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Mind Your Heart Intervention for American Indian Women (MYH)

5 maggio 2026 aggiornato da: University of North Carolina, Chapel Hill

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:

  • 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Interventistico

Iscrizione (Stimato)

70

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • North Carolina
      • Pembroke, North Carolina, Stati Uniti, 28372
        • Reclutamento
        • UNC Health Primary and Specialty Care at Pembroke
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention Group
Intervention Group: 8-week culturally-adapted intervention
Comportamentale: 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
Nessun intervento: Control Group
Control Group: receives no intervention during the study

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Blood pressure
Lasso di tempo: 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.
Baseline, Week 8, and Month 3
Change in Heart rate variability (HRV)
Lasso di tempo: 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.
Baseline and Month 3
Change in Hs-CRP
Lasso di tempo: Baseline and Month 3
Collection of high-sensitivity C-reactive protein (Hs-CRP) to measure inflammation.
Baseline and Month 3
Change in Interleukin-6 (IL-6)
Lasso di tempo: Baseline and Month 3
Collection of IL-6 to measure inflammation.
Baseline and Month 3
Change in Hemoglobin A1c
Lasso di tempo: Baseline and Month 3
Collection of hemoglobin A1c to measure metabolic function.
Baseline and Month 3
Change in Lipid panel
Lasso di tempo: 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.
Baseline and Month 3
Change in body mass index (BMI)
Lasso di tempo: 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).
Baseline, Week 8, and Month 3
Change in body fat percentage
Lasso di tempo: Baseline, Week 8, and Month 3
Collection of body fat measurements using a handheld bioelectrical impedance device.
Baseline, Week 8, and Month 3

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in contextualized stress: burden
Lasso di tempo: Baseline, Week 8, and Month 3
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.
Baseline, Week 8, and Month 3
Change in perceived stress
Lasso di tempo: Baseline, Week 8, and Month 3
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.
Baseline, Week 8, and Month 3
Change in positive psychological well-being
Lasso di tempo: Baseline, Week 8, and Month 3
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.
Baseline, Week 8, and Month 3
Change in positive emotions
Lasso di tempo: Baseline, Week 8, and Month 3
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.
Baseline, Week 8, and Month 3
Change in negative emotions
Lasso di tempo: Baseline, Week 8, and Month 3
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.
Baseline, Week 8, and Month 3
Change in carotenoid concentration
Lasso di tempo: Baseline, Week 8, and Month 3
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.
Baseline, Week 8, and Month 3
Change in physical activity
Lasso di tempo: Baseline, Week 8, and Month 3
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.
Baseline, Week 8, and Month 3
Change in mindfulness self-regulation
Lasso di tempo: Baseline, Week 8, and Month 3
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.
Baseline, Week 8, and Month 3
Change in eating self-efficacy
Lasso di tempo: Baseline, Week 8, and Month 3
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.
Baseline, Week 8, and Month 3
Change in exercise self-efficacy
Lasso di tempo: Baseline, Week 8, and Month 3
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.
Baseline, Week 8, and Month 3
Change in contextualized stress: stress states
Lasso di tempo: Baseline, Week 8, and Month 3
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.
Baseline, Week 8, and Month 3
Change in Super Woman Schema (SWS)
Lasso di tempo: Baseline, Week 8, and Month 3
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.
Baseline, Week 8, and Month 3

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of North Carolina, Chapel Hill

Collaboratori

National Heart, Lung, and Blood Institute (NHLBI)

Investigatori

  • Investigatore principale: Jada Brooks, University of North Carolina, Chapel Hill

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

7 aprile 2026

Completamento primario (Stimato)

1 luglio 2026

Completamento dello studio (Stimato)

1 luglio 2026

Date di iscrizione allo studio

Primo inviato

5 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 21-1762
  • 5R34HL158947-03 (Sovvenzione/contratto NIH degli Stati Uniti)
  • 5R34HL158947-02 (Sovvenzione/contratto NIH degli Stati Uniti)
  • 1R34HL158947-01 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

beginning 9 and continuing for 24 months

Criteri di accesso alla condivisione IPD

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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