Ignite Creation Date:
2024-07-17 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477120
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-05-30
Brief Title:
Time-restricted Eating Among Pregnant Females With Severe Obesity
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
A Pilot Study of Time-restricted Eating Among Pregnant Females With Severe Obesity
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRE-Preg
Brief Summary:
In the United States severe obesity body mass index BMI 400 kgm2 affects approximately 10 of females of reproductive age with Black females disproportionately burdened 16 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 - outcomes that also disproportionately affect Black females 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
Detailed Description:
Severe obesity is a contributor to adverse perinatal outcomes and Black females are disproportionately burdened The prevalence of severe obesity is on the rise in the United States US having increased from 64 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 lipids in the gestational period may be important to reducing perinatal health risks among pregnant females with severe obesity Existing lifestyle interventions calorie controldietary pattern changesphysical activity have showed modest effects on attenuating excess gestational weight gain and modest effects on perinatal health outcomes among pregnant females with obesity Time- restricted eating where an individual simply watches the clock and consumes calories within a particular eating window is a simple and highly accessible eating pattern that has the potential to minimize gestational weight gain reduce excess glucose and lipids and improve metabolic health among pregnant females with severe obesity all of which could translate to improved perinatal health outcomes Yet there are no clinical trials of time-restricted eating in pregnancy The investigators aim to test the safety feasibility and acceptability of time-restricted eating among 80 pregnant females with severe obesity The investigators will examine time-restricted eating safety feasibility and acceptability 8-hr eating window in the 2nd trimester 10-hr eating window in the 3rd trimester and explore its effects on weight cardiometabolic risk markers and perinatal health outcomes vs Standard Care The intervention will begin at 17 weeks gestational age and continue through admission for labor and delivery The study will involve weekly meetings with a nutritionist and research visits at baseline 17 weeks gestational age 27-29 weeks gestational age and 35-37 weeks gestational age as well as monthly check-ins for maternal and fetal health monitoring Maternal and neonatal data from labor and delivery will also be collected from electronic health records Glucose will be continuously monitored for 10 days at 20 weeks gestational age and 34 weeks gestational age optional The goal of our work is to reduce and prevent adverse perinatal outcomes among pregnant females with severe obesity Given the relative simplicity of time-restricted eating it can be easily disseminated in clinic demonstrating its strong potential for wide-scale public health impact
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None