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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Rachel Price, MPH
price919@umn.edu
612-624-2254
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 90
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov