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Maternal Obesity and Offspring Neurodevelopment
Our goals are to characterize the effects of maternal obesity during pregnancy on infant brain development, reveal the neurodevelopmental consequences, and identify possible mechanisms causing these effects. Our overall hypothesis is that maternal obesity during pregnancy exposes the fetus to an inflammatory environment that affects infant brain structural and functional development and consequently neurodevelopmental outcomes. To test this hypothesis, the investigators will recruit normal-weight and obese pregnant women, examine inflammatory markers associated with obese pregnancy, and correlate them with offspring's brain development evaluated using quantitative MRI methods and outcomes evaluated using neurodevelopmental tests.
Conditions:
🦠 Healthy
🗓️ Study Start (Actual) 3 October 2019
🗓️ Primary Completion (Estimated) 30 April 2024
✅ Study Completion (Estimated) 31 October 2024
👥 Enrollment (Estimated) 160
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Little Rock, Arkansas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Singleton pregnancy
    • * 11-13 weeks of gestation -≥18 years of age.

    Exclusion Criteria:

    • * BMI measured at first study visit \<18.5 or between 26-29 or \>50
    • * hypertension, diabetes, or other preexisting medical conditions known or suspect (by the research team) to influence fetal growth;
    • * family history of psychological or neurogenetic disorders as determined by the research team that may increase the risk of adverse neurodevelopmental outcomes in offspring
    • * medications known to influence fetal growth
    • * recreational drugs, nicotine or tobacco (including smokeless) use or alcohol use while pregnant
    • * medical conditions developed during pregnancy (e.g. gestational diabetes, preeclampsia) known or suspected by the research team to influence fetal growth
    • * infants born preterm (\<37 weeks of gestation), with congenital defects, intrauterine growth restriction, small for gestational age, macrosomia, hypoglycemia, low Apgar score (\<7), or any other medical complications at birth suspected affecting development
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
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 13 November 2019
  • First Submitted that Met QC Criteria 14 February 2020
  • First Posted 18 February 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 July 2023
  • Last Update Posted 1 August 2023
  • Last Verified July 2023
I'm interested ...!!