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
2 other identifiers
interventional
175
1 country
1
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 improvements in self-management mediators: mindfulness, stress management, positive reappraisal, self-regulation, and self-efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2021
CompletedStudy Start
First participant enrolled
May 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2025
CompletedResults Posted
Study results publicly available
January 29, 2026
CompletedJanuary 29, 2026
March 1, 2025
3.7 years
January 8, 2021
December 19, 2025
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Amount of Moderate to Vigorous Physical Activity
The participant's moderate to vigorous physical activity will be measured by triaxial accelerometry. Participants are instructed to wear the accelerometer for seven full days; the average number of minutes of MVPA per 24-hour period is computed. Results will be reported in minutes per day.
Baseline, 48 weeks after first group session
Change in the Dietary Risk Assessment Score
The participant's dietary intake will be assessed using the dietary risk assessment, which includes 54 items. The dietary risk assessment measures the healthiness of a participant's eating habits. Score ranges from 0 to 108, with higher scores associated with less healthy dietary intake.
Baseline, 48 weeks after first group session
Change in Veggie Meter Score
The participant's nutrition will be assessed using the veggie meter, which uses light reflectance spectroscopy to provide an estimated skin carotenoid composite score. Score ranges from 0 to 800, with higher scores associated with greater fruit and vegetable intake.
Baseline, 48 weeks after first group session
Secondary Outcomes (9)
Change in BMI
Baseline, 48 weeks after first group session
Change in Weight
Baseline, 48 weeks after first group session
Change in Waist-to-Hip Ratio
Baseline, 48 weeks after first group session
Change in Percent Body Fat
Baseline, 48 weeks after first group session
Change in Blood Pressure (Systolic)
Baseline, 48 weeks after first group session
- +4 more secondary outcomes
Study Arms (2)
HARMONY
EXPERIMENTALFollowing screening, participation includes 8 regular sessions occurring over 4 months followed by 6 monthly booster sessions. Overall, study participation will last approximately 14 months.
Nutrition and Exercise Education Workgroup (NEEW)
ACTIVE COMPARATORFollowing screening, participation includes 8 regular sessions occurring over 4 months followed by 6 monthly booster sessions. Overall, study participation will last approximately 14 months.
Interventions
The HARMONY intervention will be delivered over 8 every-other-week sessions and 6 monthly booster sessions. Each session will have three components; an exercise sampler, cool down and tailored education on cardiometabolic prevention and risk reductions.
The Nutrition and Exercise Workgroup (NEEW) group will be delivered over 8 every-other-week sessions and 6 monthly booster sessions. Each session will have three components; an exercise sampler, cool down and tailored education on cardiometabolic prevention and risk reductions.
Eligibility Criteria
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
- +1 more criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Related Publications (1)
Woods-Giscombe CL, Gaylord S, Bradford A, Vines S, Eason K, Smith R, Addo-Mensah D, Lackey C, Dsouza V, Sheffield-Abdullah K, Day T, Green-Scott K, Chilcoat A, Peace-Coard A, Chalmers L, Evenson KR, Samuel-Hodge C, Lewis TT, Crandell J, Corbie G, Faurot K. Protocol of the HARMONY study: A culturally relevant, randomized-controlled, stress management intervention to reduce cardiometabolic risk in African American women. Contemp Clin Trials. 2024 Nov;146:107604. doi: 10.1016/j.cct.2024.107604. Epub 2024 Jun 10.
PMID: 38866096DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cheryl Giscombe, PhD
- Organization
- University of North Carolina at Chapel Hill
Study Officials
- PRINCIPAL INVESTIGATOR
Cheryl Giscombe, PhD, RN, PMHNP-BC, FAAN
The University of North Carolina at Chapel Hill, School of Nursing
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2021
First Posted
January 12, 2021
Study Start
May 20, 2021
Primary Completion
February 7, 2025
Study Completion
February 7, 2025
Last Updated
January 29, 2026
Results First Posted
January 29, 2026
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- The data will become available per NIH policy, which is no later than the acceptance for publication of the main findings from the dataset.
- Access Criteria
- All researchers who desire to access the individual participant data must enter into a data-sharing agreement.
Deidentified individual data that supports the results will be shared up to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.