE ...................................................................................... 6 
6. 
OBJECTIVES AND OUTCOME MEASURES ....................................................................... 7 
7. 
TRIAL DESIGN..................................................................................................................... 8 
8. 
PARTICIPANT IDENTIFICATION ......................................................................................... 8 
8.1. 
Trial Participants .......................................................................................................................... 8 
8.2. 
Inclusion Criteria .......................................................................................................................... 8 
8.3. 
Exclusion Criteria ........................................................................................................................ 8 
9. 
TRIAL PROCEDURES ......................................................................................................... 9 
9.1. 
Recruitment .................................................................................................................................. 9 
9.1.1     Organizational Recruitment ................................................................................... 9 
9.1.2     Individual Participant Recruitment .......................................................................... 9 
9.2. 
Screening and Eligibility Assessment ...................................................................................... 9 
9.3. 
Informed Consent ........................................................................................................................ 9 
9.4. 
Randomization ........................................................................................................................... 10 
9.5. 
Blinding and code-breaking ..................................................................................................... 10 
9.6. 
Baseline Assessments ............................................................................................................. 10 
9.7. 
Subsequent Visits ..................................................................................................................... 10 
9.8. 
Sample Handling ....................................................................................................................... 10 
9.9. 
Early Discontinuation/Withdrawal of Participants ................................................................. 10 
9.10. Definition of End of Trial ........................................................................................................... 11 
10. 
SAFETY REPORTING .................................................................................................... 12 
10.1. Adverse Event Definitions ........................................................................................................ 12 
10.2. Adverse Events .............................................................................................................................  
11. 
STATISTICS ................................................................................................................... 12 
11.1. Statistical Analysis Plan (SAP) ............................................................................................... 12 
11.2. Description of Statistical Methods .......................................................................................... 12 
11.3. Sample Size Determination ..................................................................................................... 12 
11.4. Analysis Populations................................................................................................................. 12 
11.5. The Level of Statistical Significance ....................................................................................... 13 

11.6. Procedure for Accounting for Missing, Unused, and Spurious Data. ................................ 13 
11.7. Procedures for Reporting any Deviation(s) from the Original Statistical Plan ................. 13 
12. 
DATA MANAGEMENT .................................................................................................... 13 
12.1. Access to Data .......................................................................................................................... 13 
12.2. Data Recording and Record Keeping .................................................................................... 13 
13. 
QUALITY ASSURANCE PROCEDURES ........................................................................ 13 
13.1. Monitoring ................................................................................................................................... 14 
13.2. Scientific Advisory Board ............................................................................................................. 13 
14. 
PROTOCOL DEVIATIONS ............................................................................................. 14 
15. 
ETHICAL AND REGULATORY CONSIDERATIONS ...................................................... 14 
15.1. Participant Confidentiality ........................................................................................................ 14 
15.2. Expenses and Benefits............................................................................................................. 14 
16. 
PUBLICATION POLICY .................................................................................................. 14 
17. 
ARCHIVING .................................................................................................................... 14 
18. 
REFERENCES ............................................................................................................... 15 
 
 
 

1 KEY TRIAL CONTACTS 
Chief Investigator 
Giselle Corbie-Smith, MD, MSc 
323 B MacNider 
Dept Of Social Medicine 
CB# 7240 
Chapel Hill, NC 27599 
 (919) 966-7499 
gcorbie@med.unc.edu 
 
Funder(s) 
National Heart, Lung, and Blood Institute 
(NHLBI) 
5R01HL120690 
Clinical Trials Unit 
Monica Coudurier 
Clinical Trials Project Manager 
UNC-CH Office of Clinical Trials 
720 Martin Luther King, Jr. Blvd, CB 1651 
Chapel Hill, NC 27599-1651 
(919) 843-2333 Phone 
m_coudurier@unc.edu 
Statistician 
Feng-Chang Lin, PhD 
Associate Professor 
Department of Biostatistics 
2nd floor, Brinkhous-Bullitt Building  
CB #7064  
Chapel Hill, NC 27599 
(919) 966-9431 
flin@bios.unc.edu 
 
