- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06259799
Efficacy of a Smart Water Bottle Intervention to Increase Fluid Consumption in College Students
August 25, 2025 updated by: Kennesaw State University
Approximately 60% of males and 40% of females do not meet current fluid intake recommendations, which is associated with adverse health consequences such as obesity, diabetes, and chronic kidney disease.
Newer technologies have been designed to promote fluid intake.
"Smart Water Bottles" use mHealth technology to capture fluid intake behaviors automatically and provide cues to encourage fluid consumption.
Studies using Smart Water Bottles have helped some individuals increase fluid intake to help reduce kidney stone formation.
However, limited research has assessed the efficacy of this technology on improving fluid intake in college students.
College is a time with the potential to form healthy habits that carry into adulthood.
Previous work has also identified daily changes in morning urine color, thirst perception, and body mass, as simple, inexpensive indicators of daily fluctuations in water balance.
Tracking changes in these metrics has the potential to provide participants with evidence of adequate or inadequate fluid consumption.
Thus, the combination of prompting from a smart water bottle, as well as daily self-monitoring changes in hydration status, may encourage college students to increase daily fluid consumption.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mitchell E Zaplatosch, PhD
- Phone Number: 4705787600
- Email: mzaplato@kennesaw.edu
Study Locations
-
-
Georgia
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Kennesaw, Georgia, United States, 30144
- Recruiting
- Kennesaw State University
-
Contact:
- Mitchell Zaplatosch, PhD
- Email: mzaplato@kennesaw.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Participants must report currently drinking less than the European Food Safety Authority Recommendations for fluid, as determined by an online pre-screening survey (<2.5 L per day for males; <2.0 L per day for females).
- Has access to a cell phone which can download the app associated with the Smart Water Bottle.
Exclusion Criteria:
- Currently trying to gain or lose weight
- Have had surgery of the digestive tract
- Currently taking diuretics (e.g., Thiazide, Loop diuretics or potassium-sparing diuretics)
- Currently taking centrally-acting medications (e.g., anesthetics, anticonvulsants, central nervous system stimulants/amphetamines, muscle relaxants)
- Report currently consuming at least the European Food Safety Authority Recommendations for fluid, as determined by an online pre-screening survey (>= 2.5 L per day for males, >=2.0 L per day for females).
- Currently pregnant (females)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Smart Water Bottle
Participants in the intervention group will be prompted by the water bottle to drink (bottle will light up red) whenever they are behind on fluid intake recommendations for the day.
The bottle will be linked to a smart phone application that participants will be instructed to download on their personal mobile device, but they will log into this device using a researcher provided username and password.
The bottle will encourage male participants to consume 2.5 L and for female participants to consume 2.0 L of fluid.
Participants will be asked to use this bottle to consume all water and enter any additional sources of fluid using the mobile application.
The intervention group will also be asked to record their daily perceived thirst, first morning urine color, and body mass as a means of self-monitoring daily changes in hydration status, using a provided paper log.
|
Participants in the intervention group will receive a bottle which measures participant fluid consumption.
The bottle will be set to recommend 2.5L for male participants and 2.0L for female participants, consistent with fluid intake recommendations from the European Food Safety Authority for each sex.
Participants will be prompted by the bottle (bottle will light up) when they are behind on fluid intake recommendations.
Participants will use a validated urine color chart, 9 point Likert scale for thirst, and measure nude body mass on their own each morning.
Participants will be informed that higher values for nude body mass and thirst, and lower values for nude body mass each morning may indicate they are less hydrated day-to-day.
|
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No Intervention: Control
The control group will be asked to go about daily activities as normal.
They will not receive the water bottle and will not be asked to track daily measures of thirst, morning urine color, or body mass.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Fluid Intake
Time Frame: Pre and Post 2-week intervention
|
Total Fluid Intake will be reported by participants for 3 days before and after the intervention using a validated fluid log.
The average of 3-days of fluid recording will be used.
|
Pre and Post 2-week intervention
|
|
Changes in 24h urine osmolality
Time Frame: Pre and Post 2-week intervention
|
Urinary osmolality reflects the concentration of urine, with higher values indicative of worse hydration.
Urine osmolality will be collected for 3 days at the start and end of the study, with the average of each 3 day period used for analyses.
|
Pre and Post 2-week intervention
|
|
Changes in 24h urine volume
Time Frame: Pre and Post 2-week intervention
|
Higher urine volume tends to correspond with greater fluid intake.
|
Pre and Post 2-week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in urine color measured by validated urine color chart
Time Frame: Pre and Post 2-week intervention
|
A validated urine color will be used to rate urine samples.
Higher values correspond with worse hydration.
|
Pre and Post 2-week intervention
|
|
Changes in calorie intake from dietary log.
Time Frame: Pre and Post 2-week intervention
|
The ASA-24 is an electronic diet log participants will use to record their diet at the start and end of the study.
|
Pre and Post 2-week intervention
|
|
Change in copeptin
Time Frame: Pre and Post 2-week intervention
|
Copeptin is a surrogate marker for vasopressin, a major fluid regulatory hormone which increases fluid conservation at the kidneys.
|
Pre and Post 2-week intervention
|
|
Change in urine specific gravity
Time Frame: Pre and Post 2-week intervention
|
Measures the density of the urine.
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Pre and Post 2-week intervention
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Change in body water distribution
Time Frame: Pre and Post 2-week intervention
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Intracellular and extracellular water content measured via BIA.
|
Pre and Post 2-week intervention
|
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Change in Aldosterone
Time Frame: Pre and Post 2-week intervention
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Fluid regulatory hormone involved in plasma volume regulation.
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Pre and Post 2-week intervention
|
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Hydration KAB Scales
Time Frame: Pre and Post 2-week intervention.
|
Brief questionnaire assessing hydration knowledge, attitudes, and beliefs about hydration and fluid intake behaviors.
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Pre and Post 2-week intervention.
|
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Change in body fat percentage
Time Frame: Pre and Post 2-week intervention
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Assessed via dual-energy X-ray absorptiometry
|
Pre and Post 2-week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2024
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
February 7, 2024
First Submitted That Met QC Criteria
February 7, 2024
First Posted (Actual)
February 14, 2024
Study Record Updates
Last Update Posted (Estimated)
September 2, 2025
Last Update Submitted That Met QC Criteria
August 25, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Endocrine System Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Metabolic Diseases
- Water-Electrolyte Imbalance
- Pituitary Diseases
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Dehydration
- Diabetes Insipidus
Other Study ID Numbers
- MZ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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