DehydrationNCT06259799
Efficacy of a Smart Water Bottle Intervention to Increase Fluid Consumption in College Students
A study testing Smart Water Bottle in people with Dehydration, run by Kennesaw State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Smart Water Bottle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 16 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dehydration
- Being tested
- Smart Water Bottle
- Keywords
- underhydration, copeptin, urine, water
- Medical subject headings
- Dehydration, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Water BottleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Smart Water Bottle | Experimental | 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. Receives: Behavioral: Smart Water Bottle |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Fluid Intake
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.
Measured: Pre and Post 2-week intervention
Changes in 24h urine osmolality
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.
Measured: Pre and Post 2-week intervention
Changes in 24h urine volume
Higher urine volume tends to correspond with greater fluid intake.
Measured: Pre and Post 2-week intervention
Secondary outcomes (8)
Change in urine color measured by validated urine color chart
A validated urine color will be used to rate urine samples. Higher values correspond with worse hydration.
Measured: Pre and Post 2-week intervention
Changes in calorie intake from dietary log.
The ASA-24 is an electronic diet log participants will use to record their diet at the start and end of the study.
Measured: Pre and Post 2-week intervention
Change in copeptin
Copeptin is a surrogate marker for vasopressin, a major fluid regulatory hormone which increases fluid conservation at the kidneys.
Measured: Pre and Post 2-week intervention
Change in urine specific gravity
Measures the density of the urine.
Measured: Pre and Post 2-week intervention
Change in body water distribution
Intracellular and extracellular water content measured via BIA.
Measured: Pre and Post 2-week intervention
Change in Aldosterone
Fluid regulatory hormone involved in plasma volume regulation.
Measured: Pre and Post 2-week intervention
Hydration KAB Scales
Brief questionnaire assessing hydration knowledge, attitudes, and beliefs about hydration and fluid intake behaviors.
Measured: Pre and Post 2-week intervention.
Change in body fat percentage
Assessed via dual-energy X-ray absorptiometry
Measured: Pre and Post 2-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Apr 2024
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kennesaw State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259799
- Sponsor's protocol ID
- MZ
- Status last verified
- Aug 2025
- First submitted
- 7 Feb 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Smart Water Bottle Intervention to Increase Fluid Consumption in College Students
- ClinicalTrials.gov ID
- NCT06259799
- Acronym / sponsor ID
- MZ
- Conditions
- Dehydration
- Keywords
- underhydration, copeptin, urine, water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kennesaw State UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart Water Bottle | Experimental | Behavioral: Smart Water BottleParticipants 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Water BottleParticipants 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. | Behavioural | Smart Water Bottle |
Primary outcome
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.
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.
Changes in 24h urine volume
Time frame: Pre and Post 2-week intervention
Higher urine volume tends to correspond with greater fluid intake.
8 secondary outcomes
Change in urine color measured by validated urine color chart
Time frame: Pre and Post 2-week intervention
Changes in calorie intake from dietary log.
Time frame: Pre and Post 2-week intervention
Change in copeptin
Time frame: Pre and Post 2-week intervention
Change in urine specific gravity
Time frame: Pre and Post 2-week intervention
Change in body water distribution
Time frame: Pre and Post 2-week intervention
Change in Aldosterone
Time frame: Pre and Post 2-week intervention
Hydration KAB Scales
Time frame: Pre and Post 2-week intervention.
Change in body fat percentage
Time frame