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临床试验/NCT01924546
NCT01924546已完成不适用

Cognitive Effects of Drinking Water and Improving Hydration Status Among Schoolchildren in Zambia

Emory University1 个研究点 分布在 1 个国家目标入组 292 人开始时间: 2013年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
292
试验地点
1
主要终点
Change in cognitive test performance

研究概览

简要总结

There is a large body of evidence from adult populations suggesting cognition in adults is affected by hydration status. The few studies conducted in the global North in populations of schoolchildren indicate that drinking water has an impact on pupil performance on basic cognitive tasks. No studies assessing the impact of dehydration and cognition in schoolchildren have been published in the global South, where access to water is the poorest and dehydration prevalence is likely higher. Our group previously carried out research on this topic in Mali, and will build upon findings from that work with this trial. This study will examine the effect of drinking supplementary water during the school day on hydration status and on cognitive test scores in schoolchildren in Zambia.

The investigators hypothesize that providing supplemental water will result in a decrease in prevalence of dehydration in the study group and will result in an improved performance on cognitive test scores.

Data will be collected from up to four purposively-selected schools in the region of Zambia where this study is taking place, from up to a total of 400 children. At each school pupils in grades 3-6 will be eligible for recruitment, dependent upon their understanding of research instructions. Research staff will explain the study to pupils at the school and individually request informed oral assent for participation. A waiver of parental consent for pupil interviews will be secured from the Ministry of Education. At each school, school directors will be asked to sign in loco parentis ("in the place of parent") on behalf of the pupil participants.

Children that assent to participate in the study will be randomly allocated to the intervention or control group. In the intervention group, study participants will receive supplementary water in the morning. In the control group, study participants will receive supplementary water in the afternoon. Testing procedures in both groups is identical and will include a five-minute interview, two cognitive testing sessions of 45 minutes each, and collection of two urine samples during the day. None of these activities collect personal data or identifiers, and the urine sample will not be stored.

All data collection will occur at the school and will be conducted by trained local enumerators. There are no risks to participation other than a small amount of class time missed by pupils, and great efforts will be made to minimize time outside of class.

详细描述

Background and Specific Aims

The purpose of this study is to evaluate the impact of improved water access on the cognitive performance and mood of primary school children in Zambia.

There is a considerable body of research assessing links between dehydration to reduction in cognitive ability and mood, but few of these studies involve children and only one such study has taken place outside of Europe. UNICEF estimates that only 47% of schools in low-income settings have access to any water during the day. Emory researchers have recently quantified the impact of improved water, sanitation, and hygiene (WASH) access in school on health and education measures, and have carried out research on cognition and dehydration in Zambia. A better understanding of the impact of water intake on hydration has importance for the growing number of school-based WASH interventions in developing countries, not only for purposes of pure scientific knowledge but also for advocacy from donors and national governments.

To this purpose, the investigators have identified the following objectives:

  • Refine a battery of cognitive tests for children in low-income settings and quantify the practice effect of repeated testing;
  • Assess the levels of dehydration among children in Zambia;
  • Quantify the effect of improved water access on hydration status and cognition; and
  • Compare different field hydration assessment techniques for accuracy and ease of use

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Attend a school pre-selected for the study
  • Attend grade level 3-6
  • Understand and respond to verbal instruction

排除标准

  • Unable to write down a string of numbers

研究组 & 干预措施

Control

No Intervention

No additional water provided during the day. Additional water provided at the end of the school day.

Supplementary water

Experimental

This arm receives up to 3 L of supplemental water during the course of the testing day plus encouragement to drink water.

干预措施: Water (Other)

结局指标

主要结局

Change in cognitive test performance

时间窗: Baseline and 5-8 hours following intervention

Measured by paper-based tests of visual attention, visual memory, short-term member, and visuomotor skills

次要结局

  • Change in perceived difficulty of task(Baseline and 5-8 hours following intervention)
  • Change in hydration status(Baseline and 5-8 hours following intervention)

研究者

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

Matthew Freeman, MPH, PhD

Assistant Professor

Emory University

研究点 (1)

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