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Mind Your Heart Intervention for American Indian Women (MYH)

22 июня 2026 г. обновлено: 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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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

Тип исследования

Интервенционный

Регистрация (Оцененный)

70

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Jada Brooks
  • Номер телефона: 919-966-4260
  • Электронная почта: jada@email.unc.edu

Места учебы

  • Соединенные Штаты
    • North Carolina
      • Pembroke, North Carolina, Соединенные Штаты, 28372
        • Рекрутинг
        • UNC Health Primary and Specialty Care at Pembroke
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый

Принимает здоровых добровольцев

Нет

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Intervention Group
Intervention Group: 8-week culturally-adapted intervention
Поведенческий: 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
Без вмешательства: Regular Care
Control Group: receives no intervention during the study

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Blood pressure
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: Baseline and Month 3
Collection of IL-6 to measure inflammation.
Baseline and Month 3
Change in Hemoglobin A1c
Временное ограничение: Baseline and Month 3
Collection of hemoglobin A1c to measure metabolic function.
Baseline and Month 3
Change in Lipid panel
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: Baseline, Week 8, and Month 3
Collection of body fat measurements using a handheld bioelectrical impedance device.
Baseline, Week 8, and Month 3

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in contextualized stress: burden
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University of North Carolina, Chapel Hill

Соавторы

National Heart, Lung, and Blood Institute (NHLBI)

Следователи

  • Главный следователь: Jada Brooks, University of North Carolina, Chapel Hill

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

7 апреля 2026 г.

Первичное завершение (Оцененный)

1 июля 2026 г.

Завершение исследования (Оцененный)

1 июля 2026 г.

Даты регистрации исследования

Первый отправленный

5 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

5 мая 2026 г.

Первый опубликованный (Действительный)

12 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

25 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

22 июня 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • 21-1762
  • 5R34HL158947-03 (Грант/контракт NIH США)
  • 5R34HL158947-02 (Грант/контракт NIH США)
  • 1R34HL158947-01 (Грант/контракт NIH США)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана 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.

Сроки обмена IPD

beginning 9 and continuing for 24 months

Критерии совместного доступа к IPD

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

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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