Trials / Active Not Recruiting
Active Not RecruitingNCT04274140
Maternal Obesity and Offspring Neurodevelopment
Maternal Obesity and Offspring Neurodevelopment: the MOON Study
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 260 (estimated)
- Sponsor
- Arkansas Children's Hospital Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
Timeline
- Start date
- 2019-10-03
- Primary completion
- 2026-08-30
- Completion
- 2027-10-31
- First posted
- 2020-02-18
- Last updated
- 2025-12-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04274140. Inclusion in this directory is not an endorsement.