Dehydration Among School Children- Mali

NCT01768234 | Completed

• 1 other identifier: IRB00062354
• Study Type: interventional
• Target: 120
• 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 carried out in the global South, where access to water is the poorest and dehydration prevalence is likely higher. 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 Mali, West Africa. 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 Sikasso region of Mali, from up to a total of 300 children. At each school pupils in grades 3-6 will be eligible for recruitment. 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. Data collection will take place at each school over two days within a one-week period, with one study group tested on each of the two days. On the intervention testing day, all study participants will receive supplementary water. On the control testing day, no study participants will receive supplementary water. 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)

• Cognitive test performance

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

  5-8 hours following intervention

Secondary Outcomes (2)

• Perceived difficulty of task

  5-8 hours followign intervention

• Hydration status

  5-8 hours following intervention

Study Arms (2)

Supplemental water

EXPERIMENTAL

This arm receives up to 2 L of supplemental water during the course of the testing day.

Other: Supplemental water

Control

NO INTERVENTION

No supplemental water provided

Interventions

Supplemental water OTHER

1-2L of supplemental water provided between pre-test and post-test

Supplemental water

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• 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
• Save the Children: collaborator

Study Sites (1)

Sikasso rural

Sikasso, Mali

Location

Related Publications (1)

• Chard AN, Trinies V, Edmonds CJ, Sogore A, Freeman MC. The impact of water consumption on hydration and cognition among schoolchildren: Methods and results from a crossover trial in rural Mali. PLoS One. 2019 Jan 17;14(1):e0210568. doi: 10.1371/journal.pone.0210568. eCollection 2019.

  PMID: 30653554 RESULT

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

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

Study Officials

• Matthew 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: December 19, 2012
• First Posted: January 15, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

MA (1)