NOT_YET_RECRUITING
Time-restricted Eating Among Pregnant Females With Severe Obesity
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.
Conditions:
🦠 Obesity, Morbid 🦠 Time Restricted Eating 🦠 Pregnancy Weight Gain
🗓️ Study Start (Actual) August 2024
🗓️ Primary Completion (Estimated) December 2026
✅ Study Completion (Estimated) February 2027
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Female based on sex assigned at birth
    • * Preconception body mass index (BMI) 40.0 - 50 kg/m2
    • * Singleton pregnancy
    • * Age 18-44 years old
    • * \< = to 17 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

    Exclusion Criteria:

    • * 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)
    • * Currently eating ≤ 12 hours daily
    • * Autoimmune disorder (e.g., rheumatoid arthritis)
    • * iron deficiency anemia
    • * Inflammatory bowel disease
    • * Previous spontaneous preterm birth
    • * History of bariatric surgery
    • * Night shift work
    • * Currently incarcerated
Ages Eligible for Study: 18 Years to 44 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ 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

  • First Submitted 30 May 2024
  • First Submitted that Met QC Criteria 23 June 2024
  • First Posted 27 June 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 June 2024
  • Last Update Posted 28 June 2024
  • Last Verified June 2024