Nutrition During PregnancyPRECIOUSNCT07525193
PREnatal Choline and Infant Outcomes Study
A study testing Choline nutrition education (CNE) in people with Nutrition During Pregnancy, run by East Carolina University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition During Pregnancy
- What is being tested?
- Choline nutrition education (CNE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2025to 14 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnant individual
- Singleton pregnancy
- 18-40 years of age
- Pre-pregnancy BMI ≥ 18.5
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
East Carolina University
Greenville, North Carolina, 27858
Ericka M Biagioni, PhD, RDN, 252-737-5043, biagionie24@ecu.edu
Linda May, MS, PhD, 252-737-7072, mayl@ecu.edu
About this 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.
- Conditions
- Nutrition During Pregnancy
- Being tested
- Choline nutrition education (CNE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choline nutrition education (CNE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Choline Nutrition Education | Experimental | Participants will receive choline nutrition education (CNE) between gestational weeks 16 through 36. Receives: Behavioral: Choline nutrition education (CNE) |
| Usual Care | No intervention | Usual care, control group. Participants will receive the intervention materials at 36 weeks of gestation after completion of all 36-wk measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary choline consumption
Multiple 24-hour dietary recalls
Measured: 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.
Measured: At 1-month postnatal: Infant body composition will be evaluated at 1-month by DXA scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start15 May 2025
- Primary completion14 May 2027 (estimated)
- Study completion14 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition During PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ericka Biagioni, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525193
- Sponsor's protocol ID
- 25-000906
- Other IDs
- 12296
- Acronym
- PRECIOUS
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data can be shared upon request to researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREnatal Choline and Infant Outcomes Study
- ClinicalTrials.gov ID
- NCT07525193
- Acronym / sponsor ID
- PRECIOUS / 25-000906
- Conditions
- Nutrition During Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 14 May 2027 (estimated)
- Study completion
- 14 May 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Choline Nutrition Education | Experimental | Behavioral: Choline nutrition education (CNE)Participants will receive choline nutrition education (CNE) between gestational weeks 16 through 36. |
| Usual Care | No intervention | –Usual care, control group. Participants will receive the intervention materials at 36 weeks of gestation after completion of all 36-wk measures. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy pregnant individual
- Singleton pregnancy
- 18-40 years of age
- Pre-pregnancy BMI ≥ 18.5
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Choline Nutrition Education |
Primary outcome
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
1 secondary outcome
Infant body fat
Time frame: At 1-month postnatal: Infant body composition will be evaluated at 1-month by DXA scan.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided. De-identified data can be shared upon request to researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choline nutrition education (CNE) in people with Nutrition During Pregnancy, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ericka M Biagioni, PhD, RDN (252-737-5043, biagionie24@ecu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.