Mind Your Heart Intervention for American Indian Women

MIND Your Heart Study for American Indian Women

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.

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

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