NCT06477120 Time-restricted Eating Among Pregnant Females With Severe Obesity
| NCT ID | NCT06477120 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Illinois at Chicago |
| Condition | Obesity, Morbid |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-09-09 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-09-09 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06477120 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 44 Years, studying Obesity, Morbid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06477120 currently recruiting?
Yes, NCT06477120 is actively recruiting participants. Contact the research team at tussing@uic.edu for enrollment information.
Where is the NCT06477120 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06477120 clinical trial?
NCT06477120 is sponsored by University of Illinois at Chicago. The trial plans to enroll 60 participants.
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