Trial results for the HARMONY study, focusing on cardiometabolic risk reduction in African American women, were posted on ClinicalTrials.gov on 2026-01-29, with 175 participants enrolled.
Background
Cardiometabolic risk factors, including hypertension, obesity, pre-diabetes, and the risk of heart disease and stroke, disproportionately affect African American women. Lifestyle interventions focusing on nutrition and exercise are crucial for managing these risks. The HARMONY study aimed to test a culturally-tailored intervention designed to promote sustained improvements in healthy behaviors by addressing self-management mediators such as mindfulness, stress management, positive reappraisal, self-regulation, and self-efficacy.
Trial design
This completed study, designated as Phase NA, enrolled 175 participants to investigate conditions including Heart Diseases, Stroke, Pre-diabetes, Hypertension, and Obesity. The trial tested a culturally-tailored nutrition and exercise intervention designed for African American women (HARMONY group) against a Nutrition and Exercise Education Workgroup (NEEW) to assess improvements in exercise and healthy eating through self-management mediators.
Key results
The trial reported several key measurements for both the HARMONY group and the Nutrition and Exercise Education Workgroup (NEEW):
- Change in Amount of Moderate to Vigorous Physical Activity (minutes/day):
- HARMONY: Mean -5.89 (Standard Deviation 63.56)
- Nutrition and Exercise Education Workgroup (NEEW): Mean -11.24 (Standard Deviation 58.40)
- Change in the Dietary Risk Assessment Score (score on a scale):
- HARMONY: Mean 0.45 (Standard Deviation 4.32)
- Nutrition and Exercise Education Workgroup (NEEW): Mean 2.54 (Standard Deviation 4.31)
- Change in Veggie Meter Score (score on a scale):
- HARMONY: Mean 19.85 (Standard Deviation 81.85)
- Nutrition and Exercise Education Workgroup (NEEW): Mean 9.38 (Standard Deviation 94.17)
- Change in BMI (kg/m^2):
- HARMONY: Mean -0.09 (Standard Deviation 1.83)
- Nutrition and Exercise Education Workgroup (NEEW): Mean -0.56 (Standard Deviation 2.07)
- Change in Weight (kg):
- HARMONY: Mean -1 (Standard Deviation 4.54)
- Nutrition and Exercise Education Workgroup (NEEW): Mean -2.08 (Standard Deviation 5.53)
- Change in Waist-to-Hip Ratio (unitless ratio):
- HARMONY: Mean 0.05 (Standard Deviation 0.12)
- Nutrition and Exercise Education Workgroup (NEEW): Mean 0 (Standard Deviation 0.09)
What this means
The HARMONY study reported varied changes across several cardiometabolic risk factors. The HARMONY intervention group showed a mean decrease in moderate to vigorous physical activity of -5.89 minutes/day, an increase in dietary risk assessment score of 0.45, and an increase in waist-to-hip ratio of 0.05. However, positive changes were also observed, including a mean increase in Veggie Meter score of 19.85, a mean decrease in BMI of -0.09 kg/m^2, and a mean weight loss of -1 kg. The Nutrition and Exercise Education Workgroup (NEEW) also showed varied outcomes, with a mean decrease in physical activity of -11.24 minutes/day, an increase in dietary risk assessment score of 2.54, and a mean weight loss of -2.08 kg. These results suggest that while some improvements in lifestyle and anthropometric measures were noted in both groups, the overall impact was mixed, and no statistical comparisons between groups or against a baseline were provided in the posted data. Further analysis would be needed to determine the clinical significance of these observed changes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04705779, titled "The HARMONY Study: A Intervention to Reduce Cardiometabolic Risk in African American Women", were posted on 2026-01-29 on clinicaltrials.gov.