Recruiting

Time-Restricted Eating

Sponsor:

University of Illinois at Chicago

Code:

NCT06477120

Conditions

Obesity, Morbid

Time Restricted Eating

Pregnancy Weight Gain

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Accepted

Interventions

Time Restricted Eating

Study Details

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.

Conditions

Obesity, Morbid

Time Restricted Eating

Pregnancy Weight Gain

Study ID

NCT06477120

Start date

Sep 9, 2024

Status verified date

Jan, 2026

Completion date

Nov 29, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Accepted

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
  • 14 - < = 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

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.

Primary outcome measure

  • Recruitment Feasibility [ Time Frame: From 6 months through 32 months (the funding period is 36 months) ]
  • Trial safety - Maternal Complete Blood Count [ Time Frame: Baseline (14-20 weeks gestational age) and monthly through labor and delivery, about 6 months ]
  • Trial safety - Non-stress Test for Fetal Safety [ Time Frame: 29-31 weeks gestational age and 35-37 weeks gestational age ]
  • Intervention acceptability [ Time Frame: 25-27 weeks gestational age and 35-37 weeks gestational age ]
  • Research visit feasibility [ Time Frame: Baseline, 25-27 weeks gestational age and 35-37 weeks gestational age ]
  • Intervention (TRE) session feasibility [ Time Frame: Weekly from baseline through labor and delivery, about 6 months ]
  • TRE adherence [ Time Frame: Daily from enrollment to labor and delivery (TRE arm only), about 6 months ]
  • Trial safety - Maternal health checks [ Time Frame: Weekly from baseline to labor and delivery, about 6 months, % and n for health events reported by study arm ]
  • Trial safety - Maternal outcomes [ Time Frame: Labor and delivery ]
  • Trial safety - Neonatal outcomes [ Time Frame: Labor and delivery ]
  • Trial Retention [ Time Frame: 35-37 week gestational age ]

Central Contacts and Locations

Central contacts

Lisa Tussing-Humphreys, PhD, RD

312-355-5521tussing@uic.edu

Mary Dawn Koenig, PhD, RN

(312) 996-7942marydh@uic.edu

Locations

University of Illinois at Chicago College of Applied Health Sciences

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Lisa Tussing-Humphreys, PhD, MS, RD

312-355-5521tussing@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-01-23.