Study of Dehydration and Cognition in Pupils in Zambia

NCT01924546 | Completed

• 1 other identifier: IRB00065861
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief 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

Dehydration

Keywords

cognition; hydration; schoolchildren

Outcome Measures

Primary Outcomes (1)

• Change in cognitive test performance

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

  Baseline and 5-8 hours following intervention

Secondary Outcomes (2)

• Change in perceived difficulty of task

  Baseline and 5-8 hours following intervention

• Change in hydration status

  Baseline and 5-8 hours following intervention

Study Arms (2)

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.

Other: Water

Control

NO INTERVENTION

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

Interventions

Water OTHER

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

Supplementary water

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Unable to write down a string of numbers

Sponsors & Collaborators

• Emory University: lead
• FHI 360: collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Chipata

Chipata, Zambia

Location

Related Publications (1)

• Trinies V, Chard AN, Mateo T, Freeman MC. Effects of Water Provision and Hydration on Cognitive Function among Primary-School Pupils in Zambia: A Randomized Trial. PLoS One. 2016 Mar 7;11(3):e0150071. doi: 10.1371/journal.pone.0150071. eCollection 2016.

  PMID: 26950696 RESULT

MeSH Terms

Conditions

Dehydration

Interventions

Water

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Matthew C Freeman, PhD MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 16, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

ZA (1)