Recruiting

Culturally-Adopted Intervention

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07581899

Conditions

Cardiovascular Health

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT07581899

Start date

Apr 7, 2026

Status verified date

May, 2026

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention Group

Intervention Group: 8-week culturally-adapted intervention

no intervention: Regular Care

Control Group: receives no intervention during the study

Interventions

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

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

Primary outcome measure

  • Change in Blood pressure [ Time Frame: Baseline, Week 8, and Month 3 ]
  • Change in Heart rate variability (HRV) [ Time Frame: Baseline and Month 3 ]
  • Change in Hs-CRP [ Time Frame: Baseline and Month 3 ]
  • Change in Interleukin-6 (IL-6) [ Time Frame: Baseline and Month 3 ]
  • Change in Hemoglobin A1c [ Time Frame: Baseline and Month 3 ]
  • Change in Lipid panel [ Time Frame: Baseline and Month 3 ]
  • Change in body mass index (BMI) [ Time Frame: Baseline, Week 8, and Month 3 ]
  • Change in body fat percentage [ Time Frame: Baseline, Week 8, and Month 3 ]

Central Contacts and Locations

Central contacts

Jada Brooks

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

Locations

UNC Health Primary and Specialty Care at Pembroke

Recruiting

Pembroke, North Carolina, United States, 28372

Contacts

Practice Manager

910-775-9027Paula.Mclean@unchealth.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Jun 25, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-06-25.