Culturally tailored lifestyle counseling for pregnant African American women
A Randomized Control Trial to Improve Metabolic Outcomes in African American Pregnant Women
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05234125 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with multiple gestations, diagnosed sleep disorders, or those on hypoglycemic medications may not benefit from this study.
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 performed: Other studies have shown success with culturally tailored interventions in improving health outcomes, suggesting potential for this approach.
Eligibility criteria
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 this trial is running
Chicago, Illinois and 1 other locations
- 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 at Chicago
- Study coordinator: Bilgay Izci Balserak, PhD
- Email: bilgay@uic.edu
- Phone: 312-996-2718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.