Cardiovascular DiseasesCo-LEARNNCT06730633
Collaborate and Leverage Evidence in African American Rural Network
A study testing Heart Matters in people with Cardiovascular Diseases, run by University of North Carolina, Chapel Hill at 9 sites in United States.
Trial summary
The goal of this non-randomized, propensity-matched-controlled study is to assess the effectiveness of the Heart Matters evidence-based program -- previously evaluated for feasibility and efficacy in NCT02707432 -- in improving cardiovascular health outcomes (change in systolic and diastolic blood pressure, primary… Read more about this study
- Who is it for?
- Ages 18 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
- 173 participants
- Where
- 9 sitesUnited States
- Study dates
- 22 Feb 2025to 17 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identify as Black or African American
- Reside in rural, eastern North Carolina
- Self-report at least one cardiovascular disease risk factor, such as pre-diabetes, pre-hypertension or stage one hypertension, obesity, or family history of early heart disease
Who cannot join
- Evidence of active or unstable cardiovascular disease
- Cognitive impairment that limits informed consent
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
A Better Chance, A Better Community
Enfield, North Carolina, 27823
The Mercer Foundation, Inc.
Nashville, North Carolina, 27856
Marks Chapel Baptist Church
Rocky Mount, North Carolina, 27801
Thorne's Chapel Missionary Baptist Church
Rocky Mount, North Carolina, 27801
Truth Tabernacle Ministries
Rocky Mount, North Carolina, 27801
Girls Making the Grade
Rocky Mount, North Carolina, 27804
Carolina Hierarchy of Needs
Spring Hope, North Carolina, 27882
St. James United Holy Church
Stantonsburg, North Carolina, 27883
Warren County Health Department
Warrenton, North Carolina, 27537
About this study
Official title: Implementation of Heart Matters Evidence-based Program
The goal of this non-randomized, propensity-matched-controlled study is to assess the effectiveness of the Heart Matters evidence-based program -- previously evaluated for feasibility and efficacy in NCT02707432 -- in improving cardiovascular health outcomes (change in systolic and diastolic blood pressure, primary outcomes) when implemented by community-based facilitators.
Read the detailed description
The research team will use a non-randomized, propensity-matched-controlled design to evaluate the effectiveness of the Heart Matters evidence-based program -- previously evaluated for feasibility and efficacy under NCT02707432 -- in improving cardiovascular health outcomes when scaled in multiple rural, eastern North Carolina counties and implemented by community-based facilitators.
This study aims to recruit 210 participants, 70 of whom will be propensity-score-matched with participants from NCT02707432. Propensity-score-matching will allow for flexibility in recruitment, statistical rigor, and resource efficiency. The research team hypothesizes that matched participants in the present study will show significant improvements in health outcomes (systolic blood pressure, diastolic blood pressure) compared to the matched NCT02707432 controls.
- Conditions
- Cardiovascular Diseases
- Being tested
- Heart Matters
- Keywords
- Heart health, Behavioral modification, Community-based participatory research
- 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 a lifestyle modification intervention guided by the theory of planned behavior. Designed to mitigate cardiovascular disease risk factors, the program strives to help participants consume nutritious foods, engage in a more active lifestyle, lose weight and lower their systolic or diastolic blood pressure. Lifestyle modifications can include weight loss, a reduction in percent calorie fat consumption and total sodium intake, improving diet and increasing physical activity, and reducing daily alcoholic beverage consumption.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This group will receive the Heart Matters intervention, delivered by community-based facilitators. All participants consenting to the present study will be assigned to this arm. Receives: Behavioral: Heart Matters |
| Propensity-matched Control Group (Retrospective) | Active comparator | This group received the Heart Matters intervention, delivered by researchers, under NCT02707432. Receives: Behavioral: Heart Matters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from Baseline, Systolic Blood Pressure
Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor. Reporting will compare participants in the present study with propensity-score-matched controls.
Measured: Baseline, 12 Months
Mean change from Baseline, Diastolic Blood Pressure
Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor. Reporting will compare participants in the present study with propensity-score-matched controls.
