Time-restricted Eating Among Pregnant Females With Severe Obesity
Recruiting · NCT06477120 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Illinois at Chicago
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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
Where it is running
1 location listed across 1 US state.
- University of Illinois at Chicago College of Applied Health Sciences - Chicago, Illinois, United States