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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MD015388-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HARMONY | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline, 48 weeks after first group session |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI | The participant's BMI is calculated as weight (kg) divided by the square of height (m^2). | Baseline, 48 weeks after first group session |
| Change in Weight | The participants weight will be measured using a digital scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl Giscombe, PhD, RN, PMHNP-BC, FAAN | The University of North Carolina at Chapel Hill, School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38866096 | Derived | 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. |
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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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The data will become available per NIH policy, which is no later than the acceptance for publication of the main findings from the dataset.
All researchers who desire to access the individual participant data must enter into a data-sharing agreement.
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Of 175 participants who signed informed consent, 173 started the study and received an intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | HARMONY | 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. HARMONY: 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. |
| FG001 | Nutrition and Exercise Education Workgroup (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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HARMONY | 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. HARMONY: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in 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. | Participants who wore the accelerometer for at least 8 hours at each timepoint. | Posted | Mean | Standard Deviation | minutes/day | Baseline, 48 weeks after first group session |
|
From the time of randomization until study completion, up to 48 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HARMONY | 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. HARMONY: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Broken toes subsequent to prior condition | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cheryl Giscombe, PhD | University of North Carolina at Chapel Hill | 919-966-9905 | cheryl.giscombe@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2022 | Dec 8, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 27, 2022 | Mar 11, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D020521 | Stroke |
| D018149 | Glucose Intolerance |
| D006973 | Hypertension |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C087247 | Harmony Hard |
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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| Nutrition and Exercise Education (NEEW) | Behavioral | 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. |
|
| 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. | 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. | 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. | 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. | 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). | 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). | 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. | Baseline, 48 weeks after first group session |
| BG001 | Nutrition and Exercise Education Workgroup (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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Nutrition and Exercise Education Workgroup (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. 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. |
|
|
| Primary | 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. | Participants who completed the dietary risk assessment at baseline and 48 weeks. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 48 weeks after first group session |
|
|
|
| Primary | 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. | Participants who provided Veggie meter data at at baseline and 48 weeks. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 48 weeks after first group session |
|
|
|
| Secondary | Change in BMI | The participant's BMI is calculated as weight (kg) divided by the square of height (m^2). | Participants who provided BMI data at baseline and 48 weeks. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, 48 weeks after first group session |
|
|
|
| Secondary | Change in Weight | The participants weight will be measured using a digital scale. | Participants who provided weight data at baseline and 48 weeks. | Posted | Mean | Standard Deviation | kg | Baseline, 48 weeks after first group session |
|
|
|
| Secondary | 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. | Participants who provided waist and hip measurements at baseline and 48 weeks. | Posted | Mean | Standard Deviation | unitless ratio | Baseline, 48 weeks after first group session |
|
|
|
| Secondary | 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. | Participants who provided percent body fat data at baseline and 48 weeks. | Posted | Mean | Standard Deviation | percent of total body mass | Baseline, 48 weeks after first group session |
|
|
|
| Secondary | 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. | Participants who provided blood pressure data at baseline and 48 weeks. | Posted | Mean | Standard Deviation | mm Hg | Baseline, 48 weeks after first group session |
|
|
|
| Secondary | 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. | Participants who provided blood pressure at baseline and 48 weeks. | Posted | Mean | Standard Deviation | mm Hg | Baseline, 48 weeks after first group session |
|
|
|
| Secondary | 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). | Participants who provided blood samples that were successfully assayed for CRP at baseline and 48 weeks. | Posted | Mean | Standard Deviation | log(ng/mL) | Baseline, 48 weeks after first group session |
|
|
|
| Secondary | 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). | Participants who provided blood samples that were successfully assayed for Il-6 at baseline and 48 weeks. | Posted | Mean | Standard Deviation | log(pg/mL) | Baseline, 48 weeks after first group session |
|
|
|
| Secondary | Change in Glycosylated Hemoglobin (HbA1c) | Participant's glycosylated hemoglobin levels will be obtained via phlebotomy. Glycosylated hemoglobin amount is indicative of cardiovascular risk. | Participants who provided fingerstick data at baseline and 48 weeks | Posted | Mean | Standard Deviation | percent of hemoglobin | Baseline, 48 weeks after first group session |
|
|
|
| 0 |
| 87 |
| 0 |
| 87 |
| 1 |
| 87 |
| EG001 | Nutrition and Exercise Education Workgroup (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. 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. | 0 | 86 | 0 | 86 | 0 | 86 |
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003710 | Demography |
| D011154 | Population Characteristics |