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Recruiting NCT07581899

Mind Your Heart Intervention for American Indian Women

No phase Interventional Cardiovascular Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Culturally-adapted intervention to improve cardiovascular health in American Indian women.
Who it may be relevant to
Registry conditions: Cardiovascular Health. Basic parameters: 18 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

MIND Your Heart Study for American Indian Women

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.

Detailed 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

Interventions

  • Behavioral 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 measures

  • 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]
Secondary outcome measures (12)
  • Change in contextualized stress: burden [Time frame: Baseline, Week 8, and Month 3]
  • Change in perceived stress [Time frame: Baseline, Week 8, and Month 3]
  • Change in positive psychological well-being [Time frame: Baseline, Week 8, and Month 3]
  • Change in positive emotions [Time frame: Baseline, Week 8, and Month 3]
  • Change in negative emotions [Time frame: Baseline, Week 8, and Month 3]
  • Change in carotenoid concentration [Time frame: Baseline, Week 8, and Month 3]
  • Change in physical activity [Time frame: Baseline, Week 8, and Month 3]
  • Change in mindfulness self-regulation [Time frame: Baseline, Week 8, and Month 3]
  • Change in eating self-efficacy [Time frame: Baseline, Week 8, and Month 3]
  • Change in exercise self-efficacy [Time frame: Baseline, Week 8, and Month 3]
  • Change in contextualized stress: stress states [Time frame: Baseline, Week 8, and Month 3]
  • Change in Super Woman Schema (SWS) [Time frame: Baseline, Week 8, and Month 3]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • UNC Health Primary and Specialty Care at Pembroke — Pembroke

Identifiers

NCT: NCT07581899 · 21-1762 · 5R34HL158947-03 · 5R34HL158947-02 · 1R34HL158947-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