Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202, United States
NCT Number: NCT04274140
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Little Rock, Arkansas, 72202, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Arkansas Children's Hospital Research Institute
Other
Maternal Obesity and Offspring Neurodevelopment: the MOON Study
Acronym: Moon
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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