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.