Mind Your Heart Intervention for American Indian Women (MYH)
22 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Estimado)
70
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jada Brooks
- Número de teléfono: 919-966-4260
- Correo electrónico: jada@email.unc.edu
Ubicaciones de estudio
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-
North Carolina
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Pembroke, North Carolina, Estados Unidos, 28372
- Reclutamiento
- UNC Health Primary and Specialty Care at Pembroke
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Contacto:
- Practice Manager
- Número de teléfono: 910-775-9027
- Correo electrónico: Paula.Mclean@unchealth.unc.edu
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention Group
Intervention Group: 8-week culturally-adapted intervention
|
A culturally-adapted cardiovascular health promotion intervention delivered for 8-weeks with American Indian women at risk for cardiovascular disease
|
|
Sin intervención: Regular Care
Control Group: receives no intervention during the study
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Blood pressure
Periodo de tiempo: 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)
Periodo de tiempo: Baseline and Month 3
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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
|
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Change in Hs-CRP
Periodo de tiempo: Baseline and Month 3
|
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)
Periodo de tiempo: 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
Periodo de tiempo: Baseline and Month 3
|
Collection of hemoglobin A1c to measure metabolic function.
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Baseline and Month 3
|
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Change in Lipid panel
Periodo de tiempo: 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.
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Baseline and Month 3
|
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Change in body mass index (BMI)
Periodo de tiempo: 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).
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Baseline, Week 8, and Month 3
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Change in body fat percentage
Periodo de tiempo: Baseline, Week 8, and Month 3
|
Collection of body fat measurements using a handheld bioelectrical impedance device.
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Baseline, Week 8, and Month 3
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in contextualized stress: burden
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Baseline, Week 8, and Month 3
|
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Change in positive psychological well-being
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Baseline, Week 8, and Month 3
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Change in negative emotions
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Baseline, Week 8, and Month 3
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Change in physical activity
Periodo de tiempo: 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.
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Baseline, Week 8, and Month 3
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Change in mindfulness self-regulation
Periodo de tiempo: 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.
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Baseline, Week 8, and Month 3
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Change in eating self-efficacy
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Baseline, Week 8, and Month 3
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Change in contextualized stress: stress states
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jada Brooks, University of North Carolina, Chapel Hill
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
7 de abril de 2026
Finalización primaria (Estimado)
1 de julio de 2026
Finalización del estudio (Estimado)
1 de julio de 2026
Fechas de registro del estudio
Enviado por primera vez
5 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de mayo de 2026
Publicado por primera vez (Actual)
12 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 21-1762
- 5R34HL158947-03 (Subvención/contrato del NIH de EE. UU.)
- 5R34HL158947-02 (Subvención/contrato del NIH de EE. UU.)
- 1R34HL158947-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
beginning 9 and continuing for 24 months
Criterios de acceso compartido de IPD
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .