Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hydration Status and Cognitive Performance in Adolescents (SMARTH2O)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483831
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Alexis Elias Malavazos, IRCCS Policlinico S. Donato

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.


Condition or disease Intervention/treatment Phase
Hydration Status Behavioral: Intervention group Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Hydration Status on Cognitive Performance in Adolescents Aged 12-14
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : January 19, 2018
Actual Study Completion Date : May 30, 2018

Arm Intervention/treatment
Experimental: Intervention group
Students of 5 secondary school classes aged 12-14
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.

No Intervention: Control group
Students of 5 secondary school classes aged 12-14



Primary Outcome Measures :
  1. Hydration status [ Time Frame: Five months. From January to May. ]
    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.


Secondary Outcome Measures :
  1. Cognitive performance [ Time Frame: Five months. From January to May. ]
    Correlation and the variation between hydration status and cognitive performances (attention, memory and concentration).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All secondary school students aged 12-14

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483831


Locations
Layout table for location information
Italy
IRCCS Policlinico San Donato
San Donato Milanese, Milan, Italy, 20097
Sponsors and Collaborators
IRCCS Policlinico S. Donato
Investigators
Layout table for investigator information
Principal Investigator: Alexis E Malavazos, MD, PhD IRCCS Policlinico San Donato

Layout table for additonal information
Responsible Party: Alexis Elias Malavazos, Leader of the High Speciality Center for Dietetics, Nutritional Education and Cardiometabolic Prevention, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier: NCT03483831    
Other Study ID Numbers: FLUIDA-MENTE
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No