About this trial
Less than 10% of pregnant women consume adequate levels of choline, an essential nutrient for maternal lipid metabolism, placental efficiency, and fetal development. Most prenatal vitamins do not contain choline; a research survey shows that only 6% of OB/GYNs were likely to recommend choline-rich foods to pregnant women. Nutrition education grounded in the Health Belief Model (HBM) has high efficacy among pregnant women; therefore, it is likely that HBM-driven choline education intervention will increase maternal choline levels. No studies have evaluated the influence of prenatal choline education intervention on maternal, placental, and neonatal outcomes. Our preliminary data suggest that increased choline intake corresponds with lower maternal body fat percentage (BF%), infant 1-month BF%, and MSC lipid accumulation, as well as increased placental efficiency. The central hypothesis is that choline education will increase maternal choline levels and improve placental function and infant health. We will test this hypothesis with three aims: to determine the influence of choline education intervention on maternal choline intake, placental efficiency, and infant health at the whole-body and cellular levels. The proposed study will be the first to provide a critical translational understanding of the influence of prenatal choline education intervention on maternal, placental, and child health.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy pregnant individual
Singleton pregnancy
18-40 years of age
Pre-pregnancy BMI ≥ 18.5
Disqualifiers
Any non-pregnancy-related illness or chronic condition that may impact fetal development (i.e., HIV, cancer, heart disease, pre-existing diabetes) or known fetal anomaly
Food allergy to choline-rich foods (i.e., eggs)
Multi fetal pregnancy
>40 years of age
Trial design
Parallel
Treatments tested in this trial
Choline nutrition education (CNE)
BehavioralAll choline nutrition education (CNE) will be delivered virtually once every 4 weeks at Gestational Week 18, 22, 26, 30, and 34. Participants will also receive a check-in message at Gestational Week 20, 24, 28, and 32, asking them to confirm that they have read through the CNE materials and if they have any questions.
Treatment groups
Trial outcomes
Primary outcomes
Dietary choline consumption
Multiple 24-hour dietary recalls
Secondary outcomes
Infant body fat
DXA scan to measure body fat percentage in 1-month old infants.
Other outcomes
Plasma choline concentration
Maternal venipuncture
Infant cellular lipid storage
At delivery: Infant mesenchymal stem cells (MSCs) will be isolated from umbilical cord tissue. Undifferentiated MSCs (D0) will be cultured in growth medium, and adipogenesis will be induced for 21 days (D21). Adipogenic differentiation will be confirmed by western blotting for protein expression of adipogenic marker PPARγ at D0 and D21. Cellular lipid accumulation will be evaluated in MSCs at D0 and D21 using Oil Red O (ORO) staining.
Maternal body composition
Maternal body composition will be assessed by BOD POD (COSMED) to determine fat mass.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.