NCT07525193 PREnatal Choline and Infant Outcomes Study
| NCT ID | NCT07525193 |
| Status | Recruiting |
| Phase | — |
| Sponsor | East Carolina University |
| Condition | Nutrition During Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2027-05-14 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 102 participants in total. It began in 2025-05-15 with a primary completion date of 2027-05-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07525193 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Nutrition During Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07525193 currently recruiting?
Yes, NCT07525193 is actively recruiting participants. Contact the research team at biagionie24@ecu.edu for enrollment information.
Where is the NCT07525193 trial being conducted?
This trial is being conducted at Greenville, United States.
Who is sponsoring the NCT07525193 clinical trial?
NCT07525193 is sponsored by East Carolina University. The trial plans to enroll 102 participants.