Study of Time-Restricted Eating During Pregnancy in Women with Severe Obesity to Improve Maternal and Baby Health

What this Trial Is About

Severe obesity affects about 15% of women of reproductive age in the United States and is linked to serious pregnancy complications such as gestational diabetes, pre-eclampsia, premature birth, fetal death, birth defects, and increased maternal mortality. This research evaluates time-restricted eating during the second and third trimesters of pregnancy to explore its effects on maternal weight and perinatal health outcomes compared to standard clinical care. The study aims to test the safety, feasibility, and acceptability of time-restricted eating for pregnant females with severe obesity. Participants will be randomized into two groups one following a time-restricted eating pattern with an 8-hour eating window daily in the second trimester 11am to 7pm and a 10-hour window in the third trimester 10am to 8pm, abstaining from caloric foods outside these windows. The other group will receive enhanced standard care without diet counseling. The intervention starts between 14 and 20 weeks gestation and continues until labor and delivery. Weekly meetings with a nutritionist and regular research visits are part of the study schedule. Participants will attend research visits at baseline 17 weeks, 27-29 weeks, and 35-37 weeks gestational age, with monthly health check-ins for both mother and fetus. Maternal and neonatal data from labor and delivery will be collected from medical records. Optional continuous glucose monitoring for 10 days at 20 and 34 weeks is available. Researchers will assess recruitment feasibility, safety, adherence to the eating window, maternal weight, cardiometabolic markers, and perinatal outcomes over approximately six months.

Time-restricted Eating Among Pregnant Females With Severe Obesity