N/A
Completed N=173
The HARMONY Study: A Intervention to Reduce Cardiometabolic Risk in African American Women
Source: ClinicalTrials.gov NCT04705779 ↗Enrolled (actual)
173
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Change in Amount of Moderate to Vigorous Physical Activity — -5.89; -11.24 minutes/day
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 self-efficacy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Amount of Moderate to Vigorous Physical Activity |
-5.89; -11.24 | — |
| PRIMARY Change in the Dietary Risk Assessment Score |
0.45; 2.54 | — |
| PRIMARY Change in Veggie Meter Score |
19.85; 9.38 | — |
| SECONDARY Change in BMI |
-.09; -.56 | — |
| SECONDARY Change in Weight |
-1; -2.08 | — |
| SECONDARY Change in Waist-to-Hip Ratio |
.05; 0 | — |
| SECONDARY Change in Percent Body Fat |
1.23; -.62 | — |
| SECONDARY Change in Blood Pressure (Systolic) |
3.58; -1.44 | — |
| SECONDARY Change in Blood Pressure (Diastolic) |
0.29; -2.00 | — |
| SECONDARY Change in High Sensitivity C-Reactive Protein Amount |
-0.784; -0.450 | — |
| SECONDARY Change in IL-6 |
0.155; 0.819 | — |
| SECONDARY Change in Glycosylated Hemoglobin (HbA1c) |
-.06; -.03 | — |
Eligibility Criteria
Inclusion Criteria
- Self-reported African American or Black woman
- BMI= 25-39 kg/m^2 (confirmed at baseline assessment)
- At least one cardiometabolic risk factor:
- 5 or self-report at least "some" general stress.
Exclusion Criteria
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT04705779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.