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NCT Number: NCT07525193

PREnatal Choline and Infant Outcomes Study

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Choline nutrition education (CNE)

Behavioral

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.

Primary outcomes

  1. Dietary choline consumption

    Time frame: 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.

    Multiple 24-hour dietary recalls

Secondary outcomes

  1. Infant body fat

    Time frame: At 1-month postnatal: Infant body composition will be evaluated at 1-month by DXA scan.

    DXA scan to measure body fat percentage in 1-month old infants.

Other outcomes

  1. Plasma choline concentration

    Time frame: 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.

    Maternal venipuncture

  2. Infant cellular lipid storage

    Time frame: 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.

    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.

  3. Maternal body composition

    Time frame: At 16-weeks and 36-weeks gestation: Maternal body composition will be assessed by BOD POD (COSMED).

    Maternal body composition will be assessed by BOD POD (COSMED) to determine fat mass.

Study contacts

Contact information is provided by the study sponsor or research team.

Ericka M Biagioni, PhD, RDN

CONTACT

[email protected]

252-737-5043

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Registry information

Acronym: PRECIOUS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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