Mind Your Heart Intervention for American Indian Women
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Culturally-adapted intervention to improve cardiovascular health in American Indian women.
- Кому может быть актуально
- Состояния в реестре: Cardiovascular Health. Базовые параметры: 18 лет — 55 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
MIND Your Heart Study for American Indian Women
Обзор
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.
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
Вмешательства
- Поведенческое 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
Первичные конечные точки
- Change in Blood pressure [Срок оценки: Baseline, Week 8, and Month 3]
- Change in Heart rate variability (HRV) [Срок оценки: Baseline and Month 3]
- Change in Hs-CRP [Срок оценки: Baseline and Month 3]
- Change in Interleukin-6 (IL-6) [Срок оценки: Baseline and Month 3]
- Change in Hemoglobin A1c [Срок оценки: Baseline and Month 3]
- Change in Lipid panel [Срок оценки: Baseline and Month 3]
- Change in body mass index (BMI) [Срок оценки: Baseline, Week 8, and Month 3]
- Change in body fat percentage [Срок оценки: Baseline, Week 8, and Month 3]
Вторичные конечные точки (12)
- Change in contextualized stress: burden [Срок оценки: Baseline, Week 8, and Month 3]
- Change in perceived stress [Срок оценки: Baseline, Week 8, and Month 3]
- Change in positive psychological well-being [Срок оценки: Baseline, Week 8, and Month 3]
- Change in positive emotions [Срок оценки: Baseline, Week 8, and Month 3]
- Change in negative emotions [Срок оценки: Baseline, Week 8, and Month 3]
- Change in carotenoid concentration [Срок оценки: Baseline, Week 8, and Month 3]
- Change in physical activity [Срок оценки: Baseline, Week 8, and Month 3]
- Change in mindfulness self-regulation [Срок оценки: Baseline, Week 8, and Month 3]
- Change in eating self-efficacy [Срок оценки: Baseline, Week 8, and Month 3]
- Change in exercise self-efficacy [Срок оценки: Baseline, Week 8, and Month 3]
- Change in contextualized stress: stress states [Срок оценки: Baseline, Week 8, and Month 3]
- Change in Super Woman Schema (SWS) [Срок оценки: Baseline, Week 8, and Month 3]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
США · 1 центр
- UNC Health Primary and Specialty Care at Pembroke — Pembroke
Идентификаторы
NCT: NCT07581899 · 21-1762 · 5R34HL158947-03 · 5R34HL158947-02 · 1R34HL158947-01