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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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
- Conditions
- Cardiovascular Health
- 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 group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention Group: 8-week culturally-adapted intervention Receives: Behavioral: Culturally-adapted intervention to improve cardiovascular health in American Indian women |
| Regular Care | No intervention | Control Group: receives no intervention during the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Change in Hs-CRP
Collection of high-sensitivity C-reactive protein (Hs-CRP) to measure inflammation.
Measured: Baseline and Month 3
Change in Interleukin-6 (IL-6)
Collection of IL-6 to measure inflammation.
Measured: Baseline and Month 3
Change in Hemoglobin A1c
Collection of hemoglobin A1c to measure metabolic function.
Measured: 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.
Measured: 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).
Measured: Baseline, Week 8, and Month 3
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)
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted12 May 2026
- Study start7 Apr 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jada Brooks, Principal investigator, University of North Carolina, Chapel Hill
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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIND Your Heart Study for American Indian Women
- ClinicalTrials.gov ID
- NCT07581899
- Acronym / sponsor ID
- MYH / 21-1762
- Conditions
- Cardiovascular Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Culturally-adapted intervention to improve cardiovascular health in American Indian womenIntervention Group: 8-week culturally-adapted intervention |
| Regular Care | No intervention | –Control Group: receives no intervention during the study |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women 18-55 years old who self-identify as Lumbee Indian and
- Have one or more risk factors for cardiovascular disease:
- Willing and able to follow study procedures
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally-adapted intervention to improve cardiovascular health in American Indian womenA culturally-adapted cardiovascular health promotion intervention delivered for 8-weeks with American Indian women at risk for cardiovascular disease | Behavioural | Intervention Group |
Primary outcome
Change in Blood pressure
Time frame: Baseline, Week 8, and Month 3
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.
Change in Heart rate variability (HRV)
Time frame: Baseline and Month 3
HRV will be measured using a dual wireless electrocardiogram portable device for 10 minutes while the participant is resting in a seated position.
Change in Hs-CRP
Time frame: Baseline and Month 3
Collection of high-sensitivity C-reactive protein (Hs-CRP) to measure inflammation.
Change in Interleukin-6 (IL-6)
Time frame: Baseline and Month 3
Collection of IL-6 to measure inflammation.
Change in Hemoglobin A1c
Time frame: Baseline and Month 3
Collection of hemoglobin A1c to measure metabolic function.
Change in Lipid panel
Time frame: Baseline and Month 3
Collection of a fasting lipid panel to measure total cholesterol, high-density lipoprotein, triglycerides, and low-density lipoprotein to measure metabolic function.
Change in body mass index (BMI)
Time frame: Baseline, Week 8, and Month 3
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).
Change in body fat percentage
Time frame: Baseline, Week 8, and Month 3
Collection of body fat measurements using a handheld bioelectrical impedance device.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jada Brooks principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
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.