Choline education during pregnancy to help placentas and newborns
Official title: PREnatal Choline and Infant Outcomes Study
Run by East Carolina University · NCT07525193 · Data updated 2026-11-12
This trial will test whether giving pregnant people choline nutrition education increases their choline levels and improves placental function and newborn body composition.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 102 (estimated) |
| Sponsor | East Carolina University Academic / other |
| Locations | 1 site (Greenville, North Carolina) |
| Status | Recruiting |
| Started | May 15, 2025 |
| Main results expected | May 14, 2027 |
| Study ends | May 14, 2027 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07525193 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy pregnant individuals aged 18–40 with a singleton pregnancy and pre-pregnancy BMI of at least 18.5 are the intended participants.
✕Probably not a fit
People with chronic medical conditions that affect fetal development, known fetal anomalies, egg allergy, multifetal pregnancies, or those older than 40 may not receive benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Pregnant participants receive a choline nutrition education program based on the Health Belief Model designed to increase intake of choline-rich foods and awareness of choline's role in pregnancy. Eligible participants are healthy individuals aged 18–40 with a singleton pregnancy and pre-pregnancy BMI ≥ 18.5, while those with chronic illnesses affecting fetal development, known fetal anomalies, egg allergy, or multifetal pregnancies are excluded. The study will measure changes in maternal choline levels and body fat percentage, placental efficiency, mesenchymal stem cell lipid accumulation, and infant body fat at one month. The work builds on preliminary correlations between higher choline intake and improved maternal and neonatal measures and tests whether education alone can produce meaningful biological changes.
Why it matters
Potential benefit: If successful, this approach could raise maternal choline levels and lead to healthier placental function and lower newborn body fat.
How similar studies have gone: Health Belief Model–based nutrition education has been effective in pregnancy and preliminary data link higher choline intake to better maternal and infant measures, but no prior trials have tested a prenatal choline education intervention's effects on placental and neonatal outcomes.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
East Carolina University
Greenville, North Carolina, United States Recruiting
Study contacts
- Study coordinator: Ericka M Biagioni, PhD, RDN
- Email: biagionie24@ecu.edu
- Phone: 252-737-5043
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.