Overview
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.
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
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
