Trial Outcomes & Findings for The HARMONY Study: A Intervention to Reduce Cardiometabolic Risk in African American Women (NCT NCT04705779)
NCT ID: NCT04705779
Last Updated: 2026-01-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
175 participants
Primary outcome timeframe
Baseline, 48 weeks after first group session
Results posted on
2026-01-29
Participant Flow
Of 175 participants who signed informed consent, 173 started the study and received an intervention.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
86
|
|
Overall Study
COMPLETED
|
49
|
43
|
|
Overall Study
NOT COMPLETED
|
38
|
43
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The HARMONY Study: A Intervention to Reduce Cardiometabolic Risk in African American Women
Baseline characteristics by cohort
| Measure |
HARMONY
n=87 Participants
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.
|
Nutrition and Exercise Education Workgroup (NEEW)
n=86 Participants
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.
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 15.2 • n=35 Participants
|
48.6 years
STANDARD_DEVIATION 14.6 • n=4328 Participants
|
49.2 years
STANDARD_DEVIATION 14.8 • n=8687 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=35 Participants
|
86 Participants
n=4328 Participants
|
173 Participants
n=8687 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
Black and Non-Hispanic
|
72 Participants
n=35 Participants
|
71 Participants
n=4328 Participants
|
143 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
Black and Hispanic
|
5 Participants
n=35 Participants
|
2 Participants
n=4328 Participants
|
7 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
African and Non-Hispanic
|
2 Participants
n=35 Participants
|
4 Participants
n=4328 Participants
|
6 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
Black and West Indian or Caribbean, and Non-Hispanic
|
4 Participants
n=35 Participants
|
4 Participants
n=4328 Participants
|
8 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
Black and African, and Non-Hispanic
|
3 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
3 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
Black and West Indian or Caribbean and Native American, and Non-Hispanic
|
0 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
Black and Native American ,Black and West Indian or Caribbean, and Non-Hispanic
|
1 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
4 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
Black, Native American, and Creole, and Non-Hispanic
|
0 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
|
Region of Enrollment
United States
|
87 Participants
n=35 Participants
|
86 Participants
n=4328 Participants
|
173 Participants
n=8687 Participants
|
PRIMARY outcome
Timeframe: Baseline, 48 weeks after first group sessionPopulation: Participants who wore the accelerometer for at least 8 hours at each timepoint.
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.
Outcome measures
| Measure |
Nutrition and Exercise Education Workgroup (NEEW)
n=33 Participants
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.
|
HARMONY
n=41 Participants
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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|---|---|---|
|
Change in Amount of Moderate to Vigorous Physical Activity
|
-11.24 minutes/day
Standard Deviation 58.40
|
-5.89 minutes/day
Standard Deviation 63.56
|
PRIMARY outcome
Timeframe: Baseline, 48 weeks after first group sessionPopulation: Participants who completed the dietary risk assessment at baseline and 48 weeks.
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.
Outcome measures
| Measure |
Nutrition and Exercise Education Workgroup (NEEW)
n=32 Participants
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.
|
HARMONY
n=41 Participants
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.
|
|---|---|---|
|
Change in the Dietary Risk Assessment Score
|
2.54 score on a scale
Standard Deviation 4.31
|
0.45 score on a scale
Standard Deviation 4.32
|
PRIMARY outcome
Timeframe: Baseline, 48 weeks after first group sessionPopulation: Participants who provided Veggie meter data at at baseline and 48 weeks.
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.
Outcome measures
| Measure |
Nutrition and Exercise Education Workgroup (NEEW)
n=39 Participants
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.
|
HARMONY
n=47 Participants
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.
|
|---|---|---|
|
Change in Veggie Meter Score
|
9.38 score on a scale
Standard Deviation 94.17
|
19.85 score on a scale
Standard Deviation 81.85
|
SECONDARY outcome
Timeframe: Baseline, 48 weeks after first group sessionPopulation: Participants who provided BMI data at baseline and 48 weeks.
The participant's BMI is calculated as weight (kg) divided by the square of height (m\^2).
Outcome measures
| Measure |
Nutrition and Exercise Education Workgroup (NEEW)
n=40 Participants
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.
|
HARMONY
n=48 Participants
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.
|
|---|---|---|
|
Change in BMI
|
-.56 kg/m^2
Standard Deviation 2.07
|
-.09 kg/m^2
Standard Deviation 1.83
|
SECONDARY outcome
Timeframe: Baseline, 48 weeks after first group sessionPopulation: Participants who provided weight data at baseline and 48 weeks.
The participants weight will be measured using a digital scale.
