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Sleep program aims to reduce pregnancy risks in african american women

NCT ID NCT05234125

Disease control Sponsor: University of Illinois at Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests a culturally tailored sleep program called Sleep BETTER for African American pregnant women who are overweight or obese. The program combines sleep hygiene tips and cognitive-behavioral techniques to help improve glucose metabolism and reduce pregnancy complications. Participants are randomly assigned to either the sleep program or a standard pregnancy education group, and their blood sugar and insulin levels are tracked.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sleep BETTER behavioral sleep intervention
What this could lead to
If effective, this program could offer a simple, non-drug way to improve metabolic health and reduce pregnancy complications in African American women.
What could go wrong
This is a small, early-stage trial. The intervention may not significantly improve glucose levels, and results may not apply to other populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * African American pregnant woman. * Women between 16 and 22 GWs. * Overweight or obese - pregravid Body Mass Index \>25.0 kg/m2. * Singleton gestation. * Established prenatal care at The University of Illinois Hospital \& Health Sciences. * System Obstetric (UIHHSS' OB) clinics. Able to understand, speak and write in English. Exclusion Criteria: * Multiple gestations. * Night-shift work. * Diagnosed sleep disorders. * Known fetal chromosomal or anatomical abnormalities. * Diagnosed mood disorders. * Gestational diabetes in early pregnancy. * Glycated Hemoglobin (HbA1c) ≥ 6.5%. * Hypoglycemic medications. * Stimulant medication or taking a sleeping aid. * Active drug abuse/excessive alcohol intake.

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Conditions

The condition(s) this trial relates to.

Motor Activity Obesity obesity disorder Overweight Parasomnias pregnancy disorder sleep disorder Sleep Hygiene Stress, Psychological

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

African americans Disparities in pregnancy complications Diversity Exercise Fitness trackers Overweight or obesity Pregnancy complications Pregnancy related Sleep disparities Sleep disturbances Sleep hygiene Stress, psychological

How to take part

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  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of Illinois at Chicago

    RECRUITING

    Chicago, Illinois, 606012, United States

  • University of Illinois at Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

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