Heart DiseasesNCT04705779
The HARMONY Study: A Intervention to Reduce Cardiometabolic Risk in African American Women
A study testing HARMONY and Nutrition and Exercise Education (NEEW) in people with Heart Diseases and Stroke, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study will test whether a culturally-tailored nutrition and exercise intervention designed for African-American women will lead to sustained improvements in exercise and healthy eating through improvements in self-management mediators: mindfulness, stress management, positive reappraisal, self-regulation, and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Heart Diseases, Stroke, Pre-diabetes
- What is being tested?
- HARMONY and Nutrition and Exercise Education (NEEW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 7 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported African American or Black woman
- BMI= 25-39 kg/m^2 (confirmed at baseline assessment)
- At least one cardiometabolic risk factor:
- < 150 minutes of self-reported moderate to vigorous exercise
- History of gestational diabetes
- Parent or sibling with prediabetes or diabetes
Show all 16Show fewer
- Personal or family history of hypertension (=130/80)
- Prediabetes or impaired glucose metabolism (HgbA1c 5.7-6.5)
- Personal or family history of abnormal cholesterol levels
- At least 18 years of age
- Able to read/speak English
- Willing to attend scheduled classes, complete internet surveys and biomarker assessments
- Able/willing to engage in moderate to vigorous exercise
- Ambulatory
- Superwoman Schema Questionnaire score indicating at least moderate endorsement of one or more subscales (strength: 7; motional suppression: 7; resistance of vulnerability: 8; motivation to succeed: 7; or helping others: 10) or a total score of 20 or greater
- A Perceived Stress Scale-14 score of >5 or self-report at least "some" general stress.
Who cannot join
- Pregnant/anticipated pregnancy
- Substance use, mental health or medical condition that will prevent the ability to participate in the intervention
- Use of weight loss medication
- Current or recent (<6 months prior to enrollment) engagement in another weight loss or meditation program
- Impaired cognition (inability to follow and respond appropriately during screening).
- Diabetes diagnosis
Show all 9Show fewer
- Has a confirmed BMI lower than 25 or higher than 39
- Does not have access to a smartphone or computer with internet access
- Lives in the same household as someone who is currently in the study or was previously in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: The HARMONY Study: A Culturally-relevant, Randomized-controlled, Stress Management Intervention to Reduce Cardiometabolic Risk in African American Women
This study will test whether a culturally-tailored nutrition and exercise intervention designed for African-American women will lead to sustained improvements in exercise and healthy eating through improvements in self-management mediators: mindfulness, stress management, positive reappraisal, self-regulation, and self-efficacy.
Read the detailed description
Among all groups of women in the US, African American women (AAW) have the highest rates of death and disability from chronic cardiometabolic (CM) illnesses. Furthermore, AAW have inadequate engagement in exercise and are least successful at achieving and sustaining CM risk-reduction goals compared to all men and women of other racial/ethnic groups, despite participating in comprehensive lifestyle interventions. These alarming disparities are due in part to disproportionately high rates of psychological stress. A shortcoming of interventions with AAW is an inadequate focus on stress exposure, including gender and racialized stress, stress physiology, and stress-related barriers to healthy eating and exercise to reduce CM risk. In response, the HARMONY study is a randomized controlled trial to test a culturally-tailored nutrition and exercise intervention to manage stress, designed to help AAW build on their strengths to promote self-management and to reduce stress-related CM risk. Certain information about the interventions is not disclosed to protect the scientific integrity of the trial.
- Conditions
- Heart Diseases, Stroke, Pre-diabetes, Hypertension, Obesity, Overweight
- Being tested
- HARMONY, Nutrition and Exercise Education (NEEW)
- Keywords
- HARMONY
- Medical subject headings
- Heart Diseases, Stroke, Glucose Intolerance, Hypertension, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HARMONYBehavioural
The HARMONY intervention will be delivered over 8 every-other-week sessions and 6 monthly booster sessions. Each session will have three components; an exercise sampler, cool down and tailored education on cardiometabolic prevention and risk reductions.
Nutrition and Exercise Education (NEEW)Behavioural
The Nutrition and Exercise Workgroup (NEEW) group will be delivered over 8 every-other-week sessions and 6 monthly booster sessions. Each session will have three components; an exercise sampler, cool down and tailored education on cardiometabolic prevention and risk reductions.
| Study group | Role | What they receive |
|---|---|---|
| HARMONY | Experimental | Following screening, participation includes 8 regular sessions occurring over 4 months followed by 6 monthly booster sessions. Overall, study participation will last approximately 14 months. Receives: Behavioral: HARMONY |
| Nutrition and Exercise Education Workgroup (NEEW) | Active comparator | Following screening, participation includes 8 regular sessions occurring over 4 months followed by 6 monthly booster sessions. Overall, study participation will last approximately 14 months. Receives: Behavioral: Nutrition and Exercise Education (NEEW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Amount of Moderate to Vigorous Physical Activity
The participant's moderate to vigorous physical activity will be measured by triaxial accelerometry. Participants are instructed to wear the accelerometer for seven full days; the average number of minutes of MVPA per 24-hour period is computed. Results will be reported in minutes per day.
