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PREnatal Choline and Infant Outcomes Study
Who can join
Ages 18 to 40 · Women · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Healthy pregnant individual * Singleton pregnancy * 18-40 years of age * Pre-pregnancy BMI ≥ 18.5 Exclusion Criteria: * 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
About the study
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.
What is being tested
- Choline nutrition education (CNE) (behavioral)
Sponsor: East Carolina University · Participants: 102 · Started: May 15, 2025
Contact the study team
- Ericka M Biagioni, PhD, RDN · Phone: 252-737-5043
Official record on ClinicalTrials.gov — NCT07525193
Locations in the U.S.
| North Carolina | East Carolina University, Greenville |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.