Hydration Status and Cognitive Performance in Adolescents

NCT03483831 | Completed

• 1 other identifier: FLUIDA-MENTE
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Hydration status

  The hydration status is measured through urinary osmolality test, which indicates the solute concentration to kilograms solvent ratio (mOsm/kg): a value over 800 mOsm / kg indicates dehydration status, a value lower than 800 mOsm / kg indicates normal hydration status.

  Five months. From January to May.

Secondary Outcomes (1)

• Cognitive performance

  Five months. From January to May.

Study Arms (2)

Intervention group

EXPERIMENTAL

Students of 5 secondary school classes aged 12-14

Behavioral: Intervention group

Control group

NO INTERVENTION

Students of 5 secondary school classes aged 12-14

Interventions

Intervention group BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All secondary school students aged 12-14

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

Study Officials

• Alexis E Malavazos, MD, PhD

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leader of the High Speciality Center for Dietetics, Nutritional Education and Cardiometabolic Prevention

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 30, 2018
• Study Start: January 15, 2018
• Primary Completion: January 19, 2018
• Study Completion: May 30, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)