RecruitingPhase 1Phase 2NCT06226077

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

Sponsor

University of Minnesota

Enrollment

90 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Obesity Insufficient Sleep

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

Min Age: 21 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study, called Project SHINE, tests a sleep extension intervention designed specifically for African American adults who sleep 6 hours or less per night and are physically inactive, aiming to improve sleep duration and physical activity levels while reducing obesity-related health disparities in this community. The study first uses in-depth interviews to understand sleep beliefs and cultural factors (Phase 1), then conducts a randomized trial (Phase 2) comparing the sleep intervention against a contact-matched control group. African American adults aged 21–75 with a BMI of 25 or higher who report sleeping 6 hours or less per night and do not meet physical activity guidelines may be eligible. Participation involves completing the 12-week intervention program, which includes behavioral coaching and support for improving sleep habits, along with questionnaires and optional blood draws to look at health biomarkers. This summary was generated by AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALsleep 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.

BEHAVIORALcontact 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.