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Hydration Status and Cognitive Performance in Adolescents

NCT03483831 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2018-09-05

No results posted yet for this study

Summary

Objective: to evaluate hydration status and his impact on cognitive performance in adolescents-based cohort study.

Methods: A randomized controlled pilot study is active in ten classes of one middle school (n=214 adolescents aged 12-14; including dismissed students) in an urban area around Milan, five classes being assigned to the intervention group and five classes to the control group. The five school-months intervention (from January to May 2018) includes changes in class environment (water dispenser to refill constantly, re-usable water bottles and educational posters about water consumption) and individual reinforcement tools (text messages and school lessons). The main endpoint is going to be the hydration status with osmolality urine test (dehydration status≥800 mOsm/kg). The secondary endpoint is going to be the correlation between the hydration status and cognitive performance (attention, short-term memory and concentration) through administration of neuropsychological tests from Neuropsychological Assessment Battery for Adolescence (BVN 12-18).

Results: it is expected an improvement of hydration status in intervention group versus control group and positive effects of a correct hydration on cognitive performance.

Conditions

  • Hydration Status

Interventions

BEHAVIORAL

Intervention group

Refillable water dispensers will be placed in each class of the intervention group to facilitate water access: every class will receive 5 bottles (18 Liters/each) per week for a total of 5 months. Every student will receive a re-usable water bottle.

Sponsors & Collaborators

  • IRCCS Policlinico S. Donato

    lead OTHER

Principal Investigators

  • Alexis E Malavazos, MD, PhD · IRCCS Policlinico S. Donato

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2018-01-19
Completion
2018-05-30

Countries

  • Italy

Study Locations

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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 NCT03483831 on ClinicalTrials.gov