Choline education during pregnancy to help placentas and newborns
PREnatal Choline and Infant Outcomes Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | East Carolina University Academic / other |
| Locations | 1 site (Greenville, North Carolina) |
| Trial ID | NCT07525193 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Greenville, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.