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Clinical Trials/NCT07525193
NCT07525193RecruitingNot Applicable

PREnatal Choline and Infant Outcomes Study

East Carolina University1 site in 1 country102 target enrollmentStarted: May 15, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
102
Locations
1
Primary Endpoint
Dietary choline consumption

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Choline Nutrition Education

Experimental

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

Intervention: Choline nutrition education (CNE) (Behavioral)

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.

Outcomes

Primary Outcomes

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

  • Infant body fat(At 1-month postnatal: Infant body composition will be evaluated at 1-month by DXA scan.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ericka Biagioni

Principal Investigator

East Carolina University

Study Sites (1)

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