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Идёт набор NCT07220213

FELLAShip to Better Health

Без фазы С лечением High Blood Glucose High Cholesterol High Cholesterol/Hyperlipidemia Blood Sugar; High

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: FELLAship.
Кому может быть актуально
Состояния в реестре: High Blood Glucose, High Cholesterol, High Cholesterol/Hyperlipidemia, Blood Sugar; High. Базовые параметры: от 18 лет · Мужчины.
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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Обзор

The goal of this clinical trial is to evaluate the implementation and effectiveness of the FELLAship program-a church-based cardiovascular health (CVH) intervention-in Black men aged 35-70 who are at risk for heart disease, diabetes, obesity, and related conditions. The main questions this study aims to answer are: * Does participation in the FELLAship program improve cardiovascular health metrics (e.g., blood pressure, cholesterol, blood sugar) and health behaviors among Black men at The Worship Center Christian Church (TWC)? * What factors influence the adoption, delivery, and sustainability of the FELLAship program in a faith-based setting? Researchers will compare an immediate-start intervention group and a delayed-start (waitlist control) group to assess both short-term health outcomes and program implementation factors. Participants will: * Attend a 90-minute weekly session for 24 weeks, including 45 minutes of physical activity led by a certified trainer and 45 minutes of health education delivered by trained coaches. * Receive one-on-one support from a community health worker to reduce barriers to care and engage with primary care. * Complete biometric health screenings and surveys at baseline, 12 weeks, and 24 weeks to assess clinical and behavioral outcomes. * Use a smartwatch, blood pressure cuff, and other tools to track progress in real time. * Participate in exit focus groups or interviews to share feedback about the intervention. * A subset of TWC leaders and interventionists (N=15) will also be interviewed to assess implementation, resource needs, and sustainability. This study uses the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to assess Reach, Effectiveness, Adoption, Implementation, and Maintenance, and aims to inform scalable strategies for improving CVH among Black men in trusted community settings.

Вмешательства

  • Поведенческое FELLAship
    TheFELLAship intervention, grounded in Social Cognitive Theory (SCT) and guided by the Socioecological Model (SEM), focuses on enhancing participants' skills, knowledge and beliefs, and self-efficacy to promote cardiovascular health (CVH). The program provides health education aligned with the Diabetes Prevention Program (DPP) and American Heart Association's Check. Change. Control. (AHA CCC) curriculum to support behavior change in diet, physical activity, tobacco use, sleep, and clinical care

Первичные конечные точки

  • Change From Baseline in Life's Essential 8 Overall Score [Срок оценки: 24 Weeks]
Вторичные конечные точки (12)
  • Change From Baseline in Life's Essential 8 Blood Pressure Score [Срок оценки: 24 Weeks]
  • Change From Baseline in Life's Essential 8 Body Mass Index Score [Срок оценки: 24 Weeks]
  • Change in Life's Essential 8 Diet (subjective) [Срок оценки: 24 Weeks]
  • Change From Baseline in Life's Essential 8 Blood Lipids Score [Срок оценки: 24]
  • Change From Baseline in Life's Essential 8 Blood Glucose Score [Срок оценки: 24 Weeks]
  • Change From Baseline in Perceived Stress Score [Срок оценки: 24 Weeks]
  • Change in Life's Essential 8 Physical Activity (Self Reported) [Срок оценки: 24 Weeks]
  • Change in Life's Essential 8 Physical Activity (Accelerometry) [Срок оценки: 24 Weeks]
  • Change From Baseline in Life's Essential 8 Nicotine Exposure Score [Срок оценки: 24 Weeks]
  • Change From Baseline in Life's Essential 8 Sleep Health Score [Срок оценки: 24 Weeks]
  • Change From Baseline in Patient Activation Measure (PAM) Score [Срок оценки: 24 Weeks]
  • Change From Baseline in Health-Related Social Needs Score [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

  • Self-identified Black men
  • Age 18 or older
  • LE8 (Life's Essential 8) score (threshold not specified, but implies "less than ideal" CVH)
  • English speaking
  • Resides in the Metropolitan Birmingham, Alabama area
  • No physical activity restrictions imposed by a healthcare provider

Критерии исключения

  • Not identifying as Black and male
  • Under age 18
  • Non-English speakers
  • Not living in the Birmingham, Alabama metro area
  • Having a healthcare provider-imposed restriction on physical activity
  • Ideal CVH (i.e., LE8 (Life's Essential 8) score above inclusion threshold)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • The Worship Center Cristian Church — Birmingham

Идентификаторы

NCT: NCT07220213 · IRB-300015137 · UAB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