Effects of Unconditional Cash Transfers on the Management of Severe Acute Malnutrition (SAM) in the Democratic Republic of Congo: a Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UNICEF
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Recovery rate in the outpatient therapeutic program
研究概览
简要总结
Cash transfer, aims to strengthen food security for vulnerable households by giving families enough purchasing power to consume an adequate and balanced diet, maintain a good standard of hygiene, access health services, and invest in their own means of food production in addition to their children's growth and development.
While cash transfer to vulnerable households has shown a long-term positive impact on growth and on malnutrition-related mortality in children aged 0-5 years, there is little conclusive evidence their effectiveness in Sub-Saharan Africa that cash transfer has a direct effect on the Community-based Management of Acute Malnutrition (CMAM). Here, the investigators will perform a cluster-randomized trial to investigate during 6 months the effects of unconditional cash transfers on the management of severe acute malnutrition (SAM) in children from 6 to 59 months according to the national protocol in the Democratic Republic of Congo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Living in the catchment area of one of the 20 outpatient therapeutic program site participating in this cluster randomized trial;
- •6-59 months of age;
- •Weight for Height Zscore <-3 SD (WHO Growth Standards 2006) and/or Mid-Upper Arm Circumference <115mm and/or with bilateral edema;
- •No major clinical complications;
- •Positive appetite test;
- •Accept to participate at the study.
排除标准
- •Not living in the catchment area of the outpatient therapeutic program site of the cluster randomized trial;
- •Weight-for-Height Z-score ≥-3 (WHO Growth Standards 2006) and Mid-Upper Arm Circumference ≥115mm without bilateral edema;
- •Major clinical complications;
- •Failure to appetite test;
- •Refuse to participate at the study.
结局指标
主要结局
Recovery rate in the outpatient therapeutic program
时间窗: At 6 week
Recovery is defined for patient of 6 to 59 months old as Weight-for-Height Z-score ≥-1.5 SD (WHO Growth Standards 2006) or Mid-Upper Arm Circumference ≥125mm at two consecutive visits and absence of bilateral edema for 14 days.
次要结局
- Weight gain(At 6 week, 8 week and 6 month)
- Mid-Upper Arm Circumference gain(At 6 week, 8 week and 6 month)
- Change in the Individual Dietary Diversity Score (IDDS)(At 6 week, 8 week and 6 month)
- Default rate in the outpatient therapeutic program(Two weeks)
- Recovery rate in the outpatient therapeutic program(At 8 week)
- Transfer rate from outpatient therapeutic program to inpatient therapeutic program(One month average)
- Length of stay in the outpatient therapeutic program(One month (average))
- Relapse rate(At 2, 3 and 4 months following discharge)
- Failure rate in the outpatient therapeutic program(Up to three months)
- Morbidity rate(At 6 week, 8 week and 6 month)
- Death rate(At 6 week, 8 week and 6 month)
- Change in Growth rates(At 6 month)
- Diet replacement & Intra-household dispatching of the therapeutic food(One month average)
- Change in the Household Dietary Diversity Score (HDDS)(At 6 month)
- Satisfaction of parents and acceptability(At 6 month)