102 Participants NeededMy employer runs this trial

Choline Nutrition Education for Pregnancy

(PRECIOUS Trial)

EM
Overseen ByEricka M Biagioni, PhD, RDN
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: East Carolina University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Healthy pregnant individual
I am between 18 and 40 years old.
Singleton pregnancy
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Exclusion Criteria

I do not have any illness or condition that could affect my baby's development.
I am over 40 years old.
Food allergy to choline-rich foods (i.e., eggs)
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Choline Nutrition Education

Participants receive choline nutrition education between gestational weeks 16 through 36

20 weeks
Multiple visits for dietary recalls and blood sampling

Usual Care

Control group receives intervention materials at 36 weeks of gestation after completion of all 36-week measures

20 weeks

Follow-up

Participants are monitored for infant body composition and maternal outcomes post-intervention

1 month postnatal
DXA scan for infants, BOD POD for maternal body composition

What Are the Treatments Tested in This Trial?

Interventions

  • Choline nutrition education (CNE)

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Choline Nutrition EducationExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

East Carolina University

Lead Sponsor

Trials
111
Recruited
42,400+