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Time-restricted Eating for Pregnant Females with Severe Obesity

This study is looking at whether time-restricted eating can help pregnant women with severe obesity. Severe obesity (a body mass index or BMI of 35.0 kg/m2 or higher) can lead to health problems for both mother and baby, like gestational diabetes and premature birth. Participants will be asked to eat within a specific 8-hour or 10-hour window each day during their second and third trimesters, and avoid food and sugary drinks outside of that window. The study aims to see if this eating pattern is safe and practical for pregnant women, by monitoring things like blood counts and fetal well-being. You might be able to join if you are a woman between 18 and 44 years old, have a BMI between 35 and 60, are pregnant with one baby, and are between 14 and 20 weeks pregnant.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 60 participants.
What's involved
You would have blood tests at the beginning of the study and monthly until delivery. Fetal non-stress tests would be done at 29-31 weeks and 35-37 weeks of pregnancy.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored from 6 months through 32 months, with specific tests continuing until labor and delivery (about 6 months).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06477120

Time-restricted Eating Among Pregnant Females With Severe Obesity

Recruiting
NAAges 18–44InterventionalPrevention
University of Illinois at Chicago
~60 participants
Updated 2026-01-23 on ClinicalTrials.gov
What's tested:Time Restricted Eating

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment Feasibility
Measured over From 6 months through 32 months (the funding period is 36 months)
+10 more outcomes measured

Conditions

Obesity, Morbid
Time Restricted Eating
Pregnancy Weight Gain

Explore related trials

Obesity

Where it's being run

1 sites across 1 states
Illinois1

Who to contact

Lisa Tussing-Humphreys, PhD, RD
[email protected]
312-355-5521
Email the study team

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Eligibility criteria

Inclusion

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

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 this trial measures

  • Recruitment FeasibilityFrom 6 months through 32 months (the funding period is 36 months)

    ≥ 30% of those approached enroll

  • Trial safety - Maternal Complete Blood CountBaseline (14-20 weeks gestational age) and monthly through labor and delivery, about 6 months

    % and n with abnormal results by study arm

  • Trial safety - Non-stress Test for Fetal Safety29-31 weeks gestational age and 35-37 weeks gestational age

    Measured with a fetal monitor to examine baby's heart rate over time (usually 20 to 30 minutes, but sometimes up to an hour) % and n with abnormal results by study arm

  • Intervention acceptability25-27 weeks gestational age and 35-37 weeks gestational age

    Semi-structured interviews

  • Research visit feasibilityBaseline, 25-27 weeks gestational age and 35-37 weeks gestational age

    Number of data collection visits completed with \>=80% completed at each timepoint and completeness of data

  • Intervention (TRE) session feasibilityWeekly from baseline through labor and delivery, about 6 months

    Number and % of intervention sessions completed by TRE participants

  • TRE adherenceDaily from enrollment to labor and delivery (TRE arm only), about 6 months

    Response rate to daily text message regarding eating start and stop time to determine adherence to the eating window goal is \>= 80% adherence on days reported

  • Trial safety - Maternal health checksWeekly from baseline to labor and delivery, about 6 months, % and n for health events reported by study arm

    Weekly maternal health checks via videoconference in TRE and control group that is verified with electronic health record

  • Trial safety - Maternal outcomesLabor and delivery

    Data obtained from the participant's electronic health record (gestational age at delivery, gestational diabetes, gestational hypertension, preeclampsia, c-section, spontaneous pre-term birth, iron deficiency anemia) % and n with abnormal results by study arm

  • Trial safety - Neonatal outcomesLabor and delivery

    Data obtained from the participant's electronic health record (small or large for gestational age, neonatal intensive care admission, jaundice, APGAR score) % and n with abnormal results by study arm

  • Trial Retention35-37 week gestational age

    n and % of women retained through the final in-person data collection with \>= 80% retained