Effectiveness and Cost-effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Malnutrition in Children Between 6-36 Months in Urban Chad
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Cumulative wasting incidence, hemoglobin concentration
研究概览
简要总结
The overall objective of this project is to assess the effectiveness and cost-effectiveness of RUF (ready-to-Use Food, Plumpy Doz(r)) to prevent moderate acute malnutrition in children aged 6-36 months if embedded in a program of conditional household food assistance.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •WH≥80% of median of NCHS reference without bilateral pitting oedema;
- •Age ≥ 6 months and ≤36 months;
- •Member of a household with a dependency ratio >4;
- •Not planning to leave the study zone for the coming 5 months;
排除标准
- •Not showing appetite;
- •Age < 6 months or age > 36 months
- •Weight-for-Height Z-score <-2 and/or the presence of bilateral pitting oedema in children 6-36 months;
- •Member of a household with a dependency ration ≤ 4;
- •Clinical complications
- •Presence of chronic illness, cardiac disease, congenital abnormalities, cancer;
- •Being allergic to one of the ingredients of the RUF.
研究组 & 干预措施
Food-for-Training component
Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children.
干预措施: Food-for-Training (Behavioral)
Food-for-Training + RUF (Plumpy Doz(r))
Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children.
In addition, a blanket supplementation with 47g RUF (Plumpy Doz(r)) per day per child is provided.
干预措施: Plumpy Doz(r) - Ready-to-Use Food (Dietary Supplement)
Food-for-Training + RUF (Plumpy Doz(r))
Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children.
In addition, a blanket supplementation with 47g RUF (Plumpy Doz(r)) per day per child is provided.
干预措施: Food-for-Training (Behavioral)
结局指标
主要结局
Cumulative wasting incidence, hemoglobin concentration
时间窗: monthly
次要结局
- weight gain(monthly)
- time to become wasted(monthly)
- default rate(monthly)
- RUF acceptability(monthly)
- dietary intake(monthly)
研究者
Lieven Huybregts
Principal Investigator
University Ghent