Maternal Obesity and Offspring Neurodevelopment

NCT ID: NCT04274140

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-03
• Study Completion Date: 2027-10-31

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.

Detailed Description

About one third of all women of reproductive age in the US are obese (body mass index [BMI] ≥ 30). Recent studies show that children born to mothers who were obese while pregnant may have lower cognitive performance and higher risk of developing neurodevelopmental conditions. The goal of this study is to see 1) if there are negative effects of maternal obesity during pregnancy on newborn's brain development; 2) if these effects on brain development persist to age 1 & 2 years, and if there are changes in neurodevelopmental outcomes associated with maternal obesity; and 3) if inflammation in pregnant women associated with maternal obesity is one of the main reasons for the brain changes in offspring. The investigators will recruit pregnant women from early pregnancy who are either obese or normal weight and are otherwise healthy. The Investigators will measure their weight, body fat percentage, blood inflammation markers, family environment, what the participants normally eat, how much physical activity the participants usually have, and other characteristics during pregnancy. When their babies are born, the investigators will evaluate the brain development of their babies use magnetic resonance imaging (during natural sleep) at age two weeks and again at age 1&2 years. The investigators will also measure the neurodevelopmental outcomes at age 2 years. Then compare the findings to see if there are group differences in these measures between babies born to normal-weight and obese mothers, if other parameters measured at pregnancy also play a role, and if inflammation markers during pregnancy strongly correlate with infant brain development and neurodevelopmental outcomes.

Conditions

Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Obese Pregnant Women

obese, BMI 30-50

No interventions assigned to this group

Normal weight pregnant women

normal weight, BMI 18.5-25

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Singleton pregnancy
• 11-13 weeks of gestation -≥18 years of age.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Arkansas Children's Nutrition Center

Little Rock, Arkansas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

239304

Identifier Type: -

Identifier Source: org_study_id