HealthyMoonNCT04274140
Maternal Obesity and Offspring Neurodevelopment
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2019to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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. .
Who may be able to join
- Singleton pregnancy
- 11-13 weeks of gestation -≥18 years of age.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
Official title: 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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese Pregnant Women | obese, BMI 30-50 | |
| Normal weight pregnant women | normal weight, BMI 18.5-25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: MRIs will be performed on babies at 2 weeks, 1 year, and 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start3 Oct 2019
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274140
- Sponsor's protocol ID
- 239304
- Acronym
- Moon
- Status last verified
- Dec 2025
- First submitted
- 13 Nov 2019
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Obesity and Offspring Neurodevelopment: the MOON Study
- ClinicalTrials.gov ID
- NCT04274140
- Acronym / sponsor ID
- Moon / 239304
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese Pregnant Women | – | –obese, BMI 30-50 |
| Normal weight pregnant women | – | –normal weight, BMI 18.5-25 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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. .
Key inclusion criteria (2 listed)
- Singleton pregnancy
- 11-13 weeks of gestation -≥18 years of age.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.