Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults
Recruiting · NCT06226077 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Minnesota
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- University of Minnesota - Minneapolis, Minnesota, United States