Maternal Obesity and Offspring Neurodevelopment

NCT04274140 | Active Not Recruiting DMC

• 1 other identifier: 239304
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• To detect changes in brain development by magnetic resonance imaging (MRI)

  The primary aim is to compare brain development in babies born to lean and obese.mothers by performing MRI scans on babies at 2 weeks, 1 year, and 2 years of life. Mother's BMI will be determined during the clinical visits.

  MRIs will be performed on babies at 2 weeks, 1 year, and 2 years.

Study Arms (2)

Obese Pregnant Women

obese, BMI 30-50

Normal weight pregnant women

normal weight, BMI 18.5-25

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit 260 pregnant women (N=130 for normal weight, BMI 18.5-25, and N=130 for obese, BMI 30-50) at \<12 weeks of pregnancy. This is an increase of sample size from the previous number of 120 normal weight women and 120 obese women. The reason is that due to a pandemic, a series factors (such as suspension of all clinical research visits; participants skipping research visits because of COVID concerns) have resulted in that we were not able to get complete data from some of the enrolled subjects at some time points. Our goal is still to obtain complete neuroimaging and maternal clinical data from 120children (N=60/60 from normal-weight or obese mothers) at age \~2 years. .

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

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: November 13, 2019
• First Posted: February 18, 2020
• Study Start: October 3, 2019
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)