Data Safety 
Monitoring Board 
 
 
2 LAY SUMMARY  
Cardiovascular disease (CVD) is the leading cause of death in the US, however African American 
residents of rural areas in the south and southeast regions have the highest prevalence of CVD of 
any group. African Americans carry a significant burden of CVD risk factors that often co-occur; 
this burden is amplified in rural communities. CVD disparities at the intersection of race and 
geography are driven by individual risk behaviors and complicated by factors such as limited 
access to quality healthcare, socio-economic inequities, limited healthcare infrastructure and 
environmental barriers to behavior change. Interventions to ameliorate CVD burden in rural 
African American communities will require placing the individual in the context of the larger 
community and taking advantage of new technologies to support behavior change. However, how 
best to integrate mobile technology into existing evidenced based interventions (EBIs) is still an 
emerging field and social and physical environmental factors important in rural communities are 
rarely considered in existing EBIs. The proposed study will address this gap in the literature by 
determining the feasibility and efficacy of adapting an EBI to consider the environment in 
important in rural African American communities and determining the acceptability of mobile 
technology in these communities to support behavior change. The proposed study is built on the 

strong foundation of Project GRACE’s 8-year history of designing and testing interventions using 
a community-based participatory research (CBPR) approach, and individual and collaborative 
expertise in community-based CVD outreach, service and research. We have developed a 
phased CBPR study with a long-term goal to reduce rates of CVD in Eastern NC. The overall 
objective of this proposal is to assess feasibility of implementing an EBI, adapted to the needs 
and interests of a rural community in order to plan a large scale study. To that end our specific 
aims are to 1) expand and sustain a Project GRACE CVD 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; and 4) 
conduct a small-scale randomized control trial to assess a) efficacy; and, b) feasibility and 
adaption of implementing adapted PREMIER in rural settings.  
3 SYNOPSIS 
Trial Title 
Cardiovascular Outcomes of an Adapted Evidence-Based Intervention for 
Rural African Americans: Heart Matters Trial 
Internal ref. 
no. (or short 
title) 
Heart Matters 
Trial 
registration 
NCT02707432 
Date of registration: March 14, 2016 
https://clinicaltrials.gov/ct2/show/NCT02707432?term=corbie&draw=2&rank=2 
Funder  
National Heart, Lung, and Blood Institute 
(NHLBI; 5R01HL120690) 
Trial Design 
Randomized, controlled trial  
Trial 
Participants 
African American adults (21 years or older) with at least one risk factor for 
cardiovascular disease. 
 
Sample Size 
140 
Planned Trial 
Period  
Total length of the project is 18 months.  Participant’s involvement will be a 
12-month intervention with a 6-month follow-up. 
Planned 
Recruitment 
period  
March 27, 2017 – February 28, 2019 
 
Objectives 
Outcome Measures 
Timepoint(s)  
Primary 
 
To determine the effect of 
an adapted intervention, 
Heart Matters, on 
cardiovascular clinical 
outcomes. 
 
Body weight 
 
6 months 
Secondary 
 
To determine the effect of 
Heart Matters on secondary 
cardiovascular clinical 
Systolic and diastolic 
blood pressures 
6 months 
 

outcome 
Intervention(s) 
 
  
Lifestyle modification consisting of interactive group and individual visit 
sessions targeting physical activity, weight loss, and nutrition. 
 
