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临床试验/NCT01678716
NCT01678716已完成不适用

1) Impact Evaluation of Behavior Change Communication and Micronutrient Supplementation Interventions on Infant and Young Child Feeding (IYCF) Practices and on Childhood Stunting and Anaemia 2) Evaluation of the Public Health Impact of a Market-based Approach to Improving Diet Quality of Infants and Young Children Through the Use of Sprinkles in Bangladesh

International Food Policy Research Institute2 个研究点 分布在 1 个国家目标入组 8,800 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8,800
试验地点
2
主要终点
Exclusive breastfeeding (EBF) among children 0-6 months of age

研究概览

简要总结

This complex evaluation of a large-scale program uses a cluster-randomized design where 20 geographic clusters (subdistricts) were randomized to study two sets of interventions. For the evaluation of behavior change interventions only, the 20 clusters were randomized to 10 intensive and 10 non-intensive interventions areas. For a sub-study to evaluate a market-based model for delivering micronutrient powders (MNP) along with behavior change interventions, there was subsequent randomization to comparison area, MNP-only area, Behavior Change Communication (BCC)-only area and MNP+BCC areas.

详细描述

The design uses a repeated cross-sectional design, with multiple age-group samples for multiple outcomes [since each set of outcomes can only be assessed in the relevant age group for the outcome; e.g., exclusive breastfeeding is only assessed in children 0-6 months of age]. These include:

  1. For the evaluation of behavior change intervention only:
  • 0-6 months for breastfeeding outcomes
  • 6-23.9 months for complementary feeding outcomes (in the behavior change intervention evaluation)
  • 24-48 months for child anthropometric outcomes (related to the behavior change interventions).
  1. for the substudy on behavior change and micronutrient powder interventions combined - 6-23.9 months for anemia and anthropometric outcomes

A community-based random sample of children 0-6 months, 6-23.9 months, 24-48 months old was surveyed at baseline (April-June 2010). The original anemia sub-study design had proposed surveying children 6.23.9 months of age for the MNP intervention in April-June 2013 and for the behavior change intervention in April-June 2014. Based on program implementation timelines, the endline survey dates were extended by one year such that the above age groups were then sampled and surveyed in community-based surveys in April-June 2014.

Infant feeding practices will be assessed using before-after intervention-comparison area group differences between 2010, and 2013 and 2014. Specifically, breast feeding will be assessed in children 0-6 months of age (sampled separately) and complementary feeding will be assessed in children 6-23.9 months of age (sampled separately).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
— 至 60 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Child age < 60 months

排除标准

  • 未提供

结局指标

主要结局

Exclusive breastfeeding (EBF) among children 0-6 months of age

时间窗: 4 years after baseline

EBF is among the eight WHO-recommended core indicators for infant and young child feeding and will be measured using recall-based survey measures

Complementary feeding among children 6-23.9 months of age

时间窗: 4 years after baseline

Complementary feeding indicators that include timely introduction of complementary feeding (infants 6-8 months), dietary diversity, minimum dietary diversity, minimum dietary diversity, are among the eight WHO-recommended core indicators for infant and young child feeding and will be measured using recall-based survey measures in this age group.

Child anthropometry (height, weight) among children 24-48 months of age

时间窗: 4 years after baseline

Child height and weight will be measured among the repeated cross-sectional of children living in the study villages. These will be converted into z-scores based on the WHO growth reference standards.

Anemia among children 6-23.9 months

时间窗: 4 years after baseline

Anemia will be measured using Hemocue

次要结局

  • Iron deficiency(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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