A Pilot Study of Time-restricted Eating Among Pregnant Females With Severe Obesity

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In the United States, severe obesity (body mass index (BMI) ≥ 40.0 kg/m2) affects approximately 10% of females 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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 44
Healthy Volunteers: t
View:

• Female based on sex assigned at birth

• Preconception body mass index (BMI) 35.0 - 50 kg/m2

• Singleton pregnancy

• Age 18-44 years old

• \< = to 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

Locations
United States
Illinois
University of Illinois at Chicago College of Applied Health Sciences
RECRUITING
Chicago
Contact Information
Primary
Lisa Tussing-Humphreys, PhD, RD
tussing@uic.edu
312-355-5521
Backup
Mary Dawn Koenig, PhD, RN
marydh@uic.edu
(312) 996-7942
Time Frame
Start Date: 2024-09-09
Estimated Completion Date: 2026-11-29
Participants
Target number of participants: 60
Treatments
Experimental: Time-restricted eating
Participants randomized to the time-restricted eating arm will be instructed to eat ad libitum during an 8-hr window daily 11am - 7pm in the 2nd trimester and 10-hr eating window from 10am - 8pm in the 3rd trimester and abstain from caloric foods and beverages for the remaining 14-16 hours. During the eating window there will be no restrictions on types or quantities of foods consumed. Moreover, participants will not be required to monitor calorie intake during the ad libitum eating period. During the fasting period, participants will be encouraged to drink plenty of water and will be allowed to consume calorie-free beverages.
No_intervention: Standard Care
The standard care arm will not receive diet-related counseling. Participants will meet with study staff weekly to record health changes and to transmit weight through the text messaging platform. The remote videoconferencing visits will occur at the same day and time each week. Standard care participants will attend the in-person research data collection visits. Participants will be asked to maintain current (baseline) level of physical activity throughout the intervention.
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of Illinois at Chicago

This content was sourced from clinicaltrials.gov