Mind Your Heart Intervention for American Indian Women (MYH)
22 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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
Type d'étude
Interventionnel
Inscription (Estimé)
70
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Jada Brooks
- Numéro de téléphone: 919-966-4260
- E-mail: jada@email.unc.edu
Lieux d'étude
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North Carolina
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Pembroke, North Carolina, États-Unis, 28372
- Recrutement
- UNC Health Primary and Specialty Care at Pembroke
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Contact:
- Practice Manager
- Numéro de téléphone: 910-775-9027
- E-mail: Paula.Mclean@unchealth.unc.edu
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention Group
Intervention Group: 8-week culturally-adapted intervention
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A culturally-adapted cardiovascular health promotion intervention delivered for 8-weeks with American Indian women at risk for cardiovascular disease
|
|
Aucune intervention: Regular Care
Control Group: receives no intervention during the study
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Blood pressure
Délai: 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.
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Baseline, Week 8, and Month 3
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Change in Heart rate variability (HRV)
Délai: 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.
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Baseline and Month 3
|
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Change in Hs-CRP
Délai: Baseline and Month 3
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Collection of high-sensitivity C-reactive protein (Hs-CRP) to measure inflammation.
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Baseline and Month 3
|
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Change in Interleukin-6 (IL-6)
Délai: Baseline and Month 3
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Collection of IL-6 to measure inflammation.
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Baseline and Month 3
|
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Change in Hemoglobin A1c
Délai: Baseline and Month 3
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Collection of hemoglobin A1c to measure metabolic function.
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Baseline and Month 3
|
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Change in Lipid panel
Délai: Baseline and Month 3
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Collection of a fasting lipid panel to measure total cholesterol, high-density lipoprotein, triglycerides, and low-density lipoprotein to measure metabolic function.
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Baseline and Month 3
|
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Change in body mass index (BMI)
Délai: Baseline, Week 8, and Month 3
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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
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Change in body fat percentage
Délai: Baseline, Week 8, and Month 3
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Collection of body fat measurements using a handheld bioelectrical impedance device.
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Baseline, Week 8, and Month 3
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in contextualized stress: burden
Délai: 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.
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Baseline, Week 8, and Month 3
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Change in perceived stress
Délai: Baseline, Week 8, and Month 3
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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.
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Baseline, Week 8, and Month 3
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Change in positive psychological well-being
Délai: 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.
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Baseline, Week 8, and Month 3
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Change in positive emotions
Délai: Baseline, Week 8, and Month 3
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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.
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Baseline, Week 8, and Month 3
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Change in negative emotions
Délai: 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.
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Baseline, Week 8, and Month 3
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Change in carotenoid concentration
Délai: Baseline, Week 8, and Month 3
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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.
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Baseline, Week 8, and Month 3
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Change in physical activity
Délai: Baseline, Week 8, and Month 3
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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.
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Baseline, Week 8, and Month 3
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Change in mindfulness self-regulation
Délai: Baseline, Week 8, and Month 3
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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.
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Baseline, Week 8, and Month 3
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Change in eating self-efficacy
Délai: 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.
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Baseline, Week 8, and Month 3
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Change in exercise self-efficacy
Délai: Baseline, Week 8, and Month 3
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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.
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Baseline, Week 8, and Month 3
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Change in contextualized stress: stress states
Délai: 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.
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Baseline, Week 8, and Month 3
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Change in Super Woman Schema (SWS)
Délai: Baseline, Week 8, and Month 3
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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.
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Baseline, Week 8, and Month 3
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Jada Brooks, University of North Carolina, Chapel Hill
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
7 avril 2026
Achèvement primaire (Estimé)
1 juillet 2026
Achèvement de l'étude (Estimé)
1 juillet 2026
Dates d'inscription aux études
Première soumission
5 mai 2026
Première soumission répondant aux critères de contrôle qualité
5 mai 2026
Première publication (Réel)
12 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 juin 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 21-1762
- 5R34HL158947-03 (Subvention/contrat des NIH des États-Unis)
- 5R34HL158947-02 (Subvention/contrat des NIH des États-Unis)
- 1R34HL158947-01 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage IPD
beginning 9 and continuing for 24 months
Critères d'accès au partage IPD
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .