Mind Your Heart Intervention for American Indian Women

NCT07581899 | Recruiting

• 4 other identifiers: 21-17625R34HL158947-035R34HL158947-021R34HL158947-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Health

Outcome Measures

Primary Outcomes (8)

• Change in Blood pressure

  Blood pressure will be measured three times during each appointment. The first blood pressure will be discarded, and the second and third measures will be averaged. Participants will rest 1 to 2 minutes between each reading.

  Baseline, Week 8, and Month 3

• Change in Heart rate variability (HRV)

  HRV will be measured using a dual wireless electrocardiogram portable device for 10 minutes while the participant is resting in a seated position.

  Baseline and Month 3

• Change in Hs-CRP

  Collection of high-sensitivity C-reactive protein (Hs-CRP) to measure inflammation.

  Baseline and Month 3

• Change in Interleukin-6 (IL-6)

  Collection of IL-6 to measure inflammation.

  Baseline and Month 3

• Change in Hemoglobin A1c

  Collection of hemoglobin A1c to measure metabolic function.

  Baseline and Month 3

• Change in Lipid panel

  Collection of a fasting lipid panel to measure total cholesterol, high-density lipoprotein, triglycerides, and low-density lipoprotein to measure metabolic function.

  Baseline and Month 3

• Change in body mass index (BMI)

  Collection of weight and height to calculate BMI. Weight and height will be collected two times during each visit and averaged. The average weight and height will be calculated to determine BMI. BMI is calculated as weight (kg) / height (m\^2).

  Baseline, Week 8, and Month 3

• Change in body fat percentage

  Collection of body fat measurements using a handheld bioelectrical impedance device.

  Baseline, Week 8, and Month 3

Secondary Outcomes (12)

• Change in contextualized stress: burden

  Baseline, Week 8, and Month 3

• Change in perceived stress

  Baseline, Week 8, and Month 3

• Change in positive psychological well-being

  Baseline, Week 8, and Month 3

• Change in positive emotions

  Baseline, Week 8, and Month 3

• Change in negative emotions

  Baseline, Week 8, and Month 3

Study Arms (2)

Intervention Group

EXPERIMENTAL

Intervention Group: 8-week culturally-adapted intervention

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

Control Group

NO INTERVENTION

Control Group: receives no intervention during the study

Interventions

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

A culturally-adapted cardiovascular health promotion intervention delivered for 8-weeks with American Indian women at risk for cardiovascular disease

Intervention Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: cisgender women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UNC Health Primary and Specialty Care at Pembroke

Pembroke, North Carolina, 28372, United States

RECRUITING

Study Officials

• Jada Brooks

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jada Brooks

CONTACT

919-966-4260; jada@email.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Research assistants collecting research data
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 and continuing for 24 months
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)