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/41254328/Actively Recruiting
Led by University of Illinois at Chicago · Updated on 2026-07-09
150
Participants Needed
2
Research Sites
17 weeks
Total Duration
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
Better Lifestyle Counseling for African American Women During Pregnancy
B
Bilgay Izci Balserak, PhD
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University of Illinois at Chicago
Lead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Sleep BETTER (behavioral sleep counseling) | Attention Control (pregnancy-related education: Birth Prep) |
|---|---|---|
| What it is | A behavioral sleep hygiene and cognitive-behavioral counseling program (Sleep BETTER) for pregnant African American women with overweight or obesity. The program aims to improve sleep habits and incorporate cognitive-behavioral strategies to support healthy maternal glucose levels. | An educational program about pregnancy-related topics (Birth Prep), with similar session frequency and follow-up as Sleep BETTER, but without the focused sleep or cognitive-behavioral counseling elements. |
| Role in the trial | Investigational intervention being tested for its ability to improve sleep, reduce stress, and support healthier glucose metabolism during pregnancy. | Serves as an active attention control, providing general pregnancy education to match the interaction and engagement level of Sleep BETTER but without the specific sleep focus. |
| Primary use or goal | To help pregnant African American women with overweight or obesity improve their sleep quality, with the goal of preventing abnormal glucose metabolism and reducing pregnancy complications related to poor sleep. | To provide pregnancy education as an active comparator. Does not involve sleep or cognitive counseling. |
| How it is given or performed | Participants attend structured sessions using sleep hygiene education and cognitive-behavioral strategies. Content is tailored to sleep needs during pregnancy. | Participants receive similarly timed sessions on pregnancy care topics with follow-up support. |
| Evidence status / current clinical understanding | This is an ongoing clinical trial; results are not yet available. However, research shows that poor sleep quality in African American pregnant women is associated with increased insulin resistance and metabolic risk. | Serves as an active comparator to control for participant attention and contact. Standard pregnancy education alone has not been proven to specifically improve sleep quality or glucose metabolism among African American pregnant women with overweight or obesity. |
| Important limitations | The effectiveness and feasibility of a dedicated behavioral sleep program for African American pregnant women with overweight or obesity is not yet established. The program was specifically designed for this population, so results may not generalize to others or to routine prenatal care settings. | The attention control (Birth Prep) group matches session frequency but does not address sleep, so may not influence sleep or metabolic health. Findings may not reflect usual care, since both arms offer increased contact beyond standard prenatal visits. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Ghada Abu Irsheed, Alana Steffen, Laurie Quinn...
https://pubmed.ncbi.nlm.nih.gov/41254328/University of Illinois at Chicago
Lead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborating Sponsor