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NCT07581899
Mind Your Heart Intervention for American Indian Women
Conditions: Cardiovascular Health
Sex: Female
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 70
Sponsor: University of North Carolina, Chapel Hill
Location: UNC Health Primary and Specialty Care at Pembroke Pembroke North Carolina
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT07581899). StuddyBuddy aggregates publicly available trial information.