Time-restricted Eating Among Pregnant Females With Severe Obesity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorUniversity of Illinois at Chicago

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

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Illinois at Chicago

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator