Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Satisfaction with the sleep intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
- •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
结局指标
主要结局
Satisfaction with the sleep intervention
时间窗: 10 weeks
satisfaction is defined as Client Satisfaction Questionaire score \>=20, range 8-32, with higher scores indicating higher satisfaction.
Feasibility of the sleep intervention
时间窗: 10 weeks
feasibility is defined as 75% intervention attendance (3/4 sessions)
次要结局
未报告次要终点