Measured: Baseline, 48 weeks after first group session
Change in the Dietary Risk Assessment Score
The participant's dietary intake will be assessed using the dietary risk assessment, which includes 54 items. The dietary risk assessment measures the healthiness of a participant's eating habits. Score ranges from 0 to 108, with higher scores associated with less healthy dietary intake.
Measured: Baseline, 48 weeks after first group session
Change in Veggie Meter Score
The participant's nutrition will be assessed using the veggie meter, which uses light reflectance spectroscopy to provide an estimated skin carotenoid composite score. Score ranges from 0 to 800, with higher scores associated with greater fruit and vegetable intake.
Measured: Baseline, 48 weeks after first group session
Secondary outcomes (9)
Change in BMI
The participant's BMI is calculated as weight (kg) divided by the square of height (m^2).
Measured: Baseline, 48 weeks after first group session
Change in Weight
The participants weight will be measured using a digital scale.
Measured: Baseline, 48 weeks after first group session
Change in Waist-to-Hip Ratio
The participant's waist to hip ratio is calculated by using the mean of two waist circumference measurements divided by mean of two hip circumference measurements. Waist circumference will be measured at the midpoint between the upper iliac crest and lower costal margin in the midaxillary line. Hip circumference will be measured at the maximum width of the buttocks or gluteo-femoral fold.
Measured: Baseline, 48 weeks after first group session
Change in Percent Body Fat
The participant's percent body fat is measured using lange skinfold calipers. The final measurement will be the mean of three measurements on the right side of the body.
Measured: Baseline, 48 weeks after first group session
Change in Blood Pressure (Systolic)
The participant's blood pressure is measured using an electronic sphygmomanometer. The final measurement will be the mean of three measurements.
Measured: Baseline, 48 weeks after first group session
Change in Blood Pressure (Diastolic)
The participant's blood pressure is measured using an electronic sphygmomanometer. The final measurement will be the mean of three measurements.
Measured: Baseline, 48 weeks after first group session
Change in High Sensitivity C-Reactive Protein Amount
The participant's high sensitivity C-reactive protein levels will be obtained via phlebotomy. C-Reactive Protein is an inflammatory biomarker, and indicative of cardiovascular risk. Data will be log-transformed, and the units will be log-(ng/mL).
Measured: Baseline, 48 weeks after first group session
Change in IL-6
The participant's IL-6 levels will be obtained via phlebotomy. IL-6 is an inflammatory biomarker, and indicative of cardiovascular risk. Data will be log-transformed, and the units will be log-(pg/mL).
Measured: Baseline, 48 weeks after first group session
Change in Glycosylated Hemoglobin (HbA1c)
Participant's glycosylated hemoglobin levels will be obtained via phlebotomy. Glycosylated hemoglobin amount is indicative of cardiovascular risk.
Measured: Baseline, 48 weeks after first group session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start20 May 2021
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Cheryl Giscombe, PhD, RN, PMHNP-BC, FAAN, Principal investigator, The University of North Carolina at Chapel Hill, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705779
- Sponsor's protocol ID
- 20-2193
- Other IDs
- 1R01MD015388-01A1
- Status last verified
- Mar 2025
- First submitted
- 8 Jan 2021
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared up 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 UNC.
Publications
Woods-Giscombe CL, Gaylord S, Bradford A, Vines S, Eason K, Smith R, Addo-Mensah D, Lackey C, Dsouza V, Sheffield-Abdullah K, Day T, Green-Scott K, Chilcoat A, Peace-Coard A, Chalmers L, Evenson KR, Samuel-Hodge C, Lewis TT, Crandell J, Corbie G, Faurot K. Protocol of the HARMONY study: A culturally relevant, randomized-controlled, stress management intervention to reduce cardiometabolic risk in African American women. Contemp Clin Trials. 2024 Nov;146:107604. doi: 10.1016/j.cct.2024.107604. Epub 2024 Jun 10.
PubMed 38866096
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HARMONY Study: A Culturally-relevant, Randomized-controlled, Stress Management Intervention to Reduce Cardiometabolic Risk in African American Women
- ClinicalTrials.gov ID
- NCT04705779
- Acronym / sponsor ID
- 20-2193
- Conditions
- Heart Diseases, Stroke, Pre-diabetes, Hypertension, Obesity, Overweight
- Keywords
- HARMONY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 20 May 2021 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Posted 29 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test whether a culturally-tailored nutrition and exercise intervention designed for African-American women will lead to sustained improvements in exercise and healthy eating through improvements in self-management mediators: mindfulness, stress management, positive reappraisal, self-regulation, and self-efficacy.
