Mind Your Heart program for Lumbee women
MIND Your Heart Study for American Indian Women
NA · University of North Carolina, Chapel Hill · NCT07581899
This program will try an 8-week culturally adapted course to see if it improves heart health for Lumbee American Indian women at risk for cardiovascular disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | University of North Carolina, Chapel Hill (other) |
| Locations | 1 site (Pembroke, North Carolina) |
| Trial ID | NCT07581899 on ClinicalTrials.gov |
What this trial studies
This is a 3-month randomized controlled pilot that will compare an 8-week culturally adapted intervention to a control group to test feasibility, acceptability, and initial effects on cardiovascular health in American Indian women. Participants are randomly assigned and complete three data collections over the study period, while those in the intervention attend eight weekly classes. Primary outcomes include blood pressure, heart rate variability, inflammatory markers, and metabolic function, with secondary outcomes of stress, positive well-being, health behaviors, self-regulation, and self-efficacy. The trial is designed to gather preliminary efficacy data and information about whether the program is practical and acceptable in this community.
Who should consider this trial
Good fit: Women 18–55 who self-identify as Lumbee, have one or more cardiovascular risk factors (BMI >25, measured hypertension, or physical inactivity), and are willing and able to attend classes and study visits are ideal candidates.
Not a fit: Women who are pregnant or planning pregnancy during the study, currently enrolled in organized weight-loss or mindfulness programs, or who have exclusionary conditions such as significant congenital heart disease, heart murmur, family history of sudden death, or orthopedic limitations are unlikely to benefit from or be eligible for this program.
Why it matters
Potential benefit: If successful, the program could lower blood pressure and improve metabolic, inflammatory, and stress-related measures in participating American Indian women.
How similar studies have performed: Similar culturally adapted lifestyle and mindfulness interventions have shown benefits for cardiovascular risk factors in other populations, but this exact program for Lumbee women is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women 18-55 years old who self-identify as Lumbee Indian and * Have one or more risk factors for cardiovascular disease: * overweight/obese, defined as BMI \>25 kg/m\^2 * hypertensive as measured by study staff * physical inactivity * Willing and able to follow study procedures Exclusion Criteria: * Women currently enrolled in an organized weight-loss or mindfulness program * Pregnant women or women planning to become pregnant during the study period * Conditions that exclude study enrollment include: * heart murmur * congenital heart disease * family history of sudden death * or orthopedic limitations or health conditions precluding exercise
Where this trial is running
Pembroke, North Carolina
- UNC Health Primary and Specialty Care at Pembroke — Pembroke, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Jada Brooks — University of North Carolina, Chapel Hill
- Study coordinator: Jada Brooks
- Email: jada@email.unc.edu
- Phone: 919-966-4260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiovascular Health