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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Time Restricted Eating
BehavioralThe time-restricted eating arm will be instructed to eat ad libitum during an 8-hr window daily (10am - 6pm OR 11am - 7pm) in the 2nd trimester and 10-hr eating window from (9am - 7pm OR 10am - 8pm) in the 3rd trimester and abstain from caloric foods and beverages for the remaining 14-16 hours.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Time-restricted eatingExperimental treatment 1 intervention
Group B: Enhanced Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recruitment Feasibility
≥ 30% of those approached enroll
Time frame
From 6 months through 32 months (the funding period is 36 months)2
Trial safety - Maternal Complete Blood Count
% and n with abnormal results by study arm
Time frame
Baseline (14-20 weeks gestational age) and monthly through labor and delivery, about 6 months3
Trial safety - Non-stress Test for Fetal Safety
Measured with a fetal monitor to examine baby's heart rate over time (usually 20 to 30 minutes, but sometimes up to an hour) % and n with abnormal results by study arm
Time frame
29-31 weeks gestational age and 35-37 weeks gestational age4
Intervention acceptability
Semi-structured interviews
Time frame
25-27 weeks gestational age and 35-37 weeks gestational ageSecondary outcomes
1
Maternal Body Weight
Body weight in kilograms
Time frame
Baseline (14-20 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age2
Maternal Fasting Blood Glucose
Measured in serum
Time frame
Baseline (14-20 weeks gestational age), 25-27 weeks gestational age, 35-37 weeks gestational age3
Maternal Fasting Insulin
Measured in serum
Time frame
Baseline (14-20 weeks gestational age), 25-27 weeks gestational age, 35-37 weeks gestational age4
Maternal Fasting Blood Lipids
Cholesterol and triglycerides
Time frame
Baseline (14-20 weeks gestational age), 25-27 weeks gestational age, 35-37 weeks gestational ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov