跳至主要内容
临床试验/NCT04222998
NCT04222998已完成不适用

Impact of Home-based Growth Charts on Child Linear Growth in Indonesia

Boston University1 个研究点 分布在 1 个国家目标入组 1,487 人开始时间: 2022年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,487
试验地点
1
主要终点
Child height for age z-score (HAZ)

研究概览

简要总结

The investigators developed a home-based growth chart that offers a simple and inexpensive way for caregivers to have access to simple health and nutrition information guided by behavioural economics analysis as well as to track their child's linear growth, empowering them to act to improve their child's nutrition. Results from a pilot study conducted in rural Zambia suggest that growth charts installed in homes can increase awareness and reduce early-life growth deficits, particularly among children experiencing growth faltering. The main objective of this study is to assess the impact and cost-effectiveness of growth charts through a cluster-randomized trial in Indonesia. The primary outcome is child height-for-age z-score.

详细描述

The study is divided into two phases. In the first phase, growth chart development activities will be conducted in two villages in each of Manggarai Timur and Trenggalek districts to ensure the chart design is compatible with the local context and chart information is understandable to caregivers. Focus group discussions (FGDs), key informant interviews (KIIs), and door-to-door user testing will be conducted in each village. Results from the FGDs and KIIs will inform a draft growth chart design that will then be user tested in 10 households in each village. Qualitative interviews will be conducted with each household approximately two weeks after chart installation to gather insights on the usability of the growth chart. The chart design will then be finalized for use in the second phase of the study.

In the second phase, 1,480 caregiver-child dyads will be recruited and enrolled in the study as part of a baseline survey. Dyads will be sampled using a two-stage procedure. 110 villages will be selected proportionate to national census population size. All sub-villages ("dusun") within selected villages will be randomly assigned into two groups: 1) Growth chart; and 2) Control. Eligible caregiver-child dyads with children between 9 and 14 months will be selected from each sub-village.

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
9 Months 至 14 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Caregivers must be 19 - 55 years old
  • One child of either gender, 9-14 months old
  • Caregiver can have other children
  • Caregiver of any occupation and income level
  • Live in Manggarai Timur and Trenggalek during inception

排除标准

  • Caregivers with a cognitive disability

结局指标

主要结局

Child height for age z-score (HAZ)

时间窗: 12 months

Height/length data will be converted to height for age z-score (HAZ) using WHO (World Health Organization) growth standards.

Child stunting

时间窗: 12 months

Child stunting is defined as height for age z-score (HAZ) \< -2

次要结局

  • Child weight for age z-score (WAZ)(12 months)
  • Early child development (ECD)(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验