- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04274140
Maternal Obesity and Offspring Neurodevelopment (Moon)
July 28, 2023 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
Recruiting
Conditions
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
Observational
Enrollment (Estimated)
160
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
- Name: Ashton Adkison, BS
- Phone Number: 5013643309
- Email: acncstudies@archildrens.org
Study Contact Backup
- Name: Matthew Keene, BA
- Phone Number: 5013643309
- Email: acncstudies@archildrens.org
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72202
- Recruiting
- Arkansas Children's Nutrition Center
-
Contact:
- Ashton Adkison, BS
- Phone Number: 5013643309
- Email: acncstudies@archildrens.org
-
Contact:
- Matthew Keene, BA
- Phone Number: 501-364-3309
- Email: acncstudies@archildrens.org
-
-
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
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 160 pregnant women (N=75 for normal weight, BMI 18.5-25, and N=85 for obese, BMI 30-50) at <12 weeks of pregnancy.
The goal is to obtain neuroimaging data from 120 infants (N=60/60 from normal-weight or obese mothers) at age ~2 weeks, and to follow up all children at age 1 and 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 |
---|
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
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.
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)
October 3, 2019
Primary Completion (Estimated)
April 30, 2024
Study Completion (Estimated)
October 31, 2024
Study Registration Dates
First Submitted
November 13, 2019
First Submitted That Met QC Criteria
February 14, 2020
First Posted (Actual)
February 18, 2020
Study Record Updates
Last Update Posted (Actual)
August 1, 2023
Last Update Submitted That Met QC Criteria
July 28, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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