NCT07581899 · University of North Carolina, Chapel Hill
Mind Your Heart Intervention for American Indian Women
(MYH)
What this study is about
The goal of this clinical trial is to learn if a culturally-adapted intervention can improve cardiovascular health in American Indian women.
View original scientific description
The goal of this clinical trial is to learn if a culturally-adapted intervention can improve cardiovascular health in American Indian women. The main questions it aims to answer are: * Can this intervention realistically work for American Indian women? * Do American Indian women find the intervention acceptable? * Does the intervention help improve cardiovascular health in American Indian women? Researchers will compare the intervention group to a control group (a group that does not receive the intervention) to see whether the cardiovascular health of the intervention group improves. Participants will: * Attend 3 data collections over 3 months. * Be randomly assigned to either the intervention group or a control group. * (Intervention group participants) attend 8 weekly classes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Pembroke, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations