About this trial
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
Qualifiers
Female based on sex assigned at birth
Preconception body mass index (BMI) 35.0 - 60 kg/m2
Singleton pregnancy
Age 18-44 years old
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Time Restricted Eating
Treatment groups
Sponsors and collaborators
University of Illinois at Chicago
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator