Recruiting

Lifestyle Counseling

Sponsor:

University of Illinois at Chicago

Code:

NCT05234125

Conditions

Overweight or Obesity

Pregnancy Related

Sleep Disturbances

Sleep Hygiene

Pregnancy Complications

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Better

Birth Prep

Study Details

Brief summary:

The purpose of this randomized controlled trial is to establish the effectiveness of a culturally targeted and individually tailored behavioral intervention to promote maternal glucose metabolism in African American women.

Conditions

Overweight or Obesity

Pregnancy Related

Sleep Disturbances

Sleep Hygiene

Pregnancy Complications

Study ID

NCT05234125

Start date

Aug 16, 2022

Status verified date

May, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Sep 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Intervention arm

Sleep hygiene practices and cognitive-behavioral principles

placebo comparator: Attention control

Training about pregnancy issues

Interventions

Better

It is a nonpharmacologic sleep intervention to improve maternal glucose metabolism in African American Pregnant Women (AAPW). Sleep BETTER is composed of sleep hygiene practices and cognitive-behavioral principles.

Birth Prep

The intervention involves training about pregnancy-related issues, and follow up

Primary outcome measure

  • Fasting Glucose at baseline [ Time Frame: 16-22 Gestational Weeks (GWs) ]
  • Fasting Glucose [ Time Frame: 28-32 Gestational Weeks (GWs) ]

Central Contacts and Locations

Central contacts

Bilgay Izci Balserak, PhD

312-996-2718bilgay@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 606012

Contacts

Bilgay Izci B Balserak, PhD

13129962718bilgay@uic.edu

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Bilgay Izci Balserak, PhD

312-996-2718

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jul 9, 2026

Last verified

May, 2026

Keywords

  • Sleep, Pregnancy, Intervention, glucose metabolism,

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-07-09.