The HARMONY Study: A Intervention to Reduce Cardiometabolic Risk in African American Women (NCT04705779) | Clinical Trial Compass
CompletedNot Applicable
The HARMONY Study: A Intervention to Reduce Cardiometabolic Risk in African American Women
United States175 participantsStarted 2021-05-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Amount of Moderate to Vigorous Physical Activity
Timeframe: Baseline, 48 weeks after first group session
2
Change in the Dietary Risk Assessment Score
Timeframe: Baseline, 48 weeks after first group session
3
Change in Veggie Meter Score
Timeframe: Baseline, 48 weeks after first group session