Time-restricted Eating Among Pregnant Females With Severe Obesity

Study acronym: TRE-Preg
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Enrollment closed, study ongoing Show 4 more changesShow less
    • Primary completion date changed from estimate of Aug 31, 2026 to Sep 16, 2026
    • Eligibility criteria expanded, about 22 words
    • Study description revised
    • Site details revised
  2. Primary endpoints: 10 to 11
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 2 words
    v6
  3. Primary endpoints: 6 to 10
    • Secondary endpoints: 7 to 8
    • Eligibility criteria shortened, about 1 word
    • Study description expanded, about 2 words
    v5
  4. Enrollment target: 80 to 60v4 Show 5 more changesShow less
    • Primary completion date: Dec 2026 to Aug 31, 2026
    • Study completion date: Feb 2027 to Nov 29, 2026
    • Study description shortened, about 6 words
    • Collaborators expanded, about 10 words
    • Eligibility criteria expanded, about 2 words
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2024 to Sep 9, 2024
    • Site details revised
    v3
  6. Eligibility criteria expanded, about 3 wordsv2
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In the United States, a body mass index (BMI) of at least 35.0 kg/m2 affects about 15% of women 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.
Trial Details
NCT Number NCT06477120
Lead Sponsor University of Illinois at Chicago
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Obesity, Morbid, Time Restricted Eating, Pregnancy Weight Gain
Related terms Gestational Weight Gain, Intermittent Fasting, Obesity, Morbid
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov