Time-restricted Eating Among Pregnant Females With Severe Obesity

NCT ID: NCT06477120

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-09
• Study Completion Date: 2026-11-29

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.

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 between 14 - <20 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.

Conditions

Obesity, Morbid; Time Restricted Eating; Pregnancy Weight Gain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Time-restricted eating

Participants randomized to the time-restricted eating arm will be instructed to eat ad libitum during an 8-hr window daily 11am - 7pm in the 2nd trimester and 10-hr eating window from 10am - 8pm in the 3rd trimester and abstain from caloric foods and beverages for the remaining 14-16 hours. During the eating window there will be no restrictions on types or quantities of foods consumed. Moreover, participants will not be required to monitor calorie intake during the ad libitum eating period. During the fasting period, participants will be encouraged to drink plenty of water and will be allowed to consume calorie-free beverages.

Group Type: EXPERIMENTAL

Time Restricted Eating

Intervention Type: BEHAVIORAL

The time-restricted eating arm will be instructed to eat ad libitum during an 8-hr window daily (10am - 6pm OR 11am - 7pm) in the 2nd trimester and 10-hr eating window from (9am - 7pm OR 10am - 8pm) in the 3rd trimester and abstain from caloric foods and beverages for the remaining 14-16 hours.

Enhanced Standard Care

The standard care arm will not receive diet-related counseling. Participants will meet with study staff weekly to record health changes and to transmit weight through the text messaging platform. The remote videoconferencing visits will occur at the same day and time each week. Standard care participants will attend the in-person research data collection visits. Participants will be asked to maintain current (baseline) level of physical activity throughout the intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Time Restricted Eating

The time-restricted eating arm will be instructed to eat ad libitum during an 8-hr window daily (10am - 6pm OR 11am - 7pm) in the 2nd trimester and 10-hr eating window from (9am - 7pm OR 10am - 8pm) in the 3rd trimester and abstain from caloric foods and beverages for the remaining 14-16 hours.

Intervention Type: BEHAVIORAL

Eligibility 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
• < = 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Lisa Tussing-Humphreys

Professor, Kinesiology and Nutrition, PhD, MS, RD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Illinois at Chicago College of Applied Health Sciences

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lisa Tussing-Humphreys, PhD, RD

Role: CONTACT

Phone: 312-355-5521

Email: tussing@uic.edu

Mary Dawn Koenig, PhD, RN

Role: CONTACT

Phone: (312) 996-7942

Email: marydh@uic.edu

Facility Contacts

Lisa Tussing-Humphreys, PhD, MS, RD

Role: primary

Other Identifiers

5R01DK136085-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024-0138

Identifier Type: -

Identifier Source: org_study_id