Detailed description
Among all groups of women in the US, African American women (AAW) have the highest rates of death and disability from chronic cardiometabolic (CM) illnesses. Furthermore, AAW have inadequate engagement in exercise and are least successful at achieving and sustaining CM risk-reduction goals compared to all men and women of other racial/ethnic groups, despite participating in comprehensive lifestyle interventions. These alarming disparities are due in part to disproportionately high rates of psychological stress. A shortcoming of interventions with AAW is an inadequate focus on stress exposure, including gender and racialized stress, stress physiology, and stress-related barriers to healthy eating and exercise to reduce CM risk. In response, the HARMONY study is a randomized controlled trial to test a culturally-tailored nutrition and exercise intervention to manage stress, designed to help AAW build on their strengths to promote self-management and to reduce stress-related CM risk. Certain information about the interventions is not disclosed to protect the scientific integrity of the trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HARMONY | Experimental | Behavioral: HARMONYFollowing screening, participation includes 8 regular sessions occurring over 4 months followed by 6 monthly booster sessions. Overall, study participation will last approximately 14 months. |
| Nutrition and Exercise Education Workgroup (NEEW) | Active comparator | Behavioral: Nutrition and Exercise Education (NEEW)Following screening, participation includes 8 regular sessions occurring over 4 months followed by 6 monthly booster sessions. Overall, study participation will last approximately 14 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Self-reported African American or Black woman
- BMI= 25-39 kg/m^2 (confirmed at baseline assessment)
- At least one cardiometabolic risk factor:
- < 150 minutes of self-reported moderate to vigorous exercise
- History of gestational diabetes
Key exclusion criteria (9 listed)
- Pregnant/anticipated pregnancy
- Substance use, mental health or medical condition that will prevent the ability to participate in the intervention
- Use of weight loss medication
- Current or recent (<6 months prior to enrollment) engagement in another weight loss or meditation program
- Impaired cognition (inability to follow and respond appropriately during screening).
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 |
|---|---|---|
| HARMONYThe HARMONY intervention will be delivered over 8 every-other-week sessions and 6 monthly booster sessions. Each session will have three components; an exercise sampler, cool down and tailored education on cardiometabolic prevention and risk reductions. | Behavioural | HARMONY |
| Nutrition and Exercise Education (NEEW)The Nutrition and Exercise Workgroup (NEEW) group will be delivered over 8 every-other-week sessions and 6 monthly booster sessions. Each session will have three components; an exercise sampler, cool down and tailored education on cardiometabolic prevention and risk reductions. | Behavioural | Nutrition and Exercise Education Workgroup (NEEW) |
Primary outcome
Change in Amount of Moderate to Vigorous Physical Activity
Time frame: Baseline, 48 weeks after first group session
The participant's moderate to vigorous physical activity will be measured by triaxial accelerometry. Participants are instructed to wear the accelerometer for seven full days; the average number of minutes of MVPA per 24-hour period is computed. Results will be reported in minutes per day.
Change in the Dietary Risk Assessment Score
Time frame: Baseline, 48 weeks after first group session
The participant's dietary intake will be assessed using the dietary risk assessment, which includes 54 items. The dietary risk assessment measures the healthiness of a participant's eating habits. Score ranges from 0 to 108, with higher scores associated with less healthy dietary intake.
Change in Veggie Meter Score
Time frame: Baseline, 48 weeks after first group session
The participant's nutrition will be assessed using the veggie meter, which uses light reflectance spectroscopy to provide an estimated skin carotenoid composite score. Score ranges from 0 to 800, with higher scores associated with greater fruit and vegetable intake.
9 secondary outcomes
Change in BMI
Time frame: Baseline, 48 weeks after first group session
Change in Weight
Time frame: Baseline, 48 weeks after first group session
Change in Waist-to-Hip Ratio
Time frame: Baseline, 48 weeks after first group session
Change in Percent Body Fat
Time frame: Baseline, 48 weeks after first group session
Change in Blood Pressure (Systolic)
Time frame: Baseline, 48 weeks after first group session
Change in Blood Pressure (Diastolic)
Time frame: Baseline, 48 weeks after first group session
Change in High Sensitivity C-Reactive Protein Amount
Time frame: Baseline, 48 weeks after first group session
Change in IL-6
Time frame: Baseline, 48 weeks after first group session
Change in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, 48 weeks after first group session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38866096Woods-Giscombe CL, Gaylord S, Bradford A, Vines S, Eason K, Smith R, Addo-Mensah D, Lackey C, Dsouza V, Sheffield-Abdullah K, Day T, Green-Scott K, Chilcoat A, Peace-Coard A, Chalmers L, Evenson KR, Samuel-Hodge C, Lewis TT, Crandell J, Corbie G, Faurot K. Protocol of the HARMONY study: A culturally relevant, randomized-controlled, stress management intervention to reduce cardiometabolic risk in African American women. Contemp Clin Trials. 2024 Nov;146:107604. doi: 10.1016/j.cct.2024.107604. Epub 2024 Jun 10.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared up 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 UNC.
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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.
Cheryl Giscombe, PhD, RN, PMHNP-BC, FAAN principal investigator
The University of North Carolina at Chapel Hill, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HARMONY and Nutrition and Exercise Education (NEEW) in people with Heart Diseases and Stroke, run by University of North Carolina, Chapel Hill at 1 site 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 16 inclusion and 9 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 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Amount of Moderate to Vigorous Physical Activity (time frame: Baseline, 48 weeks after first group session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04705779, which also lists 1 linked publication.
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 29 Jan 2026.