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Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults
NCT06226077 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL sleep extension intervention
- BEHAVIORAL contact control intervention
Study Locations (1)
Minnesota
- University of Minnesota — Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-10-01 |
| Est. Completion | 2026-11-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06226077
The ClinicalTrials.gov registry entry for NCT06226077 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 919 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions — of which sleep extension intervention is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06226077 reports 1 study location spanning 1 distinct geographic area — top geographies include Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06226077 about?
NCT06226077 is a clinical study titled "Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults". 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. Ph...
What is the current status of trial NCT06226077?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2023-10-01. Estimated completion is 2026-11-01.
What conditions does trial NCT06226077 study?
This clinical trial studies the following conditions: Obesity, Insufficient Sleep. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06226077?
The interventions under investigation include: sleep extension intervention (BEHAVIORAL), contact control intervention (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06226077?
This trial is sponsored by University of Minnesota, which has 919 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06226077 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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