NCT04705779Completed
The HARMONY Study: A Intervention to Reduce Cardiometabolic Risk in African American Women
The HARMONY Study: A Culturally-relevant, Randomized-controlled, Stress Management Intervention to Reduce Cardiometabolic Risk in African American Women
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 175 (actual)
- First submitted
- 8 Jan 2021
- Start date
- 20 May 2021
- Primary completion date
- 7 Feb 2025
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Obesity, Stroke, High blood pressure
- NCT number
- NCT04705779
What you commit to
- Study type: Interventional
- Participants enrolled: 175
- From 20 May 2021 to the primary completion date, 7 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of weight loss medication
- Current or recent (\<6 months prior to enrollment) engagement in another weight loss or meditation program
- Lives in the same household as someone who is currently in the study or was previously in the study.
Other illness
- Substance use, mental health or medical condition that will prevent the ability to participate in the intervention
- Diabetes diagnosis
Other
- Pregnant/anticipated pregnancy
- Impaired cognition (inability to follow and respond appropriately during screening).
- Has a confirmed BMI lower than 25 or higher than 39
- Does not have access to a smartphone or computer with internet access
Who the study is looking for
- 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
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.