Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT06226077
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • sleep extension intervention — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Oct 1, 2023
Status verified
Dec 2025
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: sleep extension intervention arm
    sedentary and short sleep (=\<6 hrs/night) African American adults with overweight/obesity randomized to the sleep extension intervention.
  • Active Comparator: education contact control arm
    sedentary and short sleep (=\<6 hrs/night) African American adults with overweight/obesity randomized to contact control intervention.

Primary Outcome Measure

Feasibility of the sleep intervention [ Time Frame: 10 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55414
Rachel Price, MPH
[email protected]

Find similar trials in Minneapolis, MN

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Minnesota· Minneapolis, MN

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