Comparator  
No comparator intervention due to delayed control design. 
4 ABBREVIATIONS 
AE 
Adverse event 
PI 
Principal Investigator 
CT 
Clinical Trials 
GCP 
Good Clinical Practice 
5 BACKGROUND AND RATIONALE 
Purpose: To determine the effect of an adapted intervention, Heart Matters, on cardiovascular 
clinical outcomes. 
Background: African Americans in the rural southeast are disproportionately affected by 
cardiovascular disease and associated risk factors. Despite evidence-based cardiovascular 
interventions targeting clinical or behavioral risk factors, geographic and racial disparities persist 
and continue to widen. Cardiovascular disease (CVD) is the leading cause of death in the United 
States (US) with an estimated 50% of individuals in the US expected to have CVD by 2030. 
African American residents in rural areas of the south and southeast (also called the “stroke belt”) 
have the highest prevalence of CVD compared to other populations. Furthermore, CVD 
prevalence rates for residents of rural areas (13.1%) are higher compared to those in urban areas 
(11.2%) of the US. In the setting of geographic disparities, striking racial disparities in CVD risk 
factors, morbidity and mortality are exacerbated. African Americans are disproportionately 
affected by a higher burden of CVD risk factors: high blood pressure, diabetes, smoking, high 
cholesterol, and physical inactivity. This heightened risk is prevalent in both youth and older age 
groups and has increased over time. While CVD disparities at the intersection of race and 
geography are driven by a disproportionate burden of individual risk factors, racial disparities in 
rural settings are amplified by associated factors, such as limited access to quality healthcare 
services, socio-economic burden, dwindling resources, insufficient health infrastructure, and 
physical barriers to access to care. There are numerous evidence based interventions (EBIs) that 
have focused on reduction in CVD risk factors. These interventions have often focused on primary 
prevention of individual risk factors such as hypertension, diabetes, lipids, physical activity, and 
diet quality. Many of these have been developed in urban centers, and only a few have included 
participants that are reflective of geographic and racial disparities in CVD risk. 
 
Given the burden of co-morbidities in rural African American populations, interventions targeting 
only one behavior or risk factor are likely to be less successful than those using intervention 
components and concepts impacting multiple behaviors. There is a need for culturally adapted 
interventions that address multiple behavioral risk factors for CVD. Using a Community-Based 
Participatory Research (CBPR) approach, our team adapted and will implement an EBI to 
improve cardiovascular risk in African Americans living in a rural underserved setting. 
 

Participants: African Americans who reside in Edgecombe and Nash counties, aged 21 years or 
older, with at least one self-reported cardiovascular disease (CVD) risk factor.   
Potential benefits for study participants include participation in long-term lifestyle modifications 
that may result in improved diet, nutrition, and physical activity patterns, which in turn should 
decrease blood pressure and lead to an overall reduction in cardiovascular and cancer morbidity.  
 
Heart Matters Intervention: Heart Matters will use a lifestyle modification to reduce CVD risk 
factors and includes 26 interactive group sessions and 7 individual visit sessions over 12 months. 
Heart Matters lifestyle goals include: 1) reducing weight by 15 lbs. or another agreed upon goal, 
2) limiting fat intake by consuming 20–50% or less of total calories from fat, 3) limiting daily 
sodium intake to 2300 mg or less, 4) accumulating 150 min of moderate-intensity exercise each 
week, 5) limiting alcohol intake; women are advised to consume no more than one alcoholic drink 
per day and men are advised to consume no more than two alcoholic drinks per day, and 6) diet 
and physical activity tracking. 
 
Trained facilitators and co-facilitators will conduct 26 90-minute group sessions at each 
organizational site with 15–20 participants per group. Facilitators are members of the community 
who are teachers, coaches, or clergy members and have 30 min of group supervision of 
adherence to protocol for each session delivered. Co-facilitators are allied health professionals, 
such as nutritionists, nurses, and personal trainers who help deliver the educational content. All 
facilitators will participate in an extensive three-part training on intervention protocols and 
curriculum. 
 
Participants will have seven 60-min individual sessions throughout the intervention. Individual 
sessions will be pre-scheduled and conducted via phone by the facilitator. Using motivational 
interviewing techniques, facilitators will discuss participant’s progress and challenges to making 
behavior changes. Participants develop an individualized action plan at the first individual visit and 
this plan is revisited in subsequent individual visit sessions in an effort to track individual progress. 
6 OBJECTIVES AND OUTCOME MEASURES 
Objectives 
Outcome Measures  
Timepoint(s) of 
evaluation of 
this outcome 
measure (if 
applicable) 
Primary Objective 
To determine the effect of an 
adapted intervention, Heart 
Matters, on body weight. 
 
