Can stress relief cut heart risk? new study targets black women
NCT ID NCT04705779
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a culturally-tailored program called HARMONY for African American women at risk for heart disease, stroke, and diabetes. Over 8 sessions plus monthly boosters, participants learned stress management, exercise, and healthy eating. The goal was to see if the program could improve physical activity, diet, and overall cardiometabolic health. 175 women took part, and the study is now complete.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- behavioral intervention (stress management, exercise, and nutrition education)
- What this could lead to
- If successful, this program could offer a practical, culturally-relevant way to help African American women lower their risk of heart disease, stroke, and diabetes through better stress management and healthy habits.
- What could go wrong
- This is a completed study with 175 participants, so results are available but may not apply to all women. The intervention requires time and commitment, and long-term benefits beyond the study period are uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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175 people
The number who actually took part.
- Started
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May 2021
- Finished
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Feb 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: * \< 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. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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