What is the BETTER study studying for African American pregnant women?

This study is evaluating a behavioral intervention aimed at improving glucose metabolism during pregnancy in African American women who are overweight or obese. It compares a sleep-focused program with pregnancy-related training to see which better supports maternal health outcomes. The research is led by the University of Illinois at Chicago.

Who may be eligible for this pregnancy clinical trial?

Women who are African American, aged 18 to 40 years, pregnant between 16 and 22 weeks, and have a pre-pregnancy BMI over 25 may be eligible. They must have a singleton pregnancy and receive prenatal care at the study hospital. Please review eligibility criteria for more details.

Is there any cost to participate in this pregnancy clinical trial?

Study-related care, including the study interventions and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 40Years

FEMALE

ID05234125

Trial to Improve Metabolic Health in African American Pregnant Women with Overweight or Obesity Using Sleep and Pregnancy Education Interventions

Led by University of Illinois at Chicago · Updated on 2026-07-09

150

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a behavioral intervention designed to promote better maternal glucose metabolism in African American pregnant women who are overweight or obese. This randomized controlled trial compares a culturally targeted sleep improvement program against an attention control group receiving pregnancy-related training. The study aims to prevent complications related to pregnancy through lifestyle counseling and tailored behavioral strategies. Participants are randomly assigned to one of two groups the BETTER intervention focusing on sleep hygiene and cognitive-behavioral principles, or the Birth-Prep control group providing general training on pregnancy issues. The study includes women between 16 and 22 weeks of gestation and follows them through various assessments during pregnancy to monitor glucose metabolism and sleep quality. Throughout the study, participants undergo baseline and follow-up assessments of fasting glucose, insulin resistance, and glucose response at specified gestational weeks. Sleep quality and duration are self-reported and objectively measured at multiple points. Medical records are reviewed up to three months after delivery. The trial is conducted under triple masking and involves routine monitoring to ensure adherence and safety over the course of pregnancy.

CONDITIONS

Brief Title

Better Lifestyle Counseling for African American Women During Pregnancy

Who Can Participate

Age: 18Years - 40Years

FEMALE

Eligibility Criteria

You may qualify if you...

African American pregnant woman
Between 16 and 22 weeks of gestation
Overweight or obese with pre-pregnancy Body Mass Index greater than 25.0 kg/m2
Singleton pregnancy
Established prenatal care at the University of Illinois Hospital & Health Sciences System
Able to understand, speak, and write in English

You will not qualify if you...

Multiple pregnancies (twins or more)
Night-shift work
Diagnosed sleep disorders
Known fetal chromosomal or anatomical abnormalities
Diagnosed mood disorders
Gestational diabetes diagnosed early in pregnancy
Glycated Hemoglobin (HbA1c) of 6.5% or higher
Use of hypoglycemic medications
Use of stimulant medications or sleeping aids
Active drug abuse or excessive alcohol consumption

Research Team

Bilgay Izci Balserak, PhD

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