Time-restricted Eating Among Pregnant Females With Severe Obesity
Sponsored by University of Illinois at Chicago
About this study
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.
Severe obesity is a contributor to adverse perinatal outcomes. The prevalence of severe obesity is on the rise in the United States (U.S.), having increased from 6.4% of the adult population in 2011-2012 to just over 9% of adults in 2017-2018. The prevalence of severe obesity among reproductive age females is approximately 10%. This is an alarming statistic given severe obesity is a predictor of adverse perinatal outcomes including gestational diabetes mellitus, preeclampsia, premature birth (both spontaneous and medically indicated), 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 lip…
Where this study is enrolling
- I'm interested
University of Illinois at Chicago College of Applied Health Sciences
Chicago, Illinois
Who can participate
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
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.