Time-restricted eating for pregnant women with severe obesity
A Pilot Study of Time-restricted Eating Among Pregnant Females With Severe Obesity
This study is testing if time-restricted eating during pregnancy can help women with severe obesity manage their weight and improve health outcomes for themselves and their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06477120 on ClinicalTrials.gov |
What this trial studies
This research explores the effects of time-restricted eating during the second and third trimesters of pregnancy on maternal weight and perinatal health outcomes in women with severe obesity. The study targets pregnant females with a body mass index (BMI) of 40.0 kg/m2 or higher, aiming to assess whether this eating pattern can reduce gestational weight gain and improve health outcomes compared to standard clinical care. By focusing on a simple and accessible dietary approach, the study seeks to address the rising prevalence of severe obesity and its associated risks during pregnancy, particularly among Black females who are disproportionately affected. Participants will be monitored for changes in weight and metabolic health throughout the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant females aged 18-44 with a BMI between 40.0 and 50 kg/m2 who are within 17 weeks of gestation.
Not a fit: Patients who are medically high risk, have multiple pregnancies, or have diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved maternal and fetal health outcomes for pregnant women with severe obesity.
How similar studies have performed: While time-restricted eating is a relatively novel approach in this context, existing lifestyle interventions have shown modest effects on managing weight and improving perinatal health outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Female based on sex assigned at birth * Preconception body mass index (BMI) 35.0 - 60 kg/m2 * Singleton pregnancy * Age 18-44 years old * 14 - \< = 20 weeks gestational age * Fluency in English to provide consent and complete study procedures * Ability to provide informed consent * Cleared by study doctor and the obstetrician/mid-wife provider to participate * Access to a smartphone to complete intervention procedures Exclusion criteria: * Deemed medically high risk * Multiple pregnancy (e.g., twins) * Type 1 or 2 diabetes mellitus * Early gestational diabetes (diagnosed at \< = to17 weeks gestational age through an oral glucose tolerance test) * Currently eating ≤ 12 hours daily * Autoimmune disorder (e.g., rheumatoid arthritis) * iron deficiency anemia * Inflammatory bowel disease * Previous spontaneous preterm birth * History of bariatric surgery * Night shift work * Currently incarcerated * Eating disorder
Where this trial is running
Chicago, Illinois
- University of Illinois at Chicago College of Applied Health Sciences — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Lisa Tussing-Humphreys, PhD, RD
- Email: tussing@uic.edu
- Phone: 312-355-5521
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.