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Sleep Intervention for Obesity

Phase < 1

Recruiting

Led By Ivan Wu

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age range: 21 to 65 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial seeks to reduce health disparities among African Americans by using a multi-method approach to improve sleep duration and quality. This could reduce morbidity & mortality from diabetes, obesity, & cancer.

Who is the study for?

This trial is for African American adults aged 21-65 with a BMI of 25.0 to 40 kg/m2 who aren't very active, sleep ≤6 hours on average, and are not meeting physical activity guidelines. It's not for those with certain organ disorders, pregnant or recent mothers, or those with infants under one year old in the household.

What is being tested?

The study aims to adapt a sleep intervention for African American adults who are overweight/obese and don't get enough sleep or exercise. The goal is to improve their health by reducing risks related to cancer and obesity through better sleep habits.

What are the potential side effects?

Since this trial focuses on behavioral interventions like improving sleep patterns rather than medication, side effects may include changes in mood or energy levels due to alterations in sleeping habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 21 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility

Satisfaction

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sleep interventionExperimental Treatment1 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 II: Contact controlActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sleep intervention

2011

N/A

~210

0 / 1Eligibility criteria met