Time-restricted Eating Among Pregnant Females With Severe Obesity

Not Applicable

Recruiting

• Conditions: Time Restricted Eating; Obesity, Morbid; Pregnancy Weight Gain

• Registration Number: NCT06477120
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

In the United States, severe obesity (body mass index (BMI) ≥ 40.0 kg/m2) affects approximately 10% of females 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.

Detailed Description

Severe obesity is a contributor to adverse perinatal outcomes. The prevalence of severe obesity is on the rise in the United States (U.S.), having increased from 6.4% of the adult population in 2011-2012 to just over 9% of adults in 2017-2018. The prevalence of severe obesity among reproductive age females is approximately 10%. This is an alarming statistic given severe obesity is a predictor of adverse perinatal outcomes including gestational diabetes mellitus, preeclampsia, premature birth (both spontaneous and medically indicated), 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. Existing lifestyle interventions (calorie control/dietary pattern changes/physical activity) have showed modest effects on attenuating excess gestational weight gain and modest effects on perinatal health outcomes among pregnant females with obesity. Time- restricted eating, where an individual simply watches the clock and consumes calories within a particular eating window, is a simple and highly accessible eating pattern that has the potential to minimize gestational weight gain, reduce excess glucose and lipids, and improve metabolic health among pregnant females with severe obesity all of which could translate to improved perinatal health outcomes. Yet there are no clinical trials of time-restricted eating in pregnancy. The investigators aim to test the safety, feasibility, and acceptability of time-restricted eating among 60 pregnant females with severe obesity. The investigators will examine time-restricted eating safety, feasibility and acceptability (8-hr eating window in the 2nd trimester \& 10-hr eating window in the 3rd trimester), and explore its effects on weight, cardiometabolic risk markers and perinatal health outcomes vs. Standard Care. The intervention will begin at \~17 weeks gestational age and continue through admission for labor and delivery. The study will involve weekly meetings with a nutritionist, and research visits at baseline (\~17 weeks gestational age), 27-29 weeks gestational age and 35-37 weeks gestational age as well as monthly check-ins for maternal and fetal health monitoring. Maternal and neonatal data from labor and delivery will also be collected from electronic health records. Glucose will be continuously monitored for 10 days at 20 weeks gestational age and 34 weeks gestational age (optional). The goal of our work is to reduce and prevent adverse perinatal outcomes among pregnant females with severe obesity. Given the relative simplicity of time-restricted eating it can be easily disseminated in clinic demonstrating its strong potential for wide-scale public health impact.

Study Timeline

• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-06-23
• Study First Posted: 2024-06-27
• Study Start: 2024-09-09
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-06
• Last Update Posted: 2025-10-08
• Primary Completion: 2026-08-31
• Study Completion: 2026-11-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maternal Complete Blood Count	Baseline (14-17 weeks gestational age) and monthly through labor and delivery	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
Intervention Acceptability	25-27 weeks gestational age and 35-37 weeks gestational age	Semi-structured interviews
Recruitment Feasibility	From 6 months through 32 months (the funding period is 36 months)	≥ 30% of those approached enroll
Non-stress Test for Fetal Safety	25-27 weeks gestational age and 35-37 weeks gestational age	Measured with a fetal monitor to examine baby's heart rate over time (usually 20 to 30 minutes, but sometimes up to an hour
Maternal Glycemic Health	24-28 weeks gestational age	Oral Glucose Tolerance Test
Fetal Heart Tones	Monthly 16-32 weeks gestational age and twice monthly 33 weeks gestational age up through delivery	Measured during clinical care visits

Secondary Outcome Measures

Name	Time	Method
Fasting Blood Lipids	Baseline (14-17 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age	Cholesterol and triglycerides
Fasting insulin	Baseline (14-17 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age	Measured in serum
Systolic Blood Pressure	Baseline (14-17 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age	Measured with participant in a seated position using an automated cuff
Diastolic Blood Pressure	Baseline (14-17 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age	Measured with participant in a seated position using an automated cuff
Body weight	Baseline (14-17 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age	Body weight in kilograms
Fasting blood glucose	Baseline (14-17 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age	Measured in serum
C-reactive protein	Baseline (14-17 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age	Measured in plasma

Trial Locations

Locations (1)

University of Illinois at Chicago College of Applied Health Sciences; 🇺🇸 Chicago, Illinois, United States