Actively Recruiting

Phase Not Applicable
Age: 18Years - 44Years
FEMALE
Healthy Volunteers
NCT06477120

Time-restricted Eating Among Pregnant Females With Severe Obesity

Led by University of Illinois at Chicago · Updated on 2026-01-23

60

Participants Needed

1

Research Sites

115 weeks

Total Duration

On this page

Sponsors

U

University of Illinois at Chicago

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Time-restricted Eating Among Pregnant Females With Severe Obesity

Who Can Participate

Age: 18Years - 44Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Deemed medically high risk
  • Multiple pregnancy (e.g., twins)
  • Type 1 or 2 diabetes mellitus
  • Early gestational diabetes (diagnosed at <= 17 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Illinois at Chicago College of Applied Health Sciences

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

L

Lisa Tussing-Humphreys, PhD, RD

CONTACT

M

Mary Dawn Koenig, PhD, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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