Mind Your Heart Intervention for American Indian Women (MYH)

University of North Carolina (UNC)

Status

Enrolling

Conditions

Cardiovascular Health

Treatments

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

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07581899

1R34HL158947-01 (U.S. NIH Grant/Contract)

5R34HL158947-02 (U.S. NIH Grant/Contract)

5R34HL158947-03 (U.S. NIH Grant/Contract)

21-1762

Details and patient eligibility

About

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.

Full 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

Enrollment

70 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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