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NCT07581899NARecruiting

Mind Your Heart Intervention for American Indian Women

University of North Carolina, Chapel Hill

Start Date

4/7/2026

Completion Date

7/1/2026

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.

Detailed Description

Conduct a 3-month randomized controlled pilot study to examine feasibility, acceptability, and initial efficacy of an 8-week, culturally-adapted intervention in American Indian women at risk for cardiovascular disease on the following outcomes: Primary cardiovascular health outcomes: * blood pressure * heart rate variability * inflammatory markers * metabolic function Secondary outcomes: * stress * positive psychological well-being * health behaviors (diet, exercise) * self-regulation * self-efficacy

Eligibility Criteria

Age Range: 18 years to 55 years

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

Interventions

BEHAVIORAL

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

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Conditions

Cardiovascular Health

Locations

UNC Health Primary and Specialty Care at Pembroke

Pembroke, North Carolina 28372

United States