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Social Determinants of Sleep and Obesity

Primary Purpose

Insufficient Sleep, Physical Inactivity, Sedentary Behavior

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sleep intervention
Contact Control
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insufficient Sleep

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sleep intervention

Contact control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility
Feasibility is achieved if intervention adherence is 75% across participants in the intervention group.
Satisfaction
Satisfaction is achieved if the average score ≥20 on the Client Satisfaction Questionnaire

Secondary Outcome Measures

Full Information

First Posted
January 4, 2023
Last Updated
September 18, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05698693
Brief Title
Social Determinants of Sleep and Obesity
Official Title
Social Determinants of Sleep and Obesity: Culturally Informing a Sleep Extension Intervention for African American Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insufficient Sleep, Physical Inactivity, Sedentary Behavior, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Factorial Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Contact control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep intervention
Intervention Description
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
Intervention Name(s)
Contact Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility
Description
Feasibility is achieved if intervention adherence is 75% across participants in the intervention group.
Time Frame
4 weeks
Title
Satisfaction
Description
Satisfaction is achieved if the average score ≥20 on the Client Satisfaction Questionnaire
Time Frame
4 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan Wu, PhD
Phone
612-624-2254
Email
wuivan@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Wu
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Wu, PhD
Phone
612-624-2254
Email
wuivan@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Social Determinants of Sleep and Obesity

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