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Cardiovascular HealthMYHNCT07581899

Mind Your Heart Intervention for American Indian Women

A study testing Culturally-adapted intervention to improve cardiovascular health in American Indian women in people with Cardiovascular Health, run by University of North Carolina, Chapel Hill at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 years, women only
Conditions the study is for
Cardiovascular Health
What is being tested?
Culturally-adapted intervention to improve cardiovascular health in American Indian women
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
7 Apr 2026to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UNC Health Primary and Specialty Care at Pembroke

    Pembroke, North Carolina, 28372

Other trials in United States

About this study

Official title: 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:

Read more
  • 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.
Read the 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
Being tested
Culturally-adapted intervention to improve cardiovascular health in American Indian women

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Culturally-adapted intervention to improve cardiovascular health in American Indian womenBehavioural

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

Study groups in NCT07581899
Study groupRoleWhat they receive
Intervention GroupExperimentalIntervention Group: 8-week culturally-adapted intervention
Receives: Behavioral: Culturally-adapted intervention to improve cardiovascular health in American Indian women
Regular CareNo interventionControl Group: receives no intervention during the study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 8, and Month 3

  2. 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.

    Measured: Baseline and Month 3

  3. Change in Hs-CRP

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

    Measured: Baseline and Month 3

  4. Change in Interleukin-6 (IL-6)

    Collection of IL-6 to measure inflammation.

    Measured: Baseline and Month 3

  5. Change in Hemoglobin A1c

    Collection of hemoglobin A1c to measure metabolic function.

    Measured: Baseline and Month 3

  6. 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.

    Measured: Baseline and Month 3

  7. 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).

    Measured: Baseline, Week 8, and Month 3

  8. Change in body fat percentage

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

    Measured: Baseline, Week 8, and Month 3

Secondary outcomes (12)
  1. Change in contextualized stress: burden

    The investigators will measure burden (as a subscale of contextualized stress) using the Jackson, Hogue, Phillips (JHP) Contextualized Stress Measure (Gendered and Financial Stress) Burden Subscale. 17-item subscale of the JHP Contextualized Stress measure assessing chronic exposure to gendered and racialized stress. The burden subscale uses a 6-point Likert scale (1=Strongly Agree to 5=Strongly Disagree; 6=Not Applicable). Scores range from 17-102 with higher scores reflect a better outcome.

    Measured: Baseline, Week 8, and Month 3

  2. Change in perceived stress

    Perceived stress will be measured using the Perceived Stress Scale (PSS), a 10-item scale assessing stress experiences over the preceding month. The PSS measures the frequency of feelings and thoughts using a 5-point Likert scale, where positive responses are scored in reverse. The PSS score is determined by totaling all responses and ranges from 0 to 40 with lower scores reflecting a better outcome.

    Measured: Baseline, Week 8, and Month 3

  3. Change in positive psychological well-being

    Mental Health Continuum - Short Form (MHC-SF) measures positive emotions and comprises 14 items, representing emotional well-being, psychosocial well-being, and social well-being. On a 6-point Likert scale (0 = never; 5 = everyday), respondents indicate how often they felt various positive feelings in the past month and the extent of their agreement or disagreement with various statements indicative of psychosocial and social well-being. Possible scores for the MHC-SF range from 0 - 70. Higher scores reflect a better outcome.

    Measured: Baseline, Week 8, and Month 3

  4. Change in positive emotions

    The Modified Differential Emotions Scale (mDES) will be used to capture a broader array of emotions. Respondents rate the frequency of their experiences of 20 different emotions over the past two weeks, using a 5-point scale (0 = not at all; 4 = most of the time). Items are summed for both positive and negative emotions (both ranging from 0 - 40). Higher scores on the positive subscale indicate more positive emotions.

    Measured: Baseline, Week 8, and Month 3

  5. Change in negative emotions

    The Modified Differential Emotions Scale (mDES) will be used to capture a broader array of emotions. Respondents rate the frequency of their experiences of 20 different emotions over the past two weeks, using a 5-point scale (0 = not at all; 4 = most of the time). Items are summed for both positive and negative emotions (both ranging from 0 - 40). Higher scores on the negative subscale indicate more negative emotions.

    Measured: Baseline, Week 8, and Month 3

  6. Change in carotenoid concentration

    As a proxy for fruit and vegetable (F/V) intake, carotenoid concentrations in the skin will be measured using a portable, non-invasive, pressure-mediated reflection spectroscopy device called the Veggie Meter. The Veggie Meter produces a score from 0 to 800, with higher scores indicating greater skin carotenoid levels, which suggest a greater intake of fruits and vegetables.

    Measured: Baseline, Week 8, and Month 3

  7. Change in physical activity

    Physical activity will be measured by total time being active. Investigators will collect activity data over a 7-day span using an accelerometer worn on the wrist.

    Measured: Baseline, Week 8, and Month 3

  8. Change in mindfulness self-regulation

    Mindfulness self-regulation will be measured using the Five Facet Mindfulness Questionnaire (FFMQ), a 39-item, self-administered measure that assesses various aspects of mindfulness. Responses range from 1 (never/very rarely true) to 5 (almost always/always true) and are summed for a final score. Higher scores indicate greater mindfulness. Total scores range from 39 - 195.

    Measured: Baseline, Week 8, and Month 3

  9. Change in eating self-efficacy

    Eating self-efficacy will be measured using the Eating Self-Efficacy Scale, a 25-item tool asking respondents to rate their difficulty in controlling eating from 1 (no difficulty) to 7 (most difficultly). Scores range from 25 - 175 with higher total scores indicating lower self-efficacy.

    Measured: Baseline, Week 8, and Month 3

  10. Change in exercise self-efficacy

    Exercise self-efficacy will be measured using the Self-Efficacy for Exercise Scale (SEE), which records the strength of efficacy beliefs by 9 questions on a 11-point scale from 0 (cannot do at all) to 10 (certain can do). Scores range from 0 - 90 with higher scores indicating greater exercise self-efficacy.

    Measured: Baseline, Week 8, and Month 3

  11. Change in contextualized stress: stress states

    The investigators will measure stress states (as a subscale of contextualized stress) using the Jackson, Hogue, Phillips (JHP) Contextualized Stress Measure (Gendered and Financial Stress) Stress States Subscale. 4-item subscale of the JHP Contextualized Stress assessing chronic exposure to gendered and racialized stress. The stress states subscale uses a 6-point Likert scale (1=Strongly Agree to 5=Strongly Disagree; 6=Not Applicable). Higher scores indicate greater stress.

    Measured: Baseline, Week 8, and Month 3

  12. Change in Super Woman Schema (SWS)

    35-item measures 5 dimensions of internalized strength, emotion suppression, vulnerability resistance, motivation, and caretaking. Items are summed using a Likert scale (0=not true to 4=true all the time). Low SWS = 0-36; Moderate SWS = 36-70; High SWS = 71-105. Higher scores indicate closer alignment to the schema.

    Measured: Baseline, Week 8, and Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2026
  2. Study start7 Apr 2026
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07581899
Sponsor's protocol ID
21-1762
Other IDs
5R34HL158947-03, 5R34HL158947-02, 1R34HL158947-01
Acronym
MYH
Status last verified
Oct 2026
First submitted
5 May 2026
Last updated
2 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual data that supports the results will be shared beginning 9 and continuing for 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Questions about this trial

What is this clinical trial studying?

A study testing Culturally-adapted intervention to improve cardiovascular health in American Indian women in people with Cardiovascular Health, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Blood pressure (time frame: Baseline, Week 8, and Month 3). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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