PREnatal Choline and Infant Outcomes Study (PRECIOUS)

April 6, 2026 updated by: Ericka Biagioni, East Carolina University
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At 1-month postnatal: Infant body composition will be evaluated at 1-month by DXA scan.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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.
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
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.
At 16-weeks and 36-weeks gestation: Maternal body composition will be assessed by BOD POD (COSMED).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
East Carolina University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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