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Effects of Maternal Obesity on Offspring Brain Development

Sponsor
Arkansas Children's Hospital Research Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03499587
Collaborator
(none)
13
Enrollment
1
Location
72.2
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to see if there are negative effects of maternal obesity during pregnancy on offspring's brain development.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study will recruit pregnant women who are either obese or normal weight and otherwise healthy. We will measure their body composition, food intake and other characteristics during pregnancy. When their babies are born, we will evaluate the brain development of their babies using magnetic resonance imaging and electroencephalography at age two weeks. We will then compare the findings and see if their are differences.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    13 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effects of Maternal Obesity on Offspring Brain Development
    Actual Study Start Date :
    Mar 21, 2018
    Anticipated Primary Completion Date :
    Mar 27, 2024
    Anticipated Study Completion Date :
    Mar 27, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Obese pregnant women

    BMI >30 with early OB visit medical records accessible
    Normal weight pregnant women

    BMI 18.5-25 with early OB visit medical records accessible.

    Outcome Measures

    Primary Outcome Measures

    1. Determine whether maternal obesity correlates with abnormal brain development in newborns [2 weeks]

      Brain will be imaged at 2wks using an MRI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • BMI 18.5-25 or >30 with early OB visit medical records accessible

    • singleton pregnancy

    • about 36wks of pregnancy

    • at least 18 years of age

    Exclusion Criteria:

    • hypertension, diabetes, or other preexisting medical conditions

    • medications known to influence fetal growth

    • recreational drugs, nicotine or tobacco use of alcohol use while pregnant

    • pregnancy conception with assisted fertility treatment

    • medical complications developed during pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arkansas Children's Nutrition Center Little Rock Arkansas United States 72202

    Sponsors and Collaborators

    • Arkansas Children's Hospital Research Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arkansas Children's Hospital Research Institute
    ClinicalTrials.gov Identifier:
    NCT03499587
    Other Study ID Numbers:
    • 206551
    First Posted:
    Apr 17, 2018
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Obesity, Maternal

    Study Results

    No Results Posted as of Aug 5, 2022