NCT03499587

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Mar 2018Dec 2026

Study Start

First participant enrolled

March 21, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2026

Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

8.3 years

First QC Date

April 9, 2018

Last Update Submit

October 15, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Determine whether maternal obesity correlates with abnormal brain development in newborns

    Brain will be imaged at 2wks using an MRI

    2 weeks

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant healthy volunteers

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2018

First Posted

April 17, 2018

Study Start

March 21, 2018

Primary Completion (Estimated)

June 27, 2026

Study Completion (Estimated)

December 27, 2026

Last Updated

October 20, 2025

Record last verified: 2025-10

Locations

US(1)