SHINE项目（促进公平睡眠健康倡议）的研究方案：一项以社区为基础的试验随机对照试验，旨在促进黑人/非裔美国成年人的睡眠和体育活动

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-08-29 DOI:10.1016/j.conctc.2025.101541

Ivan HC. Wu , Lorna McNeill , Kristen Knutson , Yisheng Li , Diwakar Balachandran , Rhonda Jones-Webb , Pamela L. Lutsey , Darin Erikson , Shikha Bista , Rachel Price , Vanessa Anyanso , Taylor Smith , Rev Melvin Miller

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引用次数: 0

摘要

背景：与白人相比，黑人/非裔美国人（AA）成年人的睡眠时间更短，睡眠质量更差，这导致他们患慢性病的风险更高。SHINE项目（Sleep Health INitiative for Equity，睡眠健康公平倡议）旨在通过评估一种文化量身定制的睡眠干预的可行性、满意度和合理性（即初步疗效）来解决这些睡眠差异，该干预旨在改善体重指数(BMI)≥25的AA级成人的睡眠时间和身体活动，这些成年人不符合身体活动和睡眠指南的建议。方法以社区为基础的随机对照试验（RCT）分为两个阶段。第一阶段包括对AA成人进行定性访谈，以探索与睡眠相关的社会背景因素，以完善干预措施。第二阶段是一项随机对照试验（n = 80），分配参与者进行为期四周的睡眠延长干预或接触控制。睡眠延长干预旨在改善睡眠时间和身体活动。会议通过Zoom进行，包括面对面的基线和后续访问。主要结局包括干预的可行性和满意度。次要结果包括自我报告和客观的睡眠和身体活动测量，以及癌症和心血管风险的探索性生物标志物。额外的自我报告评估睡眠相关的心理社会因素和健康行为。本研究将评估一种针对嗜酒者的虚拟睡眠干预的可行性和实施。通过整合行为改变理论、文化适应框架和社区参与原则，SHINE项目旨在为更大规模的试验提供信息，并支持可扩展的行为干预措施，以改善睡眠健康并减少差异。

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Study protocol for Project SHINE (Sleep Health INitiative for Equity): A community-based pilot RCT to promote sleep and physical activity among Black/African American adults

Background

Black/African American (AA) adults experience shorter sleep duration and poorer sleep quality compared to White counterparts, contributing to higher risks of chronic diseases. Project SHINE (Sleep Health INitiative for Equity) aims to address these sleep disparities by evaluating the feasibility, satisfaction, and plausibility (i.e., preliminary efficacy) of a culturally tailored sleep intervention designed to improve sleep duration and physical activity among AA adults with body mass index (BMI) ≥ 25 not meeting physical activity and sleep guideline recommendations.

Methods

This pilot community-based randomized controlled trial (RCT) includes two phases. Phase 1 involves qualitative interviews with AA adults to explore sleep-related sociocontextual factors to refine the intervention. Phase 2 is an RCT (n = 80) assigning participants to a four-week sleep extension intervention or a contact control. The sleep extension intervention aims to improve sleep duration and physical activity. Sessions occur via Zoom, with in-person baseline and follow-up visits. Primary outcomes include feasibility and satisfaction of the intervention. Secondary outcomes include self-reported and objective sleep and physical activity measures, plus exploratory biomarkers for cancer and cardiovascular risk. Additional self-reports assess sleep-related psychosocial factors and health behaviors.

Discussion

This study will assess the feasibility and implementation of a culturally tailored, virtual sleep intervention for AA adults. By integrating behavior change theories, cultural adaptation frameworks, and community-based participatory principles, Project SHINE aims to inform a larger-scale trial and support scalable behavioral interventions to improve sleep health and reduce disparities.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.