Culturally tailored lifestyle counseling for pregnant African American women
Official title: A Randomized Control Trial to Improve Metabolic Outcomes in African American Pregnant Women
Run by University of Illinois Chicago · NCT05234125 · Data updated 2026-11-12
This study is testing a special lifestyle counseling program for pregnant African American women to see if it helps them manage their blood sugar and improve their health during pregnancy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | University of Illinois Chicago Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Status | Recruiting |
| Started | August 16, 2022 |
| Main results expected | September 2, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT05234125 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are African American pregnant women aged 16 to 22 weeks who are overweight or obese with a pregravid BMI greater than 25.0 kg/m2.
✕Probably not a fit
Patients with multiple gestations, diagnosed sleep disorders, or those on hypoglycemic medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness of a culturally targeted and individually tailored behavioral intervention designed to improve maternal glucose metabolism among African American women during pregnancy. Participants will be recruited from OB Clinics at the University of Illinois at Chicago and will be randomized into two groups: one receiving the BETTER intervention and the other receiving standard attention control (Birth-Prep). The study focuses on addressing issues related to overweight or obesity, sleep disturbances, and pregnancy complications. By assessing the outcomes of these interventions, the trial seeks to provide insights into improving maternal health in this population.
Why it matters
Potential benefit: If successful, this intervention could lead to improved glucose metabolism and overall health outcomes for pregnant African American women.
How similar studies have gone: Other studies have shown success with culturally tailored interventions in improving health outcomes, suggesting potential for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
University of Illinois at Chicago
Chicago, Illinois, United States Recruiting -
University of Illinois at Chicago
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Bilgay Izci Balserak, PhD — University of Illinois Chicago
- Study coordinator: Bilgay Izci Balserak, PhD
- Email: bilgay@uic.edu
- Phone: 312-996-2718
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.