Measured: Baseline, 12 Months
Secondary outcomes (34)
Number of Participants with Personal History of Cardiovascular Disease
Personal history of cardiovascular disease is measured via self-report at baseline using an adapted item from My Personal Health Record (MyPHR). Personal history of cardiovascular disease is defined as history of diabetes, heart surgery, high blood cholesterol, high blood pressure, pain or pressure in chest, palpitations, stroke, or other heart condition (including heart attack).
Measured: Baseline
Number of Participants with Family History of Cardiovascular Disease
Family history of cardiovascular disease is measured via self-report using an adapted item from the Women's Health Initiative. Family history of cardiovascular disease is defined as having a parent, full-blooded sibling, or child who has ever had a heart condition, such as heart attack, high blood pressure, or stroke.
Measured: Baseline
Mean Systolic Blood Pressure in mmHg
Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor.
Measured: Baseline, 6 Months
Mean Diastolic Blood Pressure in mmHg
Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor.
Measured: Baseline, 6 Months
Mean Body-mass Index
Body-mass index (BMI) will be calculated as weight (pounds) * 703 / height^2 (inches).
Measured: Baseline, 6 Months, 12 Months
Mean Weight in Pounds
Weight will be measured via a digital scale.
Measured: Baseline, 6 Months, 12 Months
Mean Waist Circumference in Centimeters
Waist circumference will be measured using inelastic tape.
Measured: Baseline, 6 Months, 12 Months
Mean Total Cholesterol in mg/dL
Total cholesterol is measured via blood sample using a Cholestech LDX analyzer.
Measured: Baseline, 6 Months, 12 Months
Mean High-density Lipoprotein (HDL) Cholesterol in mg/dL
HDL cholesterol is measured via blood sample using a Cholestech LDX analyzer.
Measured: Baseline, 6 Months, 12 Months
Mean Low-density Lipoprotein (LDL) Cholesterol in mg/dL
LDL cholesterol is measured via blood sample using a Cholestech LDX analyzer.
Measured: Baseline, 6 Months, 12 Months
Mean Blood Triglycerides in mg/dL
Blood triglycerides are measured via blood sample using a Cholestech LDX analyzer.
Measured: Baseline, 6 Months, 12 Months
Mean Glycated Hemoglobin (A1C) Score
A1C is measured via blood sample using A1CNow+ test kits.
Measured: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Smoking Status
Smoking status is measured via self-report using excerpted items from wave 1 of the Population Assessment of Tobacco and Health Study. Reporting will include number of participants endorsing ever having smoked a cigarette and (among participants who have endorse ever having smoked) numbers of participants endorsing now smoking every day, some days, or not at all.
Measured: Baseline, 6 Months, 12 Months
Mean Healthy Days
Healthy Days measured via self report using the Center for Disease Control (CDC)'s 4-item Healthy Days Core Module (HRQOL-4) with a look-back period of 30 days. HRQOL-4 scores can range from 0 to 30, with 30 indicating maximum number of healthy days.
Measured: Baseline, 6 Months, 12 Months
Mean Heart Disease Fact Questionnaire Score
Heart disease knowledge is measured via self-report using the 25-item Heart Disease Fact Questionnaire (HDFQ). HDFQ scores can range from 0 to 25, with higher scores indicating greater knowledge of heart disease.
Measured: Baseline, 6 Months, 12 Months
Mean University of Rhode Island Change Assessment Score
Readiness for behavioral change is measured via self-report using the 32-item University of Rhode Island Change Assessment (URICA). URICA scores can range from -2 to +14, with higher scores indicating greater levels of readiness to change.
Measured: Baseline, 6 Months, 12 Months
Mean Perceived Stress Scale Score
Perceived stress is measured via self-report using the 10-item Perceived Stress Scale (PSS). PSS scores can range from 0 to 40, with higher scores indicating higher levels of perceived stress.
Measured: Baseline, 6 Months, 12 Months
Mean Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) Score
Alcohol use is measured via self-report using the 3-item Alcohol Use Disorders Identification Test - Consumption (AUDIT-C). AUDIT-C scores can range from 0 to 12, with higher scores indicating greater of drinking quantity and/or frequency.
