Social Determinants of Sleep and Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698693
• Other study ID #: 2022LS170
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 1, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: November 2023
• Source: University of Minnesota
• Contact: Ivan Wu, PhD
• Phone: 612-624-2254
• Email: wuivan[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Physical Inactivity
• Sedentary Behavior
• Sleep Deprivation

Intervention

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.
• 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.

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