RECRUITING

Time-restricted Eating Among Pregnant Females With Severe Obesity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In the United States, severe obesity (body mass index (BMI) ≥ 40.0 kg/m2) 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.

Official Title

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

Quick Facts

Study Start:2024-09-09
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06477120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 44 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female based on sex assigned at birth
  2. * Preconception body mass index (BMI) 40.0 - 50 kg/m2
  3. * Singleton pregnancy
  4. * Age 18-44 years old
  5. * \< = to 17 weeks gestational age
  6. * Fluency in English to provide consent and complete study procedures
  7. * Ability to provide informed consent
  8. * Cleared by study doctor and the obstetrician/mid-wife provider to participate
  9. * Access to a smartphone to complete intervention procedures
  1. * Deemed medically high risk
  2. * Multiple pregnancy (e.g., twins)
  3. * Type 1 or 2 diabetes mellitus
  4. * Early gestational diabetes (diagnosed at \< = to17 weeks gestational age through an oral glucose tolerance test)
  5. * Currently eating ≤ 12 hours daily
  6. * Autoimmune disorder (e.g., rheumatoid arthritis)
  7. * iron deficiency anemia
  8. * Inflammatory bowel disease
  9. * Previous spontaneous preterm birth
  10. * History of bariatric surgery
  11. * Night shift work
  12. * Currently incarcerated

Contacts and Locations

Study Contact

Lisa Tussing-Humphreys, PhD, RD
CONTACT
312-355-5521
tussing@uic.edu
Mary Dawn Koenig, PhD, RN
CONTACT
(312) 996-7942
marydh@uic.edu

Study Locations (Sites)

University of Illinois at Chicago College of Applied Health Sciences
Chicago, Illinois, 60612
United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-09
Study Completion Date2027-02

Study Record Updates

Study Start Date2024-09-09
Study Completion Date2027-02

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity, Morbid
  • Time Restricted Eating
  • Pregnancy Weight Gain