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临床试验/NCT07525193
NCT07525193招募中不适用

PREnatal Choline and Infant Outcomes Study

East Carolina University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
102
试验地点
1
主要终点
Dietary choline consumption

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy pregnant individual
  • Singleton pregnancy
  • 18-40 years of age
  • Pre-pregnancy BMI ≥ 18.5

排除标准

  • 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

研究组 & 干预措施

Choline Nutrition Education

Experimental

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

干预措施: 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.

结局指标

主要结局

Dietary choline consumption

时间窗: 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

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ericka Biagioni

Principal Investigator

East Carolina University

研究点 (1)

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