A Pilot Randomized Controlled Trial to Promote Healthful Fish Consumption in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Plasma elongated n-3 PUFA levels
研究概览
简要总结
The overall goal of this project is to establish a pilot study to develop and refine an intervention to promote consumption of fish low in mercury and high in n-3 PUFA among pregnant women. The investigators will demonstrate our ability to recruit pregnant women, influence their fish consumption, and measure changes in nutrient and toxicant biomarkers.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 18 years or older
- •Currently pregnant 12-22 weeks
- •Singleton pregnancy
- •Consuming fish <=2 times per month
排除标准
- •Inability to answer questionnaires in English
- •Plans to leave study area prior to delivery
- •Would never eat fish (e.g. vegan, allergy to fish)
研究组 & 干预措施
Dietary advice and grocery store card
Dietary advice to consume low mercury, high DHA fish plus a grocery store gift card to support the purchase of fish
干预措施: Dietary advice (Behavioral)
Dietary advice
Dietary advice regarding consumption of low mercury, high DHA fish
干预措施: Dietary advice (Behavioral)
Control
General dietary advice not focused on fish intake
干预措施: Control (Behavioral)
结局指标
主要结局
Plasma elongated n-3 PUFA levels
时间窗: 12 weeks
Change in plasma levels of elongated n-3 PUFA from recruitment to follow up at 12 weeks
次要结局
- Whole blood mercury(12 weeks)
- Fish consumption(12 weeks)
研究者
Emily Oken
Associate Professor
Harvard Pilgrim Health Care