PREnatal Choline and Infant Outcomes Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorEast Carolina University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Healthy pregnant individual

Singleton pregnancy

18-40 years of age

Pre-pregnancy BMI ≥ 18.5

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Choline Nutrition EducationExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Dietary choline consumption

Multiple 24-hour dietary recalls

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.

Secondary outcomes

1

Infant body fat

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

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

Other outcomes

1

Plasma choline concentration

Maternal venipuncture

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.
2

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.

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.
3

Maternal body composition

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.