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临床试验/NCT01882335
NCT01882335Unknown不适用

Saving Brains In Uganda And Burkina Faso (PROMISE Saving Brains)

Makerere University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
Cognitive function

研究概览

简要总结

The study will estimate the effect of peer-counseling for exclusive breast feeding (EBF) in the first 6 months of life on cognition and other determinants of human capital formation including behavioral and emotional status; school readiness and attainment; health status; fine and gross motor skills; physical growth; and household economic status.

详细描述

Between 2006 and 2008 we carried out a cluster randomized study (PROMISE-EBF) to establish the effect of individual home based peer counselling on exclusive breast feeding (EBF). The results, published in the Lancet in 2011 were remarkable(Tylleskar T, et al). The PROMISE-EBF trial which compared mothers in the intervention arm that were offered at least 5 peer-visits promoting EBF to mothers in the control arm, that received the standard of care showed a doubling in the prevalence of EBF in the intervention arm. Community-based peer counsellors increased the EBF rate in Uganda and Burkina Faso from about 40% to 80%.

The current study will trace and re-enrol at least 70% of the children involved in the PROMISE-EBF study. These children are now aged between 5 and 7 years.

The primary objective of the current study is to evaluate the effect of peer-counselling for EBF in the first six months of life on human capital formation among children in Uganda and Burkina Faso.

This study will contribute to a crucial wider discussion on external validity regarding the relationship between EBF and intellectual performance and mental health. In the social area, this study will identify solutions to potential barriers that limit scale up for peer-counselling for EBF. From the business perspective, the study will identify the best business model for affordable, acceptable and cost effective ways of delivering peer counselling for EBF in Burkina Faso and Uganda. If this intervention is found effective, and is adopted, it could improve productivity in adulthood and work towards breaking the cycle of poverty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children whose mothers participated in the original intervention of peer support for exclusive breastfeeding (EBF).
  • Informed caregiver consent

排除标准

  • 未提供

结局指标

主要结局

Cognitive function

时间窗: one year

Proportion of children with impaired cognitive function in intervention compared to the control group

次要结局

  • Cost-effectiveness of promoting peer-counselling for exclusive breastfeeding in the first six months of life to support human capital formation(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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