Improved Sleep for Obesity and Diabetes Risk Reduction

Overseen By Silvana Pannain, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Drugs, Nicotine, Alcohol, Caffeine

Disqualifiers: Sleep disorders, Diabetes, Endocrine dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

18 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to identify an intervention that improves sleep health and consequently metabolic health by examining whether sleep extension or enforced regularity in short sleepers will have beneficial effects on diabetes and obesity risk.

Research Team

Erin Hanlon, Ph.D.

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for African American adults aged 21-50 who are overweight with a BMI of 25 to 30 and usually sleep less than 7 hours at night. Participants should have the potential to sleep more if they had the time.

Inclusion Criteria

I am between 22 and 50 years old.

I usually sleep less than 7 hours a night.

I am African American.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline/Habitual Sleep Assessment

Assessment of sleep duration, food intake, hunger/appetite ratings, reward-related eating, daily interstitial glucose, resting metabolic rate, insulin sensitivity, and glucose tolerance

1 week

1 visit (in-person)

Intervention

Participants are randomized to either sleep extension or sleep regularity intervention for 14 days

2 weeks

Daily monitoring (remote)

Post-Intervention Assessment

Reassessment of food intake, hunger/appetite ratings, reward-related eating, daily interstitial glucose, resting metabolic rate, insulin sensitivity, and glucose tolerance

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in sleep and metabolic health outcomes

4 weeks

Treatment Details

Interventions

• Sleep Extension
• Sleep Regularity

Trial Overview The study is testing two approaches to improve sleep health: one group will try sleeping longer (sleep extension), while another will focus on keeping a consistent sleep schedule (sleep regularity). The aim is to see if these methods can lower diabetes and obesity risk.

Participant Groups

Group I: Sleep Regularity Experimental Treatment 1 Intervention

Participants in the sleep regularity group will have consistent bedtimes (within 30min).

Group II: Sleep Extension Experimental Treatment 1 Intervention

Participants that are in the sleep extension group will have their time in bed extended by 2 hours. This can include going to bed earlier and/or waking up later.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+