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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06226077
• Other study ID #: 2022LS170 (B)
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2024
• Source: University of Minnesota
• Contact: Rachel Price, MPH
• Phone: 612-624-2254
• Email: price919[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Sleep Deprivation

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the sleep intervention	feasibility is defined as 75% intervention attendance (3/4 sessions)	10 weeks
Primary	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