Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
NCT07525193

PREnatal Choline and Infant Outcomes Study

Led by East Carolina University · Updated on 2026-04-13

102

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

PREnatal Choline and Infant Outcomes Study

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy pregnant individual
  • Singleton pregnancy
  • 18-40 years of age
  • Pre-pregnancy BMI 218.5
Not Eligible

You will not qualify if you...

  • 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
  • Over 40 years of age

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

East Carolina University

Greenville, North Carolina, United States, 27858

Actively Recruiting

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Research Team

E

Ericka M Biagioni, PhD, RDN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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PREnatal Choline and Infant Outcomes Study | DecenTrialz