Measured: Baseline, 6 Months, 12 Months
Mean Minutes of Light, Moderate, and Vigorous Leisure-Time Physical Activity
Minutes of light, moderate, and vigorous leisure-time physical activity is measured via self-report using an English-language version of Registre Gironí del Cor (REGICOR) with a look-back period of one month.
Measured: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Sweetened Fruit Drinks
Dietary intake of sweetened fruit drinks is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.
Measured: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of 100% Pure Fruit Juice
Dietary intake of 100% pure fruit juice is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.
Measured: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Soda
Dietary intake of soda is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.
Measured: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Water
Dietary intake of water is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.
Measured: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Fruit
Dietary intake of fruit is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.
Measured: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Vegetables (Excluding Potatoes)
Dietary intake of vegetables (excluding potatoes) is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.
Measured: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Frozen and Fast Food
Dietary intake of frozen and fast food is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.
Measured: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Processed Meat
Dietary intake of processed meat is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.
Measured: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Whole Grains
Dietary intake of whole grains is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.
Measured: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Candy, Desserts, and Chocolate
Dietary intake of candy, desserts, and chocolate is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.
Measured: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Chips
Dietary intake of chips is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.
Measured: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Sugary Cereals
Dietary intake of sugary cereals is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.
Measured: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Fish
Dietary intake of fish is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.
Measured: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Nuts and Seeds
Dietary intake of nuts and seeds is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.
Measured: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Eggs
Dietary intake of eggs is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.
Measured: Baseline, 6 Months, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start22 Feb 2025
- Primary completion14 Aug 2026
- Study completion17 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Non-randomized, propensity-matched-controlled trial. Specifically, 70 participants from the present study will be propensity-matched with 70 participants from NCT02707432.
- Masking
- None (open label)
- Enrolment
- 173 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), Project Momentum, Inc., James McFarlin Community Development, Inc., Opportunities Industrialization Center, Inc.
- Responsible party
- Sponsor
- Investigators
- Gaurav Dave, MBBS, DrPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730633
- Sponsor's protocol ID
- 21-1366
- Other IDs
- 5R01HL157255
- Acronym
- Co-LEARN
- Status last verified
- Aug 2026
- First submitted
- 9 Dec 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with The University of North Carolina at Chapel Hill.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Heart Matters Evidence-based Program
- ClinicalTrials.gov ID
- NCT06730633
- Acronym / sponsor ID
- Co-LEARN / 21-1366
- Conditions
- Cardiovascular Diseases
- Keywords
- Heart health, Behavioral modification, Community-based participatory research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Project Momentum, Inc., James McFarlin Community Development, Inc., Opportunities Industrialization Center, Inc.
- Study start
- 22 Feb 2025 (actual)
- Primary completion
- 14 Aug 2026 (actual)
- Study completion
- 17 Aug 2026 (actual)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this non-randomized, propensity-matched-controlled study is to assess the effectiveness of the Heart Matters evidence-based program -- previously evaluated for feasibility and efficacy in NCT02707432 -- in improving cardiovascular health outcomes (change in systolic and diastolic blood pressure, primary outcomes) when implemented by community-based facilitators.
Detailed description
The research team will use a non-randomized, propensity-matched-controlled design to evaluate the effectiveness of the Heart Matters evidence-based program -- previously evaluated for feasibility and efficacy under NCT02707432 -- in improving cardiovascular health outcomes when scaled in multiple rural, eastern North Carolina counties and implemented by community-based facilitators.