Outcome measures
| Measure |
Nutrition and Exercise Education Workgroup (NEEW)
n=40 Participants
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.
|
HARMONY
n=48 Participants
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.
|
|---|---|---|
|
Change in Weight
|
-2.08 kg
Standard Deviation 5.53
|
-1 kg
Standard Deviation 4.54
|
SECONDARY outcome
Timeframe: Baseline, 48 weeks after first group sessionPopulation: Participants who provided waist and hip measurements at baseline and 48 weeks.
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.
Outcome measures
| Measure |
Nutrition and Exercise Education Workgroup (NEEW)
n=38 Participants
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.
|
HARMONY
n=48 Participants
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.
|
|---|---|---|
|
Change in Waist-to-Hip Ratio
|
0 unitless ratio
Standard Deviation 0.09
|
.05 unitless ratio
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Baseline, 48 weeks after first group sessionPopulation: Participants who provided percent body fat data at baseline and 48 weeks.
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.
Outcome measures
| Measure |
Nutrition and Exercise Education Workgroup (NEEW)
n=9 Participants
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.
|
HARMONY
n=9 Participants
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.
|
|---|---|---|
|
Change in Percent Body Fat
|
-.62 percent of total body mass
Standard Deviation 2.39
|
1.23 percent of total body mass
Standard Deviation 4.25
|
SECONDARY outcome
Timeframe: Baseline, 48 weeks after first group sessionPopulation: Participants who provided blood pressure data at baseline and 48 weeks.
The participant's blood pressure is measured using an electronic sphygmomanometer. The final measurement will be the mean of three measurements.
Outcome measures
| Measure |
Nutrition and Exercise Education Workgroup (NEEW)
n=34 Participants
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.
|
HARMONY
n=45 Participants
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.
|
|---|---|---|
|
Change in Blood Pressure (Systolic)
|
-1.44 mm Hg
Standard Deviation 22.28
|
3.58 mm Hg
Standard Deviation 15.17
|
SECONDARY outcome
Timeframe: Baseline, 48 weeks after first group sessionPopulation: Participants who provided blood pressure at baseline and 48 weeks.
The participant's blood pressure is measured using an electronic sphygmomanometer. The final measurement will be the mean of three measurements.
Outcome measures
| Measure |
Nutrition and Exercise Education Workgroup (NEEW)
n=34 Participants
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.
|
HARMONY
n=45 Participants
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.
|
|---|---|---|
|
Change in Blood Pressure (Diastolic)
|
-2.00 mm Hg
Standard Deviation 10.37
|
0.29 mm Hg
Standard Deviation 9.65
|
SECONDARY outcome
Timeframe: Baseline, 48 weeks after first group sessionPopulation: Participants who provided blood samples that were successfully assayed for CRP at baseline and 48 weeks.
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).
Outcome measures
| Measure |
Nutrition and Exercise Education Workgroup (NEEW)
n=37 Participants
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.
|
HARMONY
n=38 Participants
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.
|
|---|---|---|
|
Change in High Sensitivity C-Reactive Protein Amount
|
-0.450 log(ng/mL)
Standard Deviation 0.860
|
-0.784 log(ng/mL)
Standard Deviation 0.723
|
SECONDARY outcome
Timeframe: Baseline, 48 weeks after first group sessionPopulation: Participants who provided blood samples that were successfully assayed for Il-6 at baseline and 48 weeks.
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).
Outcome measures
| Measure |
Nutrition and Exercise Education Workgroup (NEEW)
n=34 Participants
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.
|
HARMONY
n=38 Participants
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.
|
|---|---|---|
|
Change in IL-6
|
0.819 log(pg/mL)
Standard Deviation 1.661
|
0.155 log(pg/mL)
Standard Deviation 0.670
|
SECONDARY outcome
Timeframe: Baseline, 48 weeks after first group sessionPopulation: Participants who provided fingerstick data at baseline and 48 weeks
Participant's glycosylated hemoglobin levels will be obtained via phlebotomy. Glycosylated hemoglobin amount is indicative of cardiovascular risk.
Outcome measures
| Measure |
Nutrition and Exercise Education Workgroup (NEEW)
n=40 Participants
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.
|
HARMONY
n=47 Participants
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.
|
|---|---|---|
|
Change in Glycosylated Hemoglobin (HbA1c)
|
-.03 percent of hemoglobin
Standard Deviation 0.44
|
-.06 percent of hemoglobin
Standard Deviation 0.61
|
Adverse Events
Nutrition and Exercise Education Workgroup (NEEW)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HARMONY
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nutrition and Exercise Education Workgroup (NEEW)
n=86 participants at risk
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.
|
HARMONY
n=87 participants at risk
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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Broken toes subsequent to prior condition
|
0.00%
0/86 • From the time of randomization until study completion, up to 48 weeks.
|
1.1%
1/87 • Number of events 1 • From the time of randomization until study completion, up to 48 weeks.
|
Additional Information
Cheryl Giscombe, PhD
University of North Carolina at Chapel Hill
Phone: 919-966-9905
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place