Actively Recruiting
PREnatal Choline and Infant Outcomes Study Evaluating Choline Nutrition Education and Its Effects on Maternal and Infant Health
Led by East Carolina University · Updated on 2026-04-13
102
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of prenatal choline nutrition education on maternal choline intake, placental efficiency, and infant health. The study focuses on pregnant women aged 18 to 40 with a healthy singleton pregnancy. Choline is an essential nutrient important for maternal lipid metabolism, placental function, and fetal development, yet less than 10% of pregnant women consume enough, and few prenatal vitamins contain it. This study aims to understand how education based on the Health Belief Model can improve these outcomes. Participants are randomly assigned to either receive choline nutrition education or usual care. Those in the education group will receive virtual lessons every four weeks from gestational weeks 18 to 34, with additional check-in messages between lessons to encourage engagement. The control group will receive usual care and access to the educational materials only after completing all study assessments at 36 weeks gestation. Throughout the study, participants complete dietary assessments at 16 and 36 weeks gestation to measure choline intake. Infant body composition will be evaluated using a DXA scan at one month postnatal. Researchers will monitor maternal diet, placental efficiency, and infant body fat to assess the impact of the education. Participation lasts from early pregnancy through one month after birth, with ongoing data collection to understand maternal and child health outcomes.
CONDITIONS
Brief Title
PREnatal Choline and Infant Outcomes Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy pregnant individual
- Singleton pregnancy
- 18 to 40 years of age
- Pre-pregnancy body mass index (BMI) of 18.5 or higher
You will not qualify if you...
- Any non-pregnancy-related illness or chronic condition that may affect fetal development (such as HIV, cancer, heart disease, or pre-existing diabetes)
- Known fetal anomaly
- Allergy to choline-rich foods such as eggs
- Multiple pregnancies
- Older than 40 years of age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - Approximately 20 weeks during pregnancy
Participants receive choline nutrition education virtually every 4 weeks between gestational weeks 16 and 36, with additional check-in messages between education sessions.
5 virtual education visits and 4 check-in messages
Duration - 1 month postnatal
Infant body composition is evaluated at 1 month postnatal to assess infant body fat.
1 visit (in-person) for DXA scan
Trial Site Locations
Total: 1 location
1
East Carolina University
Greenville, North Carolina, United States, 27858
Actively Recruiting
Research Team
E
Ericka M Biagioni, PhD, RDN
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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