PREnatal Choline and Infant Outcomes Study (PRECIOUS)

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.

Study Overview

• Status: Recruiting
• Conditions: Nutrition During Pregnancy
• Intervention / Treatment: Behavioral: Choline nutrition education (CNE)

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ericka M Biagioni, PhD, RDN; Phone Number: 252-737-5043; Email: biagionie24@ecu.edu

Study Locations

• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27858
      • Recruiting
      • East Carolina University
      • Contact: Ericka M Biagioni, PhD, RDN; Phone Number: 252-737-5043; Email: biagionie24@ecu.edu
      • Contact: Linda May, MS, PhD; Phone Number: 252-737-7072; Email: mayl@ecu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Choline Nutrition Education; Participants will receive choline nutrition education (CNE) between gestational weeks 16 through 36.	Behavioral: Choline nutrition education (CNE); All choline nutrition education (CNE) will be delivered virtually once every 4 weeks at Gestational Week 18, 22, 26, 30, and 34. Participants will also receive a check-in message at Gestational Week 20, 24, 28, and 32, asking them to confirm that they have read through the CNE materials and if they have any questions.
No Intervention: Usual Care; Usual care, control group. Participants will receive the intervention materials at 36 weeks of gestation after completion of all 36-wk measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary choline consumption	Multiple 24-hour dietary recalls	At 16-weeks and 36-weeks gestation: Participants will complete the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool on 3 separate days (2 weekdays and 1 weekend day) to determine daily dietary choline intake in grams.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant body fat	DXA scan to measure body fat percentage in 1-month old infants.	At 1-month postnatal: Infant body composition will be evaluated at 1-month by DXA scan.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma choline concentration	Maternal venipuncture	At 16-weeks and 36-weeks gestation: Maternal blood will be collected and centrifuged, then a colorimetric plate-based assay (Choline Assay Kit, ab219944) will be used to quantify choline concentrations in maternal plasma samples.
Infant cellular lipid storage	At delivery: Infant mesenchymal stem cells (MSCs) will be isolated from umbilical cord tissue. Undifferentiated MSCs (D0) will be cultured in growth medium, and adipogenesis will be induced for 21 days (D21). Adipogenic differentiation will be confirmed by western blotting for protein expression of adipogenic marker PPARγ at D0 and D21. Cellular lipid accumulation will be evaluated in MSCs at D0 and D21 using Oil Red O (ORO) staining.	At delivery: Infant mesenchymal stem cells (MSCs) will be isolated from umbilical cord tissue and Oil-Red O staining will be used to measure intracellular lipid accumulation of adipogenic differentiated MSCs.
Maternal body composition	Maternal body composition will be assessed by BOD POD (COSMED) to determine fat mass.	At 16-weeks and 36-weeks gestation: Maternal body composition will be assessed by BOD POD (COSMED).

Collaborators and Investigators

• Sponsor: East Carolina University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Estimated): May 14, 2027
• Study Completion (Estimated): May 14, 2027

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 25-000906; 12296 (Other Grant/Funding Number: The Gerber Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified data can be shared upon request to researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No