Effects of Maternal Obesity on Offspring Brain Development

December 18, 2023 updated by: Arkansas Children's Hospital Research Institute
The goal of this study is to see if there are negative effects of maternal obesity during pregnancy on offspring's brain development.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Nutrition Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant healthy volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine whether maternal obesity correlates with abnormal brain development in newborns
Time Frame: 2 weeks
Brain will be imaged at 2wks using an MRI
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

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 Major Dates

Study Start (Actual)

March 21, 2018

Primary Completion (Estimated)

March 27, 2024

Study Completion (Estimated)

March 27, 2024

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206551

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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