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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility
Satisfaction

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
~150

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,588,885 Total Patients Enrolled
69 Trials studying Obesity
20,659 Patients Enrolled for Obesity
Ivan WuPrincipal InvestigatorUniversity of Minnesota

Media Library

Sleep intervention Clinical Trial Eligibility Overview. Trial Name: NCT05698693 — Phase < 1
Obesity Research Study Groups: Sleep intervention, Contact control
Obesity Clinical Trial 2023: Sleep intervention Highlights & Side Effects. Trial Name: NCT05698693 — Phase < 1
Sleep intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05698693 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals, over the age of 70 years, eligible for this medical experiment?

"This research project has set the age limit at 21 to 65, with a total of 214 trials for minors and 669 studies dedicated to seniors."

Answered by AI

Is it possible for participants to enroll in this investigation right now?

"According to clinicaltrials.gov, this experiement is not currently recruiting candidates. It was originally posted on January 27th 2023 and last modified on the 16th of the same month. Sadly, no new participants can join this particular trial; however 1066 other trials are actively seeking volunteers at present."

Answered by AI

To whom is this clinical research opportunity available?

"This trial is presently recruiting 90 individuals suffering from sleep deprivation, aged between 21 and 65. Notably, all candidates must meet the following requirements: not meeting Physical Activity Guidelines; BMI range of 25 to 40 kg/m2; average self-reported habitual sleep duration of no more than 6 hours; identifying as Black or African American."

Answered by AI

Who else is applying?

What site did they apply to?
University of Minnesota
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Social Determinants of Sleep and Obesity
2023. "Social Determinants of Sleep and Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05698693.
All > Sleep Deprivation
~60 spots leftby Jun 2025
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