Mind Your Heart Intervention for American Indian Women
Purpose
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.
Condition
- Cardiovascular Health
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
- Masking Description
- Research assistants collecting research data
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention Group |
Intervention Group: 8-week culturally-adapted intervention |
|
|
No Intervention Control Group |
Control Group: receives no intervention during the study |
|
Recruiting Locations
Pembroke, North Carolina 28372
More Details
- Status
- Recruiting
- Sponsor
- University of North Carolina, Chapel Hill
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