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

NCT06226077 | Recruiting Phase 1

• 1 other identifier: 2022LS170 (B)
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Insufficient Sleep

Outcome Measures

Primary Outcomes (2)

• Feasibility of the sleep intervention

  feasibility is defined as 75% intervention attendance (3/4 sessions)

  10 weeks

• Satisfaction with the sleep intervention

  satisfaction is defined as Client Satisfaction Questionaire score \>=20, range 8-32, with higher scores indicating higher satisfaction.

  10 weeks

Study Arms (2)

sleep extension intervention arm

EXPERIMENTAL

sedentary and short sleep (=\<6 hrs/night) African American adults with overweight/obesity randomized to the sleep extension intervention.

Behavioral: sleep extension intervention

education contact control arm

ACTIVE COMPARATOR

sedentary and short sleep (=\<6 hrs/night) African American adults with overweight/obesity randomized to contact control intervention.

Behavioral: contact control intervention

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.

sleep extension intervention arm

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.

education contact control arm

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Sleep Deprivation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Study Officials

• Ivan Wu, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Price, MPH

CONTACT

612-624-2254; price919@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention is a 6-week (4-week intervention, 1- week pre/post actigraphy measurement) 2-armed randomized control trial with the sleep extension intervention in one arm, and then an education contact control in the second arm.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 26, 2024
• Study Start: October 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)