Status:
COMPLETED
The HARMONY Study: A Intervention to Reduce Cardiometabolic Risk in African American Women
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
Heart Diseases
Stroke
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 im...
Detailed Description
Among all groups of women in the US, African American women (AAW) have the highest rates of death and disability from chronic cardiometabolic (CM) illnesses. Furthermore, AAW have inadequate engagemen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2025
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT04705779
Start Date
May 20 2021
End Date
February 7 2025
Last Update
March 14 2025
Active Locations (1)
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1
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599