Social Determinants of Sleep and Obesity

Social Determinants of Sleep and Obesity: Culturally Informing a Sleep Extension Intervention for African American Adults

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Sedentary Behavior; Insufficient Sleep; Physical Inactivity
• Intervention / Treatment: Behavioral: Sleep intervention; Behavioral: Contact Control

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: Contact Control; This is healthy homes intervention.The program provides education on healthy homes, provide advice on specific healthy homes problems, and recommend actions to be taken by families, landlords, and community members.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Ivan Wu, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2026

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Sleep Wake Disorders; Overweight; Dyssomnias; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Sleep Deprivation; Sedentary Behavior
• Other Study ID Numbers: 2022LS170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No