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Идёт набор NCT06226077

Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults

Фаза I / Фаза II С лечением Obesity Insufficient Sleep

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: sleep extension intervention, contact control intervention.
Кому может быть актуально
Состояния в реестре: Obesity, Insufficient Sleep. Базовые параметры: 21 лет — 75 лет · Все.
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 proposed research aims to reduce obesity-related health disparities by promoting healthy lifestyle behaviors among African Americans (AAs), given the high disease burdens associated with low physical activity, insufficient sleep, and obesity. There will be two phases to the proposed research. Phase 1 (Aim 1) will encompass formative research and community engagement activities, and Phase 2 (Aim 2a and 2b) will be a randomized clinical trial. The primary goal of Aim 1 is to conduct in-depth qualitative interviews in order to: (1) better understand sleep-related social contextual factors, knowledge, behaviors, and beliefs, and (2) discuss and receive feedback on an existing sleep intervention design and materials. The primary goal of Aim 2 is to explore the feasibility, satisfaction, and preliminary efficacy of a sleep intervention to increase sleep and physical activity (PA) among sedentary and short sleeping (≤6 hrs/night) African American adults with overweight/obesity, compared to a contact control group. (Aim 2a) An additional exploratory (Aim 2b) examines changes in cancer-relevant biomarkers between those who received the intervention vs the control condition (n = 20). Data will be collected from a sample of 20 participants (10 per condition) who volunteer to have their blood drawn pre- and post-intervention. There are two phases of the study, and information gained during Phase 1 (Aim 1) will be used to inform Phase 2 (Aim 2). Thus, additional modifications to the protocol will be submitted prior to engagement in Phase 2.

Вмешательства

  • Поведенческое sleep extension intervention
    The sleep intervention aims to increase sleep duration by one-hour (15 minutes/week) over the course of 4-weeks using components from Cognitive Behavioral Therapy for Insomnia. More specifically, the intervention consists of psychoeducation, sleep extension, sleep hygiene, and stimulus control. Participants will meet with Dr. Wu or a trained staff member once a week over the course of 4-weeks via Zoom. The intervention will be adapted based on feedback from the community, knowledge gained during
  • Поведенческое contact control intervention
    The control condition is a contact-control intervention whereby participants will meet with Dr. Wu or a trained staff member once-week over the course of 4-weeks to receive education materials from the Healthy Homes intervention developed by the UT School of Public Health.

Первичные конечные точки

  • Feasibility of the sleep intervention [Срок оценки: 10 weeks]
  • Satisfaction with the sleep intervention [Срок оценки: 10 weeks]

Критерии участия

Критерии включения

Phase 1:

  • Not meeting Physical Activity Guidelines
  • age range: 21 to 75 years
  • body mass index: ≥25.0 kg/m2
  • average self-reported habitual sleep duration of ≤6 hours
  • self-identify as Black or African American

Phase 2:

  • Not meeting Physical Activity Guidelines
  • age range: 21 to 75 years
  • body mass index: ≥25.0 kg/m2
  • average self-reported habitual sleep duration of ≤6 hours
  • self-identify as Black or African American

Критерии исключения

Phase 1:

  • Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)
  • pregnant or less than 4 months postpartum
  • infant living in household less than 1 year old

Phase 2:

  • Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)
  • pregnant or less than 4 months postpartum
  • infant living in household less than 1 year old

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
Поддерживающая терапия

Центры проведения

США · 1 центр
  • University of Minnesota — Minneapolis

Идентификаторы

NCT: NCT06226077 · 2022LS170 (B)

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