Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults
NCT ID: NCT06226077
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
90 participants
INTERVENTIONAL
2023-10-01
2026-11-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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sleep extension intervention arm
sedentary and short sleep (=\<6 hrs/night) African American adults with overweight/obesity randomized to the sleep extension intervention.
sleep extension intervention
The sleep intervention aims to increase sleep duration by one-hour (15 minutes/week) over the course of 4-weeks using components from Cognitive Behavioral Therapy for Insomnia. More specifically, the intervention consists of psychoeducation, sleep extension, sleep hygiene, and stimulus control. Participants will meet with Dr. Wu or a trained staff member once a week over the course of 4-weeks via Zoom. The intervention will be adapted based on feedback from the community, knowledge gained during previous interviews.
education contact control arm
sedentary and short sleep (=\<6 hrs/night) African American adults with overweight/obesity randomized to contact control intervention.
contact control intervention
The control condition is a contact-control intervention whereby participants will meet with Dr. Wu or a trained staff member once-week over the course of 4-weeks to receive education materials from the Healthy Homes intervention developed by the UT School of Public Health.
Interventions
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sleep extension intervention
The sleep intervention aims to increase sleep duration by one-hour (15 minutes/week) over the course of 4-weeks using components from Cognitive Behavioral Therapy for Insomnia. More specifically, the intervention consists of psychoeducation, sleep extension, sleep hygiene, and stimulus control. Participants will meet with Dr. Wu or a trained staff member once a week over the course of 4-weeks via Zoom. The intervention will be adapted based on feedback from the community, knowledge gained during previous interviews.
contact control intervention
The control condition is a contact-control intervention whereby participants will meet with Dr. Wu or a trained staff member once-week over the course of 4-weeks to receive education materials from the Healthy Homes intervention developed by the UT School of Public Health.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
75 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Ivan Wu, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022LS170 (B)
Identifier Type: -
Identifier Source: org_study_id