The HARMONY Study: A Intervention to Reduce Cardiometabolic Risk in African American Women

Completed · Not applicable

Conditions studied: Heart Diseases, Stroke, Pre-diabetes, Hypertension, Obesity, Overweight, Stress

In brief

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.

Key facts

Study ID

NCT04705779

Run by

University of North Carolina, Chapel Hill

People needed

175

Starts

2021-05-20

Expected to finish

2025-02-07

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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