Recruiting

Choline Education

Sponsor:

East Carolina University

Code:

NCT07525193

Conditions

Nutrition During Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Choline nutrition education (CNE)

Study Details

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.

Conditions

Nutrition During Pregnancy

Study ID

NCT07525193

Start date

May 15, 2025

Status verified date

Mar, 2026

Completion date

May 14, 2027

Anticipated

Primary completion date

May 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

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 Design

Enrollment

102 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Choline Nutrition Education

Participants will receive choline nutrition education (CNE) between gestational weeks 16 through 36.

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.

Interventions

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.

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. ]

Central Contacts and Locations

Central contacts

Ericka M Biagioni, PhD, RDN

252-737-5043biagionie24@ecu.edu

Locations

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27858

Contacts

Ericka M Biagioni, PhD, RDN

252-737-5043biagionie24@ecu.edu

Linda May, MS, PhD

252-737-7072mayl@ecu.edu

More Information

Sponsor

East Carolina University

Last update posted

Apr 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by East Carolina University on 2026-04-13.