search
Back to results

Hydration Intervention in Children

Primary Purpose

Dehydration in Children

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Creative Roots
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dehydration in Children

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Connecticut

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Creative Roots

Arm Description

No intervention provided

The intervention group will receive Creative Roots beverages and be instructed to have at least one drink (251mL) available at each meal (i.e. breakfast, lunch, and dinner) and drink as much as they would like throughout the day (i.e. ad libitum) of either Creative Roots or any other beverage they would normally consume. Subjects will be asked the keep their empty Creative Roots bottles to return them to the lab. Subjects will be instructed to refrigerate the beverages for better taste, and to refrigerate the beverages after opening.

Outcomes

Primary Outcome Measures

Hydration Status Change
Change in WUT Score (Weight Urine and Thirst)

Secondary Outcome Measures

Sleep Change
Change in quantity
Cognitive functioning Change
Change in Go-no-go test score
Cognitive functioning Change
Change in modified flanker task score
Mood Change
Change in Modified Mood Questionnaire Score

Full Information

First Posted
February 3, 2020
Last Updated
June 13, 2020
Sponsor
University of Connecticut
search

1. Study Identification

Unique Protocol Identification Number
NCT04265300
Brief Title
Hydration Intervention in Children
Official Title
Nutrition, Urinary Markers and Sleep Habits in Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration in Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention provided
Arm Title
Creative Roots
Arm Type
Experimental
Arm Description
The intervention group will receive Creative Roots beverages and be instructed to have at least one drink (251mL) available at each meal (i.e. breakfast, lunch, and dinner) and drink as much as they would like throughout the day (i.e. ad libitum) of either Creative Roots or any other beverage they would normally consume. Subjects will be asked the keep their empty Creative Roots bottles to return them to the lab. Subjects will be instructed to refrigerate the beverages for better taste, and to refrigerate the beverages after opening.
Intervention Type
Dietary Supplement
Intervention Name(s)
Creative Roots
Intervention Description
The Creative Roots beverage is a coconut water-based drink with three flavors Mixed Berry, Watermelon Lemonade, and Peach Mango. The ingredients are as follows and are the same for all three flavors: water, coconut water concentrate, citric acid, stevia leaf extract, natural flavor, rosemary extract (to preserve flavor). Contains: coconut
Primary Outcome Measure Information:
Title
Hydration Status Change
Description
Change in WUT Score (Weight Urine and Thirst)
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Sleep Change
Description
Change in quantity
Time Frame
7 weeks
Title
Cognitive functioning Change
Description
Change in Go-no-go test score
Time Frame
7 weeks
Title
Cognitive functioning Change
Description
Change in modified flanker task score
Time Frame
7 weeks
Title
Mood Change
Description
Change in Modified Mood Questionnaire Score
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hydration Intervention in Children

We'll reach out to this number within 24 hrs