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?

This trial aims to determine if educating pregnant women about choline, a nutrient vital for both maternal and infant health, can improve health outcomes. Most women lack sufficient choline, and prenatal vitamins often omit it. The trial will compare women receiving choline nutrition education (CNE) with those receiving usual care to assess effects on placental function and infant health. Pregnant women with a BMI of 18.5 or higher, carrying one baby, and without conditions like diabetes or food allergies to choline-rich foods may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to significant research that could enhance prenatal care for future mothers and babies.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this choline nutrition education is safe for pregnant women?

Research has shown that choline supplements are generally safe when used as directed during pregnancy. Pregnant women should adhere to the recommended dosages. Some individuals might experience mild side effects like stomach discomfort and nausea, but these are uncommon.

Choline plays a crucial role in the baby's brain and spinal cord development. Many pregnant women do not consume enough choline from their diet, so learning about choline-rich foods can be beneficial. Pregnant women should aim for about 450 milligrams of choline daily. Most prenatal vitamins lack choline, so it primarily comes from food sources.

The need for choline increases during pregnancy, and adequate intake supports both the mother's health and the baby's development. Although safety data is limited, following dietary guidelines and recommendations helps reduce risks.12345

Why are researchers excited about this trial?

Researchers are excited about Choline Nutrition Education (CNE) for pregnancy because it focuses on enhancing maternal and fetal health through education, rather than medication or supplements alone. Unlike standard prenatal care, which often emphasizes a wide range of nutrients, CNE specifically targets choline, a nutrient crucial for brain development and potentially reducing the risk of certain birth defects. By empowering pregnant individuals with knowledge about dietary sources of choline, this approach aims to improve nutritional intake naturally and sustainably, offering a personalized and proactive strategy that could complement traditional prenatal care.

What evidence suggests that choline nutrition education is effective for improving maternal and infant health?

Research has shown that increased choline intake during pregnancy can enhance children's cognitive development. Studies have found that choline supplements improve placental efficiency, crucial for nourishing the baby. In animal studies, choline balanced fat and sugar transport through the placenta, preventing issues like excessive fetal growth. Additionally, higher choline levels in pregnant women have been linked to benefits such as reduced body fat and improved infant health. Although not all studies concur, increasing choline intake during pregnancy appears to offer potential advantages for both mothers and babies. Participants in this trial will receive Choline Nutrition Education (CNE) to further explore these potential benefits.16789

Are You a Good Fit for This Trial?

This trial is for healthy pregnant women aged 18-40 with a single baby and a pre-pregnancy BMI of at least 18.5. People can't join if they have certain chronic illnesses, are over 40, have more than one baby, known fetal problems, or allergies to choline-rich foods like eggs.

Inclusion Criteria

Healthy pregnant individual
I am between 18 and 40 years old.
Singleton pregnancy
See 1 more

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)

Trial Overview

The study tests whether giving nutrition education about choline during pregnancy helps increase mothers' choline intake and improves outcomes for both mother and baby compared to usual care.

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+

Citations

Choline Supplementation in Pregnancy: Current Evidence ...

Studies have suggested that increased choline intake during pregnancy may positively influence cognitive outcomes in children, potentially ...

PREnatal Choline and Infant Outcomes Study

The central hypothesis is that choline education will increase maternal choline levels and improve placental function and infant health. We will ...

Choline During Pregnancy and Child Neurodevelopment - PMC

Animal studies suggest that choline supplementation during pregnancy improves cognitive outcomes in the offspring. This review aims to determine whether higher ...

Associations of choline intake and metabolite status with ...

Maternal choline supplementation in obese mice normalizes placental fat and glucose transport and prevents fetal overgrowth. In this study, we aimed to ...

Choline in Adolescent Pregnancy: The Impact on Fetal ...

Adolescent pregnant women demonstrate reduced choline clearance (0.8 ± 0.2 vs. 1.2 ± 0.3 mL/min/kg), decreased choline kinase activity (25–30% reduction), and ...

Choline During Pregnancy and Lactation | InfantRisk ...

National (U.S.) survey data indicate that the average choline intake among pregnant individuals was about 319 mg/day, and only 8.5% of pregnant women consumed ...

Selected Studies on Choline and Prenatal Health

“Choline will help your baby's brain and spinal cord develop correctly. It's recommended that women get 425 milligrams a day before getting pregnant, and 450 ...

Choline in Pregnancy and Lactation: Essential Knowledge ...

According to the European Food Safety Authority (EFSA) the nutritional needs for choline increase by 20% in pregnancy and 30% in the lactation period [33].

Choline Supplementation for Infants, Children, and Pregnant ...

During pregnancy, choline demand is higher because it plays a role in the safety of the pregnant person and in the growth and development of the fetus, the ...