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

Sponsors and collaborators

University of North Carolina, Chapel Hill

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator