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NCT06226077 · ClinicalTrials.gov registry record · Phase 1
Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults
A Phase 1 study of Obesity and Insufficient Sleep, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT06226077: Recruiting Phase 1 study of Obesity and Insufficient Sleep, sponsored by University of Minnesota.
NCT06226077 is a Phase 1 study of Obesity and Insufficient Sleep that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 90 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06226077, a Phase 1 study of Obesity and Insufficient Sleep, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
feasibility is defined as 75% intervention attendance (3/4 sessions)
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 |
What NCT06226077 shows while recruiting
NCT06226077 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (89% lower).
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.
NCT06226077 reports a single indexed study location in Minnesota.
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.
What interventions are being tested in trial NCT06226077?
The interventions under investigation include: sleep extension intervention (BEHAVIORAL), contact control intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT06226077?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06226077's enrollment target sits among peer trials
90 520th of 1053 higher than 526 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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