PREnatal Choline and Infant Outcomes Study
PRECIOUS
2 other identifiers
interventional
102
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2025
CompletedFirst Submitted
Initial submission to the registry
March 23, 2026
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 14, 2027
April 13, 2026
March 1, 2026
2 years
March 23, 2026
April 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Infant body fat
At 1-month postnatal: Infant body composition will be evaluated at 1-month by DXA scan.
Other Outcomes (3)
Plasma choline concentration
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 and Oil-Red O staining will be used to measure intracellular lipid accumulation of adipogenic differentiated MSCs.
Maternal body composition
At 16-weeks and 36-weeks gestation: Maternal body composition will be assessed by BOD POD (COSMED).
Study Arms (2)
Choline Nutrition Education
EXPERIMENTALParticipants will receive choline nutrition education (CNE) between gestational weeks 16 through 36.
Usual Care
NO INTERVENTIONUsual care, control group. Participants will receive the intervention materials at 36 weeks of gestation after completion of all 36-wk measures.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Healthy pregnant individual
- Singleton pregnancy
- years of age
- Pre-pregnancy BMI ≥ 18.5
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
East Carolina University
Greenville, North Carolina, 27858, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 23, 2026
First Posted
April 13, 2026
Study Start
May 15, 2025
Primary Completion (Estimated)
May 14, 2027
Study Completion (Estimated)
May 14, 2027
Last Updated
April 13, 2026
Record last verified: 2026-03