NCT06226077 Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults
| NCT ID | NCT06226077 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Minnesota |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2023-10-01 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Ivan Wu, PhD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT06226077 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 75 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06226077 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06226077 currently recruiting?
Yes, NCT06226077 is actively recruiting participants. Contact the research team at price919@umn.edu for enrollment information.
Where is the NCT06226077 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06226077 clinical trial?
NCT06226077 is sponsored by University of Minnesota. The principal investigator is Ivan Wu, PhD at University of Minnesota. The trial plans to enroll 90 participants.
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