Clinical trial NCT04265300: Hydration Intervention in Children
Official title: Nutrition, Urinary Markers and Sleep Habits in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration in Children
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 46
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators are conducting this research study to determine learn how daily habits and fluid choices impact children's health, sleep, cognitive function and mood. The investigators look to determine if a hydration intervention using an alternative beverage may impact these variables in children.

Maintaining an appropriate level of hydration throughout the day has multiple health benefits. Maintaining a desirable hydration status improves overall health and wellbeing (mood, reaction time, sleep quality, cognitive function, etc.) in adults, but negative health and mental effects of hypohydration are not fully understood in an adolescent population. Maintaining appropriate hydration in adolescents presents unique challenges with respect to schedule (e.g. the availability of fluid during the school day and after school activities) as well as ensuring the most beneficial beverage choice. Adolescents can be very meticulous regarding their preferred beverage (e.g. choosing a sugary drink over water) and parents prefer their children consume the healthiest option for their food and beverages, often times leading to conflict.

Therefore the purpose/goal of the proposed study is to determine if a hydration intervention using an alternative sweetened beverage will improve hydration and other overall health (e.g. cognitive function, sleep quality, mood etc.)

The investigators hypothesize, that by giving children an alternative tasty option, they will consume more fluids which may lead to improving and maintaining their chronic hydration state. Implementing a beverage intervention with a sweet alternative option (i.e. Creative Roots) could improve hydration levels in adolescents. In turn, possibly improving mood, reaction time, sleep quality, and cognitive function. All of which are vital in the overall development of the adolescent.


Eligibility criteria: Inclusion Criteria:

* males and females
* aged 7-12 years old
* Guardians must also meet the criteria which is that

  * 1) they shop at Whole Foods, Costco, or Trader Joe's
  * 2) they use organic ingredients \&
  * 3) they check the nutritional content on foods for their children.

Exclusion Criteria:

* prior diagnosis of cognitive or learning disabilities
* history of chronic kidney disease,
* diabetes
* sleep disorders
* use of medications that may alter water balance (e.g. diuretics, laxatives, antacids, anti-histamines, NSAIDs, blood pressure medication)
* mood and anxiety medications (e.g. antidepressants, anxiolytics, beta-blockers, ADHD medications).
* Other medications that can cause urine color changes include isoniazid, sulfasalazine, metronidazole, nitrofurantoin, amitriptyline, cimetidine, indomethacin, zaleplon, methocarbamol, metoclopramide, warfarin, rifampin, and phenazopyridine
* Participants who do not like the Creative Roots beverage

Primary outcomes:
measure: Hydration Status Change
timeFrame: 7 weeks
Secondary outcomes:
measure: Sleep Change
timeFrame: 7 weeks
measure: Cognitive functioning Change
timeFrame: 7 weeks
measure: Cognitive functioning Change
timeFrame: 7 weeks
measure: Mood Change
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
References: