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PREnatal Choline and Infant Outcomes Study

East Carolina University · NCT07525193

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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
PREnatal Choline and Infant Outcomes Study (NCT07525193) | Bored Studies