Maternal Obesity and Offspring Neurodevelopment (Moon)

December 8, 2025 updated by: Arkansas Children's Hospital Research Institute

Maternal Obesity and Offspring Neurodevelopment: the MOON Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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. .

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Obese Pregnant Women
obese, BMI 30-50
Normal weight pregnant women
normal weight, BMI 18.5-25

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To detect changes in brain development by magnetic resonance imaging (MRI)
Time Frame: MRIs will be performed on babies at 2 weeks, 1 year, and 2 years.
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.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 239304

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings