Life sciences · Interventional Study
ClinicalTrials.gov · October 14, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06477120). This is a study registration, not published results. Lead sponsor: University of Illinois at Chicago. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Obesity, Morbid, Time Restricted Eating, Pregnancy Weight Gain. Interventions: BEHAVIORAL: Time Restricted Eating. Primary outcome measures: Recruitment Feasibility , From 6 months through 32 months (the funding period is 36 months); Trial safety - Maternal Complete Blood Count , Baseline (14-20 weeks gestational age) and monthly through labor and delivery, about 6 months; Trial safety - Non-stress Test for Fetal Safety , 29-31 weeks gestational age and 35-37 weeks gestational age; Intervention acceptability , 25-27 weeks gestational age and 35-37 weeks gestational age; Research visit feasibility , Baseline, 25-27 weeks gestational age and 35-37 weeks gestational age; Intervention (TRE) session feasibility , Weekly from baseline through labor and delivery, about 6 months; TRE adherence , Daily from enrollment to labor and delivery (TRE arm only), about 6 months; Trial safety - Maternal health checks , Weekly from baseline to labor and delivery, about 6 months, % and n for health events reported by study arm; Trial safety - Maternal outcomes , Labor and delivery; Trial safety - Neonatal outcomes , Labor and delivery; Trial Retention , 35-37 week gestational age. Brief summary: In the United States, a body mass index (BMI) of at least 35.0 kg/m2 affects about 15% of women of reproductive age. Severe obesity is a significant predictor of adverse perinatal outcomes including gestational diabetes mellitus, pre-eclampsia, premature birth, and at its most severe, fetal death, birth defects and a three-fold greater risk of maternal mortality. Observational studies suggest weight maintenance and even modest body fat loss and altering the maternal metabolic milieu (availability of glucose and lipids) in the gestational period may be important to reducing perinatal health risks among pregnant females with severe obesity. The proposed research aims to assess time-restricted eating in the 2nd and 3rd trimesters of pregnancy to explore the effects on maternal weight, and perinatal health outcomes compared to standard clinical care.