This study aims to recruit 210 participants, 70 of whom will be propensity-score-matched with participants from NCT02707432. Propensity-score-matching will allow for flexibility in recruitment, statistical rigor, and resource efficiency. The research team hypothesizes that matched participants in the present study will show significant improvements in health outcomes (systolic blood pressure, diastolic blood pressure) compared to the matched NCT02707432 controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized, propensity-matched-controlled trial. Specifically, 70 participants from the present study will be propensity-matched with 70 participants from NCT02707432.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Heart MattersThis group will receive the Heart Matters intervention, delivered by community-based facilitators. All participants consenting to the present study will be assigned to this arm. |
| Propensity-matched Control Group (Retrospective) | Active comparator | Behavioral: Heart MattersThis group received the Heart Matters intervention, delivered by researchers, under NCT02707432. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Identify as Black or African American
- Reside in rural, eastern North Carolina
- Self-report at least one cardiovascular disease risk factor, such as pre-diabetes, pre-hypertension or stage one hypertension, obesity, or family history of early heart disease
Key exclusion criteria (2 listed)
- Evidence of active or unstable cardiovascular disease
- 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: PREMIERHeart Matters is a lifestyle modification intervention guided by the theory of planned behavior. Designed to mitigate cardiovascular disease risk factors, the program strives to help participants consume nutritious foods, engage in a more active lifestyle, lose weight and lower their systolic or diastolic blood pressure. Lifestyle modifications can include weight loss, a reduction in percent calorie fat consumption and total sodium intake, improving diet and increasing physical activity, and reducing daily alcoholic beverage consumption. | Behavioural | Intervention Group, Propensity-matched Control Group (Retrospective) |
Primary outcome
Mean change from Baseline, Systolic Blood Pressure
Time frame: Baseline, 12 Months
Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor. Reporting will compare participants in the present study with propensity-score-matched controls.
Mean change from Baseline, Diastolic Blood Pressure
Time frame: Baseline, 12 Months
Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor. Reporting will compare participants in the present study with propensity-score-matched controls.
34 secondary outcomes
Number of Participants with Personal History of Cardiovascular Disease
Time frame: Baseline
Number of Participants with Family History of Cardiovascular Disease
Time frame: Baseline
Mean Systolic Blood Pressure in mmHg
Time frame: Baseline, 6 Months
Mean Diastolic Blood Pressure in mmHg
Time frame: Baseline, 6 Months
Mean Body-mass Index
Time frame: Baseline, 6 Months, 12 Months
Mean Weight in Pounds
Time frame: Baseline, 6 Months, 12 Months
Mean Waist Circumference in Centimeters
Time frame: Baseline, 6 Months, 12 Months
Mean Total Cholesterol in mg/dL
Time frame: Baseline, 6 Months, 12 Months
Mean High-density Lipoprotein (HDL) Cholesterol in mg/dL
Time frame: Baseline, 6 Months, 12 Months
Mean Low-density Lipoprotein (LDL) Cholesterol in mg/dL
Time frame: Baseline, 6 Months, 12 Months
Mean Blood Triglycerides in mg/dL
Time frame: Baseline, 6 Months, 12 Months
Mean Glycated Hemoglobin (A1C) Score
Time frame: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Smoking Status
Time frame: Baseline, 6 Months, 12 Months
Mean Healthy Days
Time frame: Baseline, 6 Months, 12 Months
Mean Heart Disease Fact Questionnaire Score
Time frame: Baseline, 6 Months, 12 Months
Mean University of Rhode Island Change Assessment Score
Time frame: Baseline, 6 Months, 12 Months
Mean Perceived Stress Scale Score
Time frame: Baseline, 6 Months, 12 Months
Mean Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) Score
Time frame: Baseline, 6 Months, 12 Months
Mean Minutes of Light, Moderate, and Vigorous Leisure-Time Physical Activity
Time frame: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Sweetened Fruit Drinks
Time frame: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of 100% Pure Fruit Juice
Time frame: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Soda
Time frame: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Water
Time frame: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Fruit
Time frame: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Vegetables (Excluding Potatoes)
Time frame: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Frozen and Fast Food
Time frame: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Processed Meat
Time frame: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Whole Grains
Time frame: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Candy, Desserts, and Chocolate
Time frame: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Chips
Time frame: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Sugary Cereals
Time frame: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Fish
Time frame: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Nuts and Seeds
Time frame: Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Eggs
Time frame: Baseline, 6 Months, 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with The University of North Carolina at Chapel Hill.
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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.
Gaurav Dave, MBBS, DrPH principal investigator
University of North Carolina, Chapel Hill
9 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 9 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 3 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 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change from Baseline, Systolic Blood Pressure (time frame: Baseline, 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2026.