Poor Sleep Environment and Increased Insulin Resistance in Black/African American Pregnant Women: A Cross-Sectional Study.
Ghada Abu Irsheed, Alana Steffen, Laurie Quinn...
https://pubmed.ncbi.nlm.nih.gov/41254328Actively Recruiting
Phase Not Applicable
Age: 18Years - 40Years
FEMALE
ID05234125
A Randomized Control Trial to Improve Metabolic Outcomes in African American Pregnant Women
Led by University of Illinois at Chicago · Updated on 2025-04-04
150
Participants Needed
2
Research Sites
25 weeks
Total Duration
On this page
Sponsors
U
University of Illinois at Chicago
Lead Sponsor
N
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a behavioral intervention designed to improve glucose metabolism during pregnancy in African American women who are overweight or obese. This randomized controlled trial compares a culturally tailored sleep-focused intervention to an attention control group to see how each affects maternal metabolic health. The study aims to address disparities in pregnancy complications among this population by focusing on sleep hygiene and cognitive-behavioral techniques. Participants are randomly assigned to one of two groups: the BETTER intervention, which includes sleep hygiene practices and cognitive-behavioral principles, or the Birth-Prep control group, which involves training about pregnancy-related topics and follow-up. The trial takes place at the University of Illinois health clinics and monitors participants from 16 to 22 weeks of gestation through later pregnancy stages. During the study, participants undergo baseline and follow-up assessments of fasting glucose and insulin resistance between 16 and 36 weeks of gestation. Sleep quality and duration are also evaluated subjectively and objectively at multiple time points. Medical records are reviewed up to three months post-delivery to capture pregnancy outcomes. The trial includes regular monitoring and data collection to assess the effects of the interventions on maternal glucose metabolism and sleep patterns.
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 BMI greater than 25.0 kg/m2
- Singleton pregnancy
- Receiving prenatal care at the University of Illinois Hospital & Health Sciences
- Able to understand, speak, and write in English
You will not qualify if you...
- Multiple pregnancies (twins or more)
- Working night shifts
- Diagnosed sleep disorders
- Known fetal chromosomal or anatomical abnormalities
- Diagnosed mood disorders
- Gestational diabetes diagnosed early in pregnancy
- Hemoglobin A1c level 6.5% or higher
- Using hypoglycemic medications
- Taking stimulant or sleep aid medications
- Active drug abuse or excessive alcohol intake
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - From 16 to 36 weeks of gestation
Participants receive either sleep hygiene practices and cognitive-behavioral principles or training about pregnancy-related issues as part of the behavioral intervention during pregnancy.
Multiple visits during pregnancy for intervention and assessments
Follow-up
Duration - Up to 3 months post-delivery
Participants have medical records collected post-delivery to assess outcomes up to 3 months after the intervention.
Data collection from medical records; no additional participant visits required
Trial Site Locations
Total: 2 locations
1
University of Illinois at Chicago
Chicago, Illinois, United States, 606012
Actively Recruiting
2
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
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Research Team
B
Bilgay Izci Balserak, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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