Wednesday, February 5, 2025
2/5/2025
ABSTRACT In the United States, severe obesity (BMI ≥ 40.0 kg/m2) disproportionally affects non-Hispanic Black females of reproductive age. Severe obesity is a significant predictor of adverse perinatal outcomes including gestational diabetes mellitus (GDM), 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. Existing lifestyle interventions (calorie control/dietary pattern changes/physical 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 (TRE), 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 TRE in pregnancy. In response to PAS-20-160 - Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK, we aim to test the safety, feasibility, and acceptability of TRE among 60 pregnant Black females with severe obesity. We will examine the preliminary efficacy of TRE (8-hr eating window in the 2nd trimester & 10-hr eating window in the 3rd trimester) vs. Standard Care on safety, feasibility, and preliminary efficacy on weight, cardiometabolic risk markers and perinatal health outcomes. The intervention will begin at ~16 weeks gestational age (GA) and continue through admission for labor and delivery. The study will involve weekly meetings with a research team member, and research visits at baseline (~16 weeks GA), 25-27 weeks GA and 35-37 weeks GA. Maternal and fetal health monitoring will occur weekly through a combination of research specific assessments and clinical data collected during routine prenatal care and at labor and delivery via patient electronic health records. The goal of our work is to reduce and prevent adverse perinatal outcomes among pregnant Black females including those with severe obesity. In alignment with NIDDK’s mission, this small-scale R01 study will provide the necessary data to accelerate the initiation of a full-scale efficacy trial of TRE in pregnancy. Given the relative simplicity of TRE it can be easily disseminated in clinic demonstrating its strong potential for wide-scale public health impact.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).