Time-restricted Eating Among Pregnant Females With Severe Obesity
NCT Number: NCT06477120
Acronym: TRE-Preg
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity, Morbid|Time Restricted Eating|Pregnancy Weight Gain
Interventions: BEHAVIORAL: Time Restricted Eating
Sponsor: University of Illinois at Chicago
Sex: FEMALE
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2027-02
Locations: University of Illinois at Chicago College of Applied Health Sciences, Chicago, Illinois, 60612, United States

Summary:
In the United States, severe obesity (body mass index (BMI) ≥ 40.0 kg/m2) affects approximately 10% of females of reproductive age with Black females disproportionately burdened (16%). 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 - outcomes that also disproportionately affect Black females. 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.

Primary Outcome Measures: Maternal Glycemic Health, Oral Glucose Tolerance Test, 24-28 weeks gestational age|Recruitment Feasibility, ≥ 30% of those approached enroll, From 6 months through 32 months (the funding period is 36 months)|Fetal Heart Tones, Measured during clinical care visits, Monthly 16-32 weeks gestational age and twice monthly 33 weeks gestational age up through delivery|Maternal Complete Blood Count, A laboratory test that measures the quantity and quality of blood cells and other components: Red blood cells (RBCs), White blood cells (WBCs), Platelets (thrombocytes), Hemoglobin, and Hematocrit from a Blood Sample, Baseline (14-17 weeks gestational age) and monthly through labor and delivery|Non-stress Test for Fetal Safety, Measured with a fetal monitor to examine baby's heart rate over time (usually 20 to 30 minutes, but sometimes up to an hour, 25-27 weeks gestational age and 35-37 weeks gestational age|Intervention Acceptability, Semi-structured interviews, 25-27 weeks gestational age and 35-37 weeks gestational age
Secondary Outcome Measures: Body weight, Body weight in kilograms, Baseline (14-17 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age|Fasting blood glucose, Measured in serum, Baseline (14-17 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age|Fasting insulin, Measured in serum, Baseline (14-17 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age|Fasting Blood Lipids, Cholesterol and triglycerides, Baseline (14-17 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age|C-reactive protein, Measured in plasma, Baseline (14-17 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age|Systolic Blood Pressure, Measured with participant in a seated position using an automated cuff, Baseline (14-17 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age|Diastolic Blood Pressure, Measured with participant in a seated position using an automated cuff, Baseline (14-17 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age