Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults
Eligible age
21–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Minnesota
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Minneapolis
Source: ClinicalTrials.gov · NCT06226077 · last updated 2025-12-17