RecruitingNot Applicable

Time-restricted Eating Among Pregnant Females With Severe Obesity

United States60 participantsStarted 2024-09-09

Plain-language 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.

Who can participate

Age range18 Years – 44 Years

SexFEMALE

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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

What they're measuring

Recruitment Feasibility

Timeframe: From 6 months through 32 months (the funding period is 36 months)

Trial safety - Maternal Complete Blood Count

Timeframe: Baseline (14-20 weeks gestational age) and monthly through labor and delivery, about 6 months

Trial safety - Non-stress Test for Fetal Safety

Timeframe: 29-31 weeks gestational age and 35-37 weeks gestational age

Intervention acceptability

Timeframe: 25-27 weeks gestational age and 35-37 weeks gestational age

Research visit feasibility

Timeframe: Baseline, 25-27 weeks gestational age and 35-37 weeks gestational age

Intervention (TRE) session feasibility

Timeframe: Weekly from baseline through labor and delivery, about 6 months

TRE adherence

Timeframe: Daily from enrollment to labor and delivery (TRE arm only), about 6 months

Trial safety - Maternal health checks

Trial details

NCT IDNCT06477120

SponsorUniversity of Illinois at Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

Contact for this trial

Lisa Tussing-Humphreys, PhD, RD

312-355-5521 tussing@uic.edu

View on ClinicalTrials.gov More Obesity, Morbid trials