Social Determinants of Sleep and Obesity

Early Phase 1

Recruiting

• Conditions: Insufficient Sleep; Obesity; Physical Inactivity; Sedentary Behavior
• Interventions: Behavioral: Sleep intervention; Behavioral: Contact Control

• Registration Number: NCT05698693
• Lead Sponsor: University of Minnesota

Brief Summary

African American adults sleep less and obtain worse quality sleep compared to the national average, and emerging evidence links inadequate sleep with greater morbidity and mortality from chronic diseases such as diabetes, obesity, and cancer. To address this public health concern, the proposed research seeks to use a multi-method approach to adapt a sleep intervention for African American adults with overweight/obesity not meeting national sleep duration or physical activity recommendations. The overall goal of the project is to reduce cancer and obesity-related health disparities among African Americans.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-16
• Study First Posted: 2023-01-26
• Study Start: 2023-11-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Not meeting Physical Activity Guidelines
• age range: 21 to 65 years
• body mass index range: 25.0 to 40 kg/m2
• average self-reported habitual sleep duration of ≤6 hours
• self-identify as Black or African American.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Sleep intervention	Sleep intervention	The sleep extension intervention is a 4-week intervention consisting of weekly one-on-one contact with the goal of increasing total sleep time by 60 minutes by the end of four weeks conducted by Dr. Wu or a trained counselor. The first session will last 60 minutes and the content will include psychoeducation about the importance of sleep, sleep guidelines and target setting, and basic sleep hygiene. Participants in this condition will receive hardcopy weekly daily diary worksheets, and receive an online version of the sleep daily diary every morning to complete via text messaging. Sessions 2-4 will be between 15-30 minutes where Dr. Wu or a trained counselor will review the sleep diary, problem solve barriers to weekly goals, and sleep promoting behaviors will be reinforced. Material that would be covered during a missed session will be included in the next session the participant attends.
Contact control	Contact Control	The content of the contacts for this intervention condition will be based on the National Center for Healthy Housing's Healthy Homes program, a program designed by the UT School of Public Health. Participants in this condition will meet with Dr. Wu or a trained research staff member. They will meet through Zoom once a week for four sessions to go through each educational module. Sessions will conclude with the development of an action plan for participants. Staff will check in with participants regarding whether they were able to complete the tasks on their action plan, and if not, the reasons for this and potential strategies that may facilitate completion.

Primary Outcome Measures

Name	Time	Method
Feasibility	4 weeks	Feasibility is achieved if intervention adherence is 75% across participants in the intervention group.
Satisfaction	4 weeks post-intervention	Satisfaction is achieved if the average score ≥20 on the Client Satisfaction Questionnaire

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States