PREnatal Choline and Infant Outcomes Study
East Carolina University · NCT07525193
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–40 · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 102
- US sites recruiting
- 1
- Study start
- May 15, 2025
- Record last updated
- April 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Choline nutrition education (CNE)
Conditions: Nutrition During Pregnancy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
East Carolina University
Greenville, NC 27858
Site contact: Ericka M Biagioni, PhD, RDN · 252-737-5043 · biagionie24@ecu.edu
Study contacts (from the official record)
- Ericka M Biagioni, PhD, RDN · 252-737-5043 · biagionie24@ecu.edu
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