NCT06226077CompletedPhase 1/2
Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 88 (actual)
- First submitted
- 16 Jan 2024
- Start date
- 1 Oct 2023
- Primary completion date
- 18 Jun 2026
- Lead sponsor
- University of Minnesota
- Diseases
- Obesity
- NCT number
- NCT06226077
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 88
- From 1 Oct 2023 to the primary completion date, 18 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)
- Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)
Other
- Phase 1:
- pregnant or less than 4 months postpartum
- infant living in household less than 1 year old
- Phase 2:
- pregnant or less than 4 months postpartum
- infant living in household less than 1 year old
Who the study is looking for
- 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
Age in the registry: 21 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.