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临床试验/CTRI/2024/01/061979
CTRI/2024/01/061979尚未招募3 期

Implementation science for early childhood development in Odisha, India

University College London1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2024年2月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
700
试验地点
1
主要终点
Global Scale of Early Development (GSED) score

研究概览

简要总结

In this study, we propose to research the effects of free creches (daycare centres) months on the development and nutrition of children aged 6 to 36 months living in the rural district of Keonjhar in Odisha, Eastern India. Ekjut manages over 50 creches for children aged 6 to 36 months in Keonjhar. The creches have clean water, are smoke-free, serve two hot cooked meals per day, provide stimulating activities for children, and also serve as hubs for parents’ meetings where creche workers discuss good health, nutrition, protection, and stimulation practices for parents of children attending the creches and others in the community.

 We will select 30 of these creches and follow up 350 children aged 6-24 months enrolled in them for 12 months, along with a group of children the same age in nearby, comparable villages. We will conduct a questionnaire interview with parents of children in both groups (those in creches and those not in creches) to capture information on families’ socio-economic characteristics, access to health and nutrition services, and how stressed parents feel in meeting their caregiving obligations. We will also children’s development and nutritional status 12 months after recruitment to understand whether creches benefit children.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Outcome Assessor Blinded

入排标准

年龄范围
6.00 Month(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 700 children aged 6-24 months at the time of the study enrolment survey and in comparable villages, as well as their primary caregivers, to be followed-up and re-interviewed 12 months after enrolment.

排除标准

  • Children with severe congenital anomalies, including severe neural tube defects and Down’s Syndrome.

结局指标

主要结局

Global Scale of Early Development (GSED) score

时间窗: Measured first when children are aged 6-24 months and then when they are 18-36 months

次要结局

  • Parental stress(12 months after recruitment)
  • Mean weight for age z scores for children(12 months after recruitment)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Shibanand Rath

Ekjut

研究点 (1)

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