Actively Recruiting
MIND Your Heart Study for American Indian Women Evaluating a Culturally-Adapted Cardiovascular Health Intervention
Led by University of North Carolina, Chapel Hill · Updated on 2026-05-12
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether a culturally-adapted intervention can improve cardiovascular health specifically in American Indian women. The study focuses on determining if the intervention is realistic and acceptable for this group and whether it leads to improvements in heart-related measures. Researchers will compare women who receive the intervention to a control group that does not, to assess changes in cardiovascular health. The trial is a randomized controlled pilot study lasting three months. Participants assigned to the intervention group will attend eight weekly classes designed to promote cardiovascular health with cultural adaptations for American Indian women. The control group will not receive any intervention during the study. The study focuses on several primary cardiovascular outcomes such as blood pressure, heart rate variability, inflammatory markers, and metabolic function. Secondary outcomes include stress levels, positive well-being, health behaviors like diet and exercise, self-regulation, and self-efficacy. Participants will attend three data collection visits over the three-month period where measurements will be taken at baseline, week 8, and month 3. These assessments include blood pressure, heart rate variability, blood tests for various markers, body mass index, body fat percentage, stress evaluations, and psychological questionnaires. The study monitors changes over time to understand the intervention's impact and to track participant adherence and safety throughout the trial.
CONDITIONS
Brief Title
Mind Your Heart Intervention for American Indian Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 to 55 years old who self-identify as Lumbee Indian
- Have one or more risk factors for cardiovascular disease including overweight (BMI over 25), hypertension measured by study staff, or physical inactivity
- Willing and able to follow study procedures
You will not qualify if you...
- Currently enrolled in an organized weight-loss or mindfulness program
- Pregnant or planning to become pregnant during the study period
- Heart murmur
- Congenital heart disease
- Family history of sudden death
- Orthopedic limitations or health conditions preventing exercise participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants in the intervention group receive a culturally-adapted cardiovascular health promotion program over 8 weeks. Participants in the control group do not receive an intervention during this time.
Visits at baseline and Week 8
Duration - 4 weeks
Participants are monitored for cardiovascular health outcomes and behavioral measures for an additional month after the intervention period.
1 visit at Month 3
Trial Site Locations
Total: 1 location
1
UNC Health Primary and Specialty Care at Pembroke
Pembroke, North Carolina, United States, 28372
Actively Recruiting
Research Team
J
Jada Brooks
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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