 
Body weight measured by Tanita WB-
800 Professional Digital Weight Scale 
Body weight 
measurement at 
day 0 and 6 
months after 
baseline. 
Secondary Objectives 
To determine the effect of an 
adapted intervention, Heart 
Matters, on cardiovascular clinical 
outcomes. 
Systolic and diastolic blood pressures 
are measured by the Omron 
HEM907XL-Automatic Digital Blood 
Pressure Monitor. 
All secondary 
outcomes are 
measured at day 
0 and 6 months 
after baseline. 

7 TRIAL DESIGN 
Heart Matters is a community-based randomized trial comparing the effects of implementing the 
adapted lifestyle modification intervention on cardiovascular clinical outcomes among African 
American participants in rural eastern NC. 
 
To implement Heart Matters, we will cluster individual participants within organizations that we 
recruit to participate in the study and be host sites for the intervention delivery. We will randomize 
organizations to 2 start times: Time 1 Heart Matters Intervention Group (immediately after 
baseline data collection) and Time 2 6 month-delay Heart Matters Intervention Group (6 months 
after baseline data collection). Randomization by organization will reduce the likelihood of data 
contamination given the fact that rural communities tend to be smaller and participants may be 
familiar with each other.  
 
The flow of the participant is: 1. Screening at community organization and pre-intervention data 
collection. 2. Randomization of organizations to treatment group or 6 month delayed intervention 
control, 3. 6 month assessment data collection.  
 
Data collection procedures: After the consent process, eligible individuals will complete the 
baseline data collection in a community setting. All data collection will be completed by trained 
research staff from the partner community organizations, James McFarlin Community 
Development, Inc and Project Momentum, Inc. Data collection will include biometric and 
biomarker data as well as self-report behavioral data. Trained research staff will collect biometrics 
such as weight, height, grip strength, and balance. Trained research staff who are registered 
nurses will collect blood pressure and hemoglobin A1c. Study staff will record the biometric data 
on paper forms which will be entered into REDCap, a secure web-based application for data 
management. For participants with life-threatening A1c levels, they will be immediately 
transported to emergency services, and adverse event data will be documented by research staff. 
The baseline questionnaire will include behavioral measures and structured questions on 
demographics (e.g. age, race, marital status, SES), health history, medications, CVD risk factors. 
Data collectors will enter data from the paper questionnaire forms into REDCap. 
 
8  PARTICIPANT IDENTIFICATION 
8.1 Trial Participants 
Participants with at least one risk factor for cardiovascular disease, living in one of two 
rural counties in eastern North Carolina, aged 21 years and older. 
8.2 Inclusion Criteria 
• 
Participant is willing and able to give informed consent for participation in the trial. 
• 
African American adults aged 21 years or above. 
• 
Self-reported with at least one cardiovascular disease risk factor of pre-diabetes or 
diabetes, hypertension, obesity, family history of early CVD, or prior diagnosis of CVD 
8.3 Exclusion Criteria 
The participant may not enter the trial if ANY of the following apply: 
• 
Individuals who had significant cognitive impairment or unstable cardiovascular 
disease  

• 
Cognitive impairment that limits informed consent 
9 TRIAL PROCEDURES 
 
9.1 Recruitment 
 
9.1.1 Organizational Recruitment 
We will recruit organizations to serve as recruitment and intervention sites from both 
counties (Edgecombe and Nash). We will invite potential organizations based on: (a) 
existing relationships through the Project GRACE consortium, (b) and a list of 
organizations beyond existing networks generated by our James McFarlin Community 
Development, Inc and Project Momentum, Inc collaborators. Knowing that CVD risk is 
high in older adult populations, the extended list will include senior health and civic 
organizations. Historically, faith based organizations reach a large segment of the 
minority community and are a trusted leader in the community. As a result, many 
organizations may be faith-based. 
In addition to partnering for participant recruitment, organizations will be host sites for 
intervention delivery. We will use the following inclusion criteria to evaluate each 
organization: kitchen space with refrigerator, stove and/or microwave, contact person 
from each organization available to open and close the building, and layout of how the 
used space should look at the conclusion of use. We will base final inclusion criteria on 
if the site could host the intervention for all 12 months.Of the original list of criteria, we 
will identify sufficient sites to meet sample size needed.  
 
