NCT06477120Active, not recruiting
Time-restricted Eating Among Pregnant Females With Severe Obesity
A Pilot Study of Time-restricted Eating Among Pregnant Females With Severe Obesity
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 30 May 2024
- Start date
- 9 Sept 2024
- Primary completion date
- 16 Sept 2026
- Lead sponsor
- University of Illinois Chicago
- Diseases
- Obesity
- NCT number
- NCT06477120
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 9 Sept 2024 to the primary completion date, 16 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous spontaneous preterm birth
Other illness
- Type 1 or 2 diabetes mellitus
- Autoimmune disorder (e.g., rheumatoid arthritis)
- Inflammatory bowel disease
- History of bariatric surgery
- Eating disorder
Lab values
- Early gestational diabetes (diagnosed at \< = to17 weeks gestational age through an oral glucose tolerance test)
Other
- Deemed medically high risk
- Multiple pregnancy (e.g., twins)
- Currently eating ≤ 12 hours daily
- iron deficiency anemia
- Night shift work
- Currently incarcerated
Who the study is looking for
- 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
Age in the registry: 18 years to 44 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois at Chicago College of Applied Health Sciences Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.