Social Determinants of Sleep and Obesity

NCT ID: NCT05698693

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-06-01

Brief Summary

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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

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Conditions

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Insufficient Sleep Physical Inactivity Sedentary Behavior Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

The study uses qualitative interviews (Aim 1; n=10) to inform the adaptation of a sleep intervention for African American adults with overweight/obesity, short sleep, and physical inactivity. The feasibility, satisfaction, and preliminary efficacy will be tested (Aim 2) using a 2-armed randomized control trial (n=80).
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sleep intervention

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Contact Control

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ivan Wu

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ivan Wu, PhD

Role: CONTACT

612-624-2254

Facility Contacts

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Ivan Wu, PhD

Role: primary

612-624-2254

Other Identifiers

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2022LS170

Identifier Type: -

Identifier Source: org_study_id

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