Randomized Control Trial of Complementary Food to Prevent Undernutrition Among At-Risk Infants in Fort San Michel, Haiti
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,228
- 试验地点
- 1
- 主要终点
- Change in Length for Age
研究概览
简要总结
This randomized, controlled effectiveness study examines Nutributter programming within an integrated package of maternal and child health services offered by Haiti's Ministry of Health (MSPP) to prevent undernutrition among young children in Haiti. The aim of the process evaluation is to better understand the uptake of Nutributter® as a complementary food in the diets of young children and its feasibility and acceptability as part of MSPP's package of services. This project is being carried out at a public hospital in Fort San Michel, an impoverished community outside of Cap Haitien, Haiti.
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
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants 6 to 12 months old
- •Lives in Fort San Michel
排除标准
- •Moderately or severely malnourished
- •Peanut allergy
研究组 & 干预措施
MSPP Integrated Package
Participants in this arm only receive the standard care offered by the Ministry of Health (MSPP)called the Integrated Package. During the trial, they do not receive Nutributter.
Nutributter 3 Months, Integrated Package
Participants receive a one-month supply for the first 3 months of the 6-month trial in addition to the Integrated Package.
干预措施: Nutributter Program (Dietary Supplement)
Nutributter 3 Months, Integrated Package
Participants receive a one-month supply for the first 3 months of the 6-month trial in addition to the Integrated Package.
干预措施: Integrated Package (Other)
Nutributter 6 Months, Integrated Package
Participants receive a one-month supply for each month of the 6-month trial in addition to the Integrated Package.
干预措施: Nutributter Program (Dietary Supplement)
Nutributter 6 Months, Integrated Package
Participants receive a one-month supply for each month of the 6-month trial in addition to the Integrated Package.
干预措施: Integrated Package (Other)
结局指标
主要结局
Change in Length for Age
时间窗: Once per month for 6 months, then once after 12 months.
Length (measured in centimeters) for age is an indicator of stunting, an outcome of chronic undernutrition during the first 2 years of life. Because our primary purpose is to prevent undernutrition, we are highly interested in this measurement.
次要结局
- Change in Weight for Height(Once per month for 6 months, then once after 12 months)