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Time-restricted Eating Among Pregnant Females With Severe Obesity

NCT06477120 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-23

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

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

    collaborator NIH

  • University of Illinois at Chicago

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2026-08-31
Completion
2026-11-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06477120 on ClinicalTrials.gov