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

RecruitingPhase 1, Phase 2Ages 21 Years - 75 YearsAllUniversity of Minnesota
NCT06226077 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 se

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📋 Eligibility rules (as published)
Inclusion Criteria: 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 Exclusion Criteria: 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
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What it tests

  • sleep extension intervention
  • contact control intervention
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Where

1 site
University of Minnesota
Minneapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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