Obesity, MorbidTRE-PregNCT06477120
Time-restricted Eating Among Pregnant Females With Severe Obesity
A study testing Time Restricted Eating in people with Obesity, Morbid and Time Restricted Eating, run by University of Illinois at Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid, Time Restricted Eating, Pregnancy Weight Gain
- What is being tested?
- Time Restricted Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2024to 29 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 13Show fewer
- iron deficiency anemia
- Inflammatory bowel disease
- Previous spontaneous preterm birth
- History of bariatric surgery
- Night shift work
- Currently incarcerated
- Eating disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago College of Applied Health Sciences
Chicago, Illinois, 60612
About this study
Official title: A Pilot Study of Time-restricted Eating Among Pregnant Females With Severe Obesity
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.
Read the detailed description
Severe obesity is a contributor to adverse perinatal outcomes. The prevalence of severe obesity is on the rise in the United States (U.S.), having increased from 6.4% of the adult population in 2011-2012 to just over 9% of adults in 2017-2018. The prevalence of severe obesity among reproductive age females is approximately 10%. This is an alarming statistic given severe obesity is a predictor of adverse perinatal outcomes including gestational diabetes mellitus, preeclampsia, premature birth (both spontaneous and medically indicated), 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. Existing lifestyle interventions (calorie control/dietary pattern changes/physical activity) have showed modest effects on attenuating excess gestational weight gain and modest effects on perinatal health outcomes among pregnant females with obesity. Time- restricted eating, where an individual simply watches the clock and consumes calories within a particular eating window, is a simple and highly accessible eating pattern that has the potential to minimize gestational weight gain, reduce excess glucose and lipids, and improve metabolic health among pregnant females with severe obesity all of which could translate to improved perinatal health outcomes. Yet there are no clinical trials of time-restricted eating in pregnancy. The investigators aim to test the safety, feasibility, and acceptability of time-restricted eating among 60 pregnant females with severe obesity. The investigators will examine time-restricted eating safety, feasibility and acceptability (8-hr eating window in the 2nd trimester \& 10-hr eating window in the 3rd trimester), and explore its effects on weight, cardiometabolic risk markers and perinatal health outcomes vs. Standard Care. The intervention will begin between 14 - < = 20 weeks gestational age and continue through admission for labor and delivery. The study will involve weekly meetings with a nutritionist, and research visits at baseline (~17 weeks gestational age), 27-29 weeks gestational age and 35-37 weeks gestational age as well as monthly check-ins for maternal and fetal health monitoring. Maternal and neonatal data from labor and delivery will also be collected from electronic health records. Glucose will be continuously monitored for 10 days at 20 weeks gestational age and 34 weeks gestational age (optional). The goal of our work is to reduce and prevent adverse perinatal outcomes among pregnant females with severe obesity. Given the relative simplicity of time-restricted eating it can be easily disseminated in clinic demonstrating its strong potential for wide-scale public health impact.
- Being tested
- Time Restricted Eating
- Medical subject headings
- Obesity, Morbid, Intermittent Fasting, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted EatingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted eating | Experimental | 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. Receives: Behavioral: Time Restricted Eating |
| Enhanced Standard Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
≥ 30% of those approached enroll
Measured: From 6 months through 32 months (the funding period is 36 months)
Trial safety - Maternal Complete Blood Count
% and n with abnormal results by study arm
Measured: Baseline (14-20 weeks gestational age) and monthly through labor and delivery, about 6 months
Trial safety - Non-stress Test for Fetal Safety
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
Measured: 29-31 weeks gestational age and 35-37 weeks gestational age
Intervention acceptability
Semi-structured interviews
Measured: 25-27 weeks gestational age and 35-37 weeks gestational age
Research visit feasibility
Number of data collection visits completed with >=80% completed at each timepoint and completeness of data
Measured: Baseline, 25-27 weeks gestational age and 35-37 weeks gestational age
Intervention (TRE) session feasibility
Number and % of intervention sessions completed by TRE participants
Measured: Weekly from baseline through labor and delivery, about 6 months
TRE adherence
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
Measured: Daily from enrollment to labor and delivery (TRE arm only), about 6 months
Trial safety - Maternal health checks
Weekly maternal health checks via videoconference in TRE and control group that is verified with electronic health record
Measured: Weekly from baseline to labor and delivery, about 6 months, % and n for health events reported by study arm
Trial safety - Maternal outcomes
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
Measured: Labor and delivery
Trial safety - Neonatal outcomes
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
Measured: Labor and delivery
Trial Retention
n and % of women retained through the final in-person data collection with >= 80% retained
Measured: 35-37 week gestational age
Secondary outcomes (8)
Maternal Body Weight
Body weight in kilograms
Measured: Baseline (14-20 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age
Maternal Fasting Blood Glucose
Measured in serum
Measured: Baseline (14-20 weeks gestational age), 25-27 weeks gestational age, 35-37 weeks gestational age
Maternal Fasting Insulin
Measured in serum
Measured: Baseline (14-20 weeks gestational age), 25-27 weeks gestational age, 35-37 weeks gestational age
Maternal Fasting Blood Lipids
Cholesterol and triglycerides
Measured: Baseline (14-20 weeks gestational age), 25-27 weeks gestational age, 35-37 weeks gestational age
Maternal C-reactive protein
Measured in plasma
Measured: Baseline (14-20 weeks gestational age), 25-27 weeks gestational age, 35-37 weeks gestational age
Maternal Systolic Blood Pressure
Measured with participant in a seated position using an automated cuff
Measured: Baseline (14-20 weeks gestational age), 25-27 weeks gestational age, 35-37 weeks gestational age
Maternal Diastolic Blood Pressure
Measured with participant in a seated position using an automated cuff
Measured: Baseline (14-20 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age
Maternal Hb A1c
Measured from whole blood
Measured: Baseline (14-20 weeks gestational age), 25-27 weeks gestational age, 35-37 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start9 Sep 2024
- Primary completion16 Sep 2026
- Study completion29 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 allocation ratio. Randomization will be stratified by participant age (18-30 and 31-44 years old).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Tussing-Humphreys, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477120
- Sponsor's protocol ID
- 2024-0138
- Other IDs
- 5R01DK136085-02
- Acronym
- TRE-Preg
- Status last verified
- Oct 2026
- First submitted
- 30 May 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No