Study of Dehydration and Cognition in Pupils in Zambia

NCT01924546 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2019-05-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Water

1.5 L bottle of water provided in the morning of the school day, with refills provided during the course of the day.

Sponsors & Collaborators

  • FHI 360

    collaborator OTHER
  • United States Agency for International Development (USAID)

    collaborator FED
  • Emory University

    lead OTHER

Principal Investigators

  • Matthew C Freeman, PhD MPH · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Zambia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01924546 on ClinicalTrials.gov