PREnatal Choline and Infant Outcomes Study
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
- 是
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
Participants will receive choline nutrition education (CNE) between gestational weeks 16 through 36.
干预措施: Choline nutrition education (CNE) (Behavioral)
Usual Care
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
Ericka Biagioni
Principal Investigator
East Carolina University
