Monitoring and Evaluation of Micronutrients (Sprinkles) Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 610
- 试验地点
- 1
- 主要终点
- Number of Participants With Moderate to Severe Anemia
研究概览
简要总结
The purpose of this study is 1) to evaluate the effectiveness in reducing anemia among children 6-24 months of age by providing daily micronutrient Sprinkles through the Government of Pakistan's Lady Health Worker program; 2) to assist in the monitoring the National Sprinkles Pilot Project.
详细描述
According to the recent National Nutrition Survey in Pakistan (2001-2002), approximately 66.5% of children under five have anaemia.
Looking at the magnitude of the problem, National Program for Family Planning (FP) and Primary Health Care (PHC) (also known as the Lady Health Workers (LHW) Program) has developed National Sprinkles Pilot Project Proposal with technical assistance of Micronutrient Initiative and Aga Khan University (AKU). As the projects technical partner, AKU is responsible to conduct the monitoring and evaluation of the project.
The study will use a cluster randomized pre-post intervention design that compares before and after hemoglobin (Hb) measurements, serum ferritin, serum retinol and urinary iodine among children who received Sprinkles and age-appropriate feeding advice (Sprinkles-Advice group) and children who only receive age-appropriate feeding advice (Advice-only group). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits. However, intervention LHWs, will give additional advice regarding the benefits of Sprinkles and its appropriate use.
The target population selected for the study consisted of children between the ages of six and eighteen months of age in the catchment area of the Lady Health Workers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child's mother gives written consent after hearing an explanation of the study
- •Random selection of child in household with more than one eligible child
排除标准
- •Any household in which consent is not given
- •Children with any congenital or physical disability (such as cleft palate, Down's Syndrome, etc.)
- •Child from a family which intends to migrate during the study period
研究组 & 干预措施
Intervention
Multiple micronutrient fortificant (Sprinkles) and nutrition education given by LHWs.
干预措施: SPRINKLES (Dietary Supplement)
Intervention
Multiple micronutrient fortificant (Sprinkles) and nutrition education given by LHWs.
干预措施: Nutrition education (Behavioral)
Control
Routine public health massages by Lady Health Workers (LHWs) during their community visits.
结局指标
主要结局
Number of Participants With Moderate to Severe Anemia
时间窗: Baseline Hb taken at time of enrollment; Endline Hb taken 4-5 months post enrollment
number of participants with moderate - severe anemia defined as Hb \< 10g/dL
Number of Participants With Anemia
时间窗: Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment
number with mild to severe anemia (hemoglobin(Hb)\<11g/dL)
Mean Hemoglobin of Participants Post Intervention
时间窗: Endline Hb taken 4-5 months post enrollment
次要结局
- Percentage of Underweight Participants(Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment)
- Vitamin A Status of Participants - Post Intervention(Measurement taken 4-5 months post enrollment)
- Percentage of Participants With Stunted Growth(Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment)
- Percentage of Participants With Wasted Growth(Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment)
- Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention(Measurement taken 4-5 months post enrollment)
研究者
Dr Zulfiqar Ahmed Bhutta
Founding Director, Centre of Excellence in Women and Child Health
Aga Khan University