Food Aid Quality Review Phase II Effectiveness Study: Preventing MAM and Stunting in Burkina Faso
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,039
- 试验地点
- 1
- 主要终点
- Incidence of MAM and Stunting
研究概览
简要总结
This research will serve as a follow-up on the review of Title II commodities performed by the Food Aid Quality Review at Tufts University in October 2011. The study in Burkina Faso will test the relative effectiveness and cost effectiveness of four supplementary foods in the prevention of MAM and stunting in normal programmatic settings.
The aims of this study are to:
- To compare the effectiveness of four alternative supplementary food commodities in preventing stunting and wasting, and promoting linear growth in children 6 - 23 months in the context of a preventive supplementary feeding program in Burkina Faso.
- To estimate the relative cost of implementing the supplementary feeding program using each commodity
- To estimate the relative cost/effectiveness of implementing the program using each commodity.
详细描述
Phase II of FAQR in Burkina Faso will assess the recommended improvements in the four arms of the study: CSB14 prepared with FVO, RUSF1, CSB+, and SC+.
The study will be a cluster-randomized, effectiveness trial. The study will use a mixed method technique of quantitative and qualitative data collection. The design of the study is quasi-experimental: food distribution sites (FDPs) (and the communities they serve) will be grouped into four clusters that are geographically contiguous with each other and sufficiently distant from each other so that the Beneficiaries are unlikely to have contact with each other. The four groups of food distribution points will be randomly assigned to one of four arms, defined by the specific food to be provided:
- Corn Soy Blend 14 (CSB14) (with whey protein concentrate and enhanced micronutrient profile), prepared with fortified vegetable oil (FVO); 75g CSB14/day, 22.5g FVO/day
- Ready-to use supplementary food 1 (RUSF1); 100g RUSF/day
- Super Cereal Plus (SC+)( has an enhanced nutrient profile, non-fat dry milk, and oil already embedded into the CSB); 122g SC+/day
- Corn Soy Blend Plus (CSB+) prepared with FVO; 75g CSB+/day, 22.5g FVO/day The CSB+ arm will act as a control
The intervention is implemented using the food distribution points providing supplementary food (CSB14, CSB+, RUSF, SC+) to children once they reach six months of age, and children from 6 to 23 months. This study will enroll all children as they turn six months of age and follow them through their 23rd month of age. Variables to be tracked include: age, sex, arm of study/commodity received ,Mid-Upper Arm Circumference (MUAC), height for age, weight for age, weight for height, month-to-month linear growth and weight gain, incidence of stunting (height for age below -2 Standard Deviations (SD)), incidence of wasting (weight for height below - 2 SD).
At 24 months, children stop receiving supplementary food. The study will continue to monitor these variables for at least an additional 6 months (through the age of 30 months).
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 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CSB14
Isocaloric amount and cost-effectiveness of CSB14 (with whey protein concentrate and enhanced micronutrient profile), prepared with fortified vegetable oil (FVO).
干预措施: CSB14 (Dietary Supplement)
RUSF1
Isocaloric amount and cost-effectiveness of Ready-to Use Supplementary Food 1(RUSF1), USAID's Lipid-Based Nutrient Supplement (LNS) product
干预措施: RUSF1 (Dietary Supplement)
SC+
Isocaloric amount and cost-effectiveness of Supercereal Plus (SC+), the FBF used by WFP, which has an enhanced nutrient profile, dairy ingredient (non-fat dry milk), and oil already embedded into the flour
干预措施: SC+ (Dietary Supplement)
CSB+
Isocaloric amount and cost-effectiveness of Supercereal/CSB+ prepared with FVO.
结局指标
主要结局
Incidence of MAM and Stunting
时间窗: Monthly for 18 months
Primary outcomes to be measured are incidence of MAM and incidence of stunting during the 18 months of preventive supplementation (age 6 months to 23 months). Stunting will be defined as less than -2 SD of Height-for-Age Z-score and MAM will be defined as less than -2 SD Weight-for-Height (length) Z-score
次要结局
未报告次要终点