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临床试验/NCT03483831
NCT03483831已完成不适用

Effects of Hydration Status on Cognitive Performance in Adolescents Aged 12-14

IRCCS Policlinico S. Donato1 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2018年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
214
试验地点
1
主要终点
Hydration status

研究概览

简要总结

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.

详细描述

INTRODUCTION Energy metabolism is higher per kilogram body weight in children than in adults. 1 Children aged from 11 to 14 should consume at least 1.5 liters of water per day, according to EFSA advice (European Food Safety Authority) 2.

This amount of daily water is difficult to reach because young people usually do not recognize thirst and they often haven't got an easy access to water 3.

Scientific evidence proves that a soft dehydration, as a loss 1 % of body weight, can cause reduction of concentration and cognitive performance with consequences on memory and attention in children.4,5

An English systematic study about school policies on drinking water 4 compared three different contexts: schools in which water in the classroom was prohibited, schools that allowed limited access to water (for example, the water was allowed in the classroom, but not on the desk) and schools that had open access to water (for example, water was allowed in the classroom and bottles were kept at the desk). The results showed that the percentage of children who consumed less than the recommended daily amount of fluid was significantly higher in the schools that prohibited water consumption (81%) and in the schools that had limited access to water during the school day (80%). This percentage was considerably reduced in the schools where children had free access to water (46.5%). In Italian schools generally access to water is limited and water consumption is allowed only at lunch 7.

METHODS Study Design and participants

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All secondary school students aged 12-14

排除标准

  • 未提供

研究组 & 干预措施

Intervention group

Experimental

Students of 5 secondary school classes aged 12-14

干预措施: Intervention group (Behavioral)

Control group

No Intervention

Students of 5 secondary school classes aged 12-14

结局指标

主要结局

Hydration status

时间窗: 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.

次要结局

  • Cognitive performance(Five months. From January to May.)

研究者

发起方
IRCCS Policlinico S. Donato
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexis Elias Malavazos

Leader of the High Speciality Center for Dietetics, Nutritional Education and Cardiometabolic Prevention

IRCCS Policlinico S. Donato

研究点 (1)

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