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Active, not recruitingNCT03499587Updated Oct 20, 2025

Effects of Maternal Obesity on Offspring Brain Development

An observational study in Healthy, sponsored by Arkansas Children's Hospital Research Institute. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-20.

Sponsored by Arkansas Children's Hospital Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
13
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Healthy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pregnant healthy volunteers

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
13 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. Determine whether maternal obesity correlates with abnormal brain development in newborns

    Brain will be imaged at 2wks using an MRI

    Time frame: 2 weeks

06

Study locations

1 site
  • Arkansas Children's Nutrition Center
    Little Rock, Arkansas 72202, United States
07

Registry details

Key details

Study ID
NCT03499587
Lead sponsor
Arkansas Children's Hospital Research Institute
Responsible party
Sponsor
First posted
Apr 17, 2018
Start date
Mar 21, 2018
Primary completion
Jun 27, 2026 (estimated)
Completion
Dec 27, 2026 (estimated)
Last update
Oct 20, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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