RecruitingNot Applicable

Mind Your Heart Intervention for American Indian Women

United States70 participantsStarted 2026-04-07

Plain-language summary

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

Age range

18 Years – 55 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: * 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

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

Change in Blood pressure

Timeframe: Baseline, Week 8, and Month 3

Change in Heart rate variability (HRV)

Timeframe: Baseline and Month 3

Change in Hs-CRP

Timeframe: Baseline and Month 3

Change in Interleukin-6 (IL-6)

Timeframe: Baseline and Month 3

Change in Hemoglobin A1c

Timeframe: Baseline and Month 3

Change in Lipid panel

Timeframe: Baseline and Month 3

Change in body mass index (BMI)

Timeframe: Baseline, Week 8, and Month 3

Change in body fat percentage

Timeframe: Baseline, Week 8, and Month 3

Trial details

NCT IDNCT07581899

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Jada Brooks

919-966-4260 jada@email.unc.edu

View on ClinicalTrials.gov More Cardiovascular Health trials

Plain-language summary

Who can participate

Age range

18 Years – 55 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.

What they're measuring

Change in Blood pressure

Timeframe: Baseline, Week 8, and Month 3

Change in Heart rate variability (HRV)

Timeframe: Baseline and Month 3

Change in Hs-CRP

Timeframe: Baseline and Month 3

Change in Interleukin-6 (IL-6)

Timeframe: Baseline and Month 3

Change in Hemoglobin A1c

Timeframe: Baseline and Month 3

Change in Lipid panel

Timeframe: Baseline and Month 3

Change in body mass index (BMI)

Timeframe: Baseline, Week 8, and Month 3

Change in body fat percentage

Timeframe: Baseline, Week 8, and Month 3