9.1.2 Individual Participant Recruitment 
Community-based recruiters at James McFarlin Community Development, Inc and 
Project Momentum, Inc will work with organizational leaders to hold recruitment events 
at each organization. Outreach to individuals will be based on recommendations from 
organizational leaders and will include direct outreach and information sessions at 
each organization, distributing written materials/flyers, recruiting at organizational 
events and exploring the social networks of initial recruits. 
 
 
9.2 Screening and Eligibility Assessment 
We will obtain verbal informed consent from potentially eligible participants for the initial 
screening during which individuals will provide identifiable information (e.g. contact 
information) and provide medical history to determine if eligible or excluded. No re-
screening or protocol waivers will be permitted. Medical history interview will ask about 
cardiovascular disease risk factors (pre-diabetes or diabetes, hypertension, obesity, 
family history of early CVD, or prior diagnosis of CVD) and cognitive impairment.  
9.3 Informed Consent 
After the eligibility screening, we will obtain written informed consent for each eligible 
participant who decides to enroll in the study. Community partners at James McFarlin 
Community Development, Inc and Project Momentum, Inc will be responsible for enrolling 
participants into the study.  

9.4 Randomization 
Participants in organizations will be randomized by a statistician into Time 1 (immediate 
intervention delivery after baseline data collection) and Time 2 (6 month delayed 
intervention delivery) under a matched pair in order to balance the sample size between 
Arm 1 and 2. Organizations will be paired based on the number of participants, and then 
randomly assigned one organization from each pair to each arm.  
9.5 Blinding and code-breaking 
There is no blinding or code-breaking in this trial. 
9.6 Baseline Assessments 
Immediately following the consent process, eligible individuals will complete the baseline 
data collection in a community setting. All data collection is completed by trained research 
staff from the partner community organizations, James McFarlin Community Development, 
Inc and Project Momentum, Inc. Data collection will include biometric and biomarker data 
as well as self-report behavioral data. Trained research staff will collect weight. Trained 
research staff who are registered nurses will collect blood pressure and hemoglobin A1c. 
Study staff will record the biometric data on paper forms which will be entered into 
REDCap, a secure web-based application for data management. For participants with life-
threatening A1c levels, they will be immediately transported to emergency services, and 
adverse event data will be documented by James McFarlin Community Development, Inc 
and Project Momentum, Inc research staff. 
 
Trained data collectors will conduct the structured survey. The baseline questionnaire will 
include behavioral measures and structured questions on demographics (e.g. age, race, 
marital status, SES), health history, medications, CVD risk factors. Data collectors will 
enter data from the paper questionnaire forms into REDCap. 
 
9.7 Subsequent Visits 
Data collection occurs at baseline and at each 6 month interval for 18 months. 
9.8 Sample Handling 
All samples for A1C will be disposed as biohazard material immediately after collection, 
reading, and recording is complete.  
9.9 Early Discontinuation/Withdrawal of Participants  
During the course of the trial a participant may choose to withdraw early from the trial at 
any time. This may happen for a number of reasons, including but not limited to:   
• 
The occurrence of what the participant perceives as an intolerable adverse event.   
• 
Inability to comply with trial procedures  
• 
Participant decision due to circumstances outside of trial. 
 
Participants may have the following two options for withdrawal;  
 

1) Participants can withdraw from the study but permit data and samples obtained up until 
the point of withdrawal to be retained for use in the study analysis.  No further data or 
samples would be collected after withdrawal.  
 
2) Participants can withdraw completely from the study and withdraw the data and 
samples collected up until the point of withdrawal. The data and samples already 
collected would not be used in the final study analysis. (Any limits to this type of 
withdrawal where, for example analysis of their data or samples has already been 
integrated into interim results or dose escalation decisions etc. should be explained in 
the participant information sheet).  
 
In addition, the Investigator may discontinue a participant from the trial treatment at any 
time if the Investigator considers it necessary for any reason including, but not limited to: 
• 
Ineligibility (either arising during the trial or retrospectively having been overlooked at 
screening) 
• 
An adverse event which requires discontinuation of the trial or results in inability to 
continue to comply with trial procedures 
9.10 Definition of End of Trial 
The end of trial is the point at which all the data has been collected and entered and no 
participant contact is needed.  
10 SAFETY REPORTING 
 
Safety reporting will be addressed during routing study team meetings and additional as needed 
meetings or communication. The PI and study coordinator will report any safety issues to the IRB. 
The IRB will be notified of any safety issues that necessitate reporting and possible protocol 
changes.  Progress reports will be provided to the IRB at least annually, or as requested.  All 
unanticipated problems or serious adverse events involving risk to human subjects will be 
reported.  All collaborators, students, and employees assisting in this research study will be 
informed about these obligations.   
 
10.1 Adverse Event Definitions 
Adverse Event (AE) 
Any untoward medical occurrence in a participant to whom a 
medicinal product has been administered, including occurrences 
which are not necessarily caused by or related to that product. 
Serious Adverse Event 
(SAE) 
A serious adverse event is any untoward medical occurrence 
that: 
• results in death 
• is life-threatening 
• requires inpatient hospitalisation or prolongation of existing 
hospitalisation 
• results in persistent or significant disability/incapacity 
• consists of a congenital anomaly or birth defect*. 

Other ‘important medical events’ may also be considered a 
serious adverse event when, based upon appropriate medical 
judgement, the event may jeopardise the participant and may 
require medical or surgical intervention to prevent one of the 
outcomes listed above. 
 
10.2 Adverse Events 
In the event of an adverse event, the PI and study team will work with the IRB to 
determine a protocol for handling AE that may occur during the course of data collection 
and the intervention. Facilitators and data collectors will be trained to follow protocol 
procedures and report any AE to the primary investigator immediately. 
11 STATISTICS 
 
11.1  Statistical Analysis Plan (SAP) 
The plan for the statistical analysis of the trial are outlined below. There is not a separate 
SAP document in use for the trial. 
11.2  Description of Statistical Methods                                                                                             
Demographics and clinical measures will be described using means, standard deviations, 
frequencies, and percentages. T-tests will be used to compare group level characteristics 
of continuous variables. Pearson Chi-square tests will be used to compare categorical 
group comparisons. Treatment effects from baseline to 6 months post intervention will be 
analyzed using linear mixed effects models. Least square means differences will be used 
by finding the differences between baseline and 6-month outcomes, as well as differences 
in groups with corresponding 95% confidence intervals.  Models will be adjusted for age, 
blood pressure medications, and cluster. All of the analysis will be implemented using SAS 
9.4 (Cary, NC).  
 
11.3 Sample Size Determination 
Sample size for Heart Matters was calculated on the basis of observing a 1.8 kg difference 
(SD = 3.2) in the primary outcome – weight change – between two intervention groups 
from baseline to 6 months. We determined a sample of 102 would allow us to detect a 1.8 
kg difference (SD = 3.2) in weight change between intervention and control groups, with 
80% power and an α of 0.05. Accounting for attrition and intra-class correlation, due to a 
clustered randomized delayed intervention design, we plan to enroll 120 participants. 
11.4  Analysis Populations  
We will implement Heart Matters in Edgecombe and Nash counties; two counties in 
eastern North Carolina that are considered rural by urbanized area definitions with 
respective populations of 54,150 and 93,919. The two counties share one urbanized area, 
the city of Rocky Mount. Both have had a large prevalence of African Americans (56.7 and 
40% of population, respectively) that experience significant health disparities with respect 
to cardiovascular disease. The sample is recruited through community organizations and 

thus not considered a randomly selected sample representative of populations.  
11.5 The Level of Statistical Significance 
A p-value smaller than 0.05 will be considered statistically significant. 
 
11.6 Procedure for Accounting for Missing, Unused, and Spurious Data 
For all measures, scores will be calculated if an individual answered at least 60% of the 
items of a given measure.  If an individual answered less than 60% of items, the data will 
be treated as missing for that measure only. 
11.7 Procedures for Reporting any Deviation(s) from the Original Statistical Plan 
Any deviations from the original statistical analysis plan will be reported in publications. 
12 DATA MANAGEMENT 
Data collection will include biometric and biomarker data as well as self-report behavioral data. 
Hard copy files of data will be retained in locked containers in locked rooms where approved 
study staff will have access. Data will be entered in REDCap, a secure web-based application for 
data management. All export of data from REDCap will adhere to university protocols to ensure 
data is safely stored on university approved servers.  
12.1 Access to Data 
Direct access will be granted to authorized representatives from the Sponsor, host 
institution and the regulatory authorities to permit trial-related monitoring, audits and 
inspections. 
12.2 Data Recording and Record Keeping 
Trained research staff will collect weight and other data collection except trained research 
staff who are registered nurses will collect blood pressure and hemoglobin A1c. Study staff 
will record the biometric data on paper forms, which will be entered into REDCap, a secure 
web-based application for data management. REDCap provides timestamped tracking to 
allow for an audit trail of all revisions to database codebook and data itself. Any quality 
assurance reviews and corrections to data entry will be tracked through REDCap.  
Hard copy files will be stored at UNC. The participants will be identified by a unique trial 
specific number and/or code in any database.  The name and any other identifying detail 
will NOT be included in any trial data electronic file. Informed consent documents and a 
document linking file that links participant ID to their name will be stored separately from 
all data.  
13 QUALITY ASSURANCE PROCEDURES 
13.1 Monitoring  

Weekly meetings will be conducted with the team members during all stages of the study to 
review progress to date, any protocol deviations, data management, safety monitoring, and 
compliance.  
13.2 Scientific Advisory Board 
The Scientific Advisory Board will be comprised of PI, Co-Investigator, Project Manager, 
Biostatistician from the study two and 2 outside experts. The study team will provide a report to 
the scientific advisory board annually, and the board will discuss and make recommendations to 
support completion of scientific aims. As this will be a minimal risk study, this oversight is 
sufficient.  
14 PROTOCOL DEVIATIONS  
A trial related deviation is a departure from the ethically approved trial protocol or other trial 
document or process (e.g. consent process) or any applicable regulatory requirements. Any 
deviations from the protocol will be documented in a protocol deviation form and filed in the trial 
master file. The protocol deviations and completed forms will be presented to the PI and study 
team by the project coordinator during weekly meetings. The review will ensure any repetitive or 
single, but significant deviations be escalated to the IRB for assessment of whether a non-
compliance /deviation may be a potential Serious Breach and determine any necessary response. 
15 ETHICAL AND REGULATORY CONSIDERATIONS 
 
15.1 Participant Confidentiality 
To track participant outcomes across time while maintaining confidentiality, ID numbers 
will be used. A separate linking file will be maintained linking the IDs to the respondents' 
names. The surveys will be conducted using the mobile REDCap database, a password 
protected, firewalled database only accessible to the research team. Data will be collected 
using RedCap app. In case of computer problems, we will have paper copies of surveys 
available. All paper documentation will be maintained in locked files at UNC. 
15.2 Expenses and Benefits 
Participants will receive $195 in compensation for participation in data collection and 
intervention session attendance: $5 eligibility screening, $25 for baseline data collection, 
$15 for 6 month data collection, $20 for 12 month data collection, and $20 for 18 month 
data collection. Throughout the intervention, participants will receive a $15 cash incentive 
for attendance at Group Sessions 4, 8, 12, 16, 20, 24, and $20 at session 26.  
16 PUBLICATION POLICY 
The study PI is responsible for intellectual content on publications from the dataset collected for 
this study. Study PI should determine appropriate authorship and acknowledgements for all 
scientific publications. Institutional and funder policies should be adhered to. NHLBI should be 
acknowledged in all publications. 
17 ARCHIVING 
6 months after the main study outcomes paper is published, de-identified dataset will be available 
per institutional and federal guidelines. Data will be destroyed five years after the study 

publications are complete. For electronic data, we will follow accepted techniques to permanently 
delete files. This will include destruction of linkage files, transcriptions, data files, web-based 
database files, digital interviews and all other electronic files. All paper files will be shredded at 
that time. 
 
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