Mind Your Heart Intervention for American Indian Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

Qualifiers

Women 18-55 years old who self-identify as Lumbee Indian and

overweight/obese, defined as BMI >25 kg/m²

hypertensive as measured by study staff

physical inactivity

Disqualifiers

Women currently enrolled in an organized weight-loss or mindfulness program

Pregnant women or women planning to become pregnant during the study period

heart murmur

congenital heart disease

Trial design

Treatments tested in this trial

  • Culturally-adapted intervention to improve cardiovascular health in American Indian women

Treatment groups

70 Participants
are divided into 2 treatment groups

Locations

1
UNC Health Primary and Specialty Care at Pembroke28372, PembrokeNorth Carolina, United States

Sponsors and collaborators

University of North Carolina, Chapel Hill

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator