Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition in Children 6-60 Months of Age in Southern Ethiopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,600
- 试验地点
- 2
- 主要终点
- Survival Analysis
研究概览
简要总结
Supplementary feeding programs for children with moderate acute malnutrition have been implemented in developing countries using treatment foods with minimal or no evidence of their effectiveness. Fortified peanut paste is a popular new treatment food for children with severe and moderate malnutrition.
Objectives: To investigate the relative effectiveness of two non-identical therapeutic foods in children with moderate malnutrition by comparing differences in performance indicators (i.e. recovery rates), recovery times, and change in weight-for-height z-scores in each group.
This proposed research project will evaluate the relative effectiveness of two non-identical treatment foods for the treatment of moderate acute malnutrition in children
详细描述
This research protocol will be embedded as a component of the UN World Food Programme (WFP) -supported Supplementary Feeding programmes in Ethiopia. The proposed study is a prospective cluster-randomized equivalence trial that will compare the relative effectiveness of two feeding interventions in four woredas (districts). Research will be implemented in two comparable woredas (one with CSB and one with RUSF), in two different areas in Sidama zone that represent different livelihood zones, main source of crop income, and level of food insecurity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children 6 to 60 months of age who are identified as malnourished based on MUAC measurements with WFH ≥70 to <80%.
排除标准
- •Children with WFH < 70% or presenting with bilateral pitting oedema (they will be referred to therapeutic feeding programme).
- •Children with any illness or clinical condition that prevents them from safely ingesting either supplementary foods. A child is medically assessed upon admission for any complicated clinical condition (oedema, malaria, vomiting, chronic diarrhea, infections, appetite, etc) that would require medical care and those children will be referred to the therapeutic feeding programme.
- •All children transferred from the therapeutic feeding programme directly into the supplementary feeding programme - however they will not be included in the research study.
- •Children with WFH > 80% but MUAC 110 to 120 mm- they will be admitted to SFP however will not be included in the research study.
结局指标
主要结局
Survival Analysis
时间窗: Baseline and at 16 Weeks
Recovery rates in children from malnutrition
次要结局
- Anthropometrics Changes(Baseline, Weeks 2,4,6,8,10,12,14,16)
- Household Practices Questionnaire(At 16 weeks)
研究者
Stanley Zlotkin
Chief, Global Child Health
The Hospital for Sick Children