MAHAY Study 2015, Midline - Madagascar

Abstract
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The MAHAY study uses a multi-arm randomized-controlled trial (RCT) to test the cost-effectiveness of combined interventions to address chronic malnutrition and poor child development. The arms of the trial are: (T0) existing community-based nutrition program with monthly growth monitoring and nutritional/hygiene education; (T1) is T0 + home visits for intensive nutrition counseling within a behavior change framework; (T2) is T1 + lipid-based supplementation (LNS) for children 6-18 months old; (T3) is T2 + LNS supplementation of pregnant/lactating women; and (T4) is T1 + intensive home visiting program to support child development.

Trial Registration: Current Controlled Trials ISRCTN14393738. Registered June 23, 2015.

Geographic coverage
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5 regions

Analysis unit
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Pregnant women, children 0-12 months old and respective households

Universe
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Target population: pregnant women and children eligible to attend the national community based nutrition program

Kind of data
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Sample survey data [ssd]

Sampling procedure
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Our sampling frame is the universe of community nutrition project sites in the target regions of the program. From this universe of project communities, we drew a sample of communities that was randomly assigned to five groups. The comparison group for our study is the program as currently designed (as opposed to no program in most of the evaluation literature). In the four randomized arms, we have sequentially added increasing levels of intensity and complexity to the current intervention, starting with the lowest cost option and incrementally adding layers of intensity (and cost) to test the value added of each layer in terms of their ability to reduce stunting/growth faltering and promote child development.

Sampling deviation
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Our sample of interest is the cohort of children (and their households) sampled at baseline and followed longitudinally at midline and at endline survey. The sample was drawn from the census of children enrolled in the community-based intervention in December 2013 and updated in May 2014 in preparation for the baseline fieldwork. A sample of 3,738 households with either pregnant women or with children aged 0-11 months old was selected at baseline. At midline and endline tracking protocols were put in place with the objective to minimize attrition and preserve a sample that reflected the target population of children in the program site.

The following tracking criteria were followed:
* if the pregnant woman had a miscarriage or died, or if the target child had died, the household was considered as lost
* if the target child had temporarily moved within the catchment area of the program sites, the child should be located and interviewed
* If the target child has moved outside the catchment area (and therefore not eligible to receive the services), the household would be replaced with a household randomly chosen from within the same age group
* if the target child returned to the original household after their temporary migration at endline, both the original household and its replacement household at midline were interviewed at endline.

Mode of data collection
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Computer Assisted Personal Interview [capi]

Research instrument
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The following questionnaires were used for data collection
- Midline ACN
- Midline Enfant
- Midline Ménage et Femme
- Midline Village

The questionnaires were administered in French and they are provided in pdf for download.

摘要
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MAHAY 研究（MAHAY Study）采用多臂随机对照试验（Multi-arm Randomized-controlled Trial, RCT）的方法，以检验综合干预措施在解决慢性营养不良和儿童发育不良方面的成本效益。试验的各臂分别为：（T0）现有基于社区的营养项目，包括每月的生长监测和营养/卫生教育；（T1）T0 + 在行为改变框架内进行密集的营养咨询的家庭访问；（T2）T1 + 为 6-18 个月大的儿童提供基于脂质的补充剂（Lipid-based Supplementation, LNS）；（T3）T2 + 为孕妇/哺乳期妇女提供 LNS 补充剂；（T4）T1 + 支持儿童发展的密集家庭访问计划。
试验注册：当前对照试验 ISRCTN14393738。注册日期：2015 年 6 月 23 日。
地理覆盖范围
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5 个地区
分析单元
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孕妇、0-12 个月大的儿童及其相应家庭
总体
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目标人群：符合国家社区营养项目参与资格的孕妇和儿童
数据类型
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样本调查数据 [ssd]
抽样程序
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我们的抽样框架是项目目标地区社区营养项目总体。从该总体项目社区中，我们随机抽取了样本社区，并将其分配到五个组中。我们研究的比较组是当前设计的项目（与大多数评估文献中的无项目相比）。在四个随机臂中，我们按顺序增加了当前干预措施的强度和复杂性，从最低成本选项开始，逐步增加强度（和成本）层次，以测试每一层在减少生长迟缓/生长停滞和促进儿童发展方面的附加值。
抽样偏差
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我们感兴趣的样本是在基线、中线和终点调查中进行纵向跟踪的儿童队列（及其家庭）。样本来自 2013 年 12 月社区干预项目中登记的儿童普查，并于 2014 年 5 月更新，为基线现场工作做准备。在基线时，选定了 3,738 户家庭，其中包含孕妇或 0-11 个月大的儿童。在中线和终点跟踪中，实施了跟踪方案，目的是最大限度地减少流失并保持一个反映项目地点目标儿童人群的样本。
以下跟踪标准被遵循：
* 如果孕妇发生流产或死亡，或者目标儿童死亡，则该家庭被视为丢失
* 如果目标儿童暂时迁移到项目地点的范围内，则应找到并采访该儿童
* 如果目标儿童迁移到范围外（因此不符合接受服务资格），则用从同一年龄组中随机选择的另一个家庭替换该家庭
* 如果目标儿童在终点调查后返回到原来的家庭，则在中线调查时替换的家庭和基线调查时的原家庭在终点调查时都接受了采访。
数据收集方式
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计算机辅助个人访谈 [capi]
研究工具
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以下问卷用于数据收集
- 中线儿童营养状况问卷 (ACN)
- 中线儿童问卷 (Enfant)
- 中线家庭和女性问卷 (Ménage et Femme)
- 中线村庄问卷
问卷以法语进行管理，并提供 pdf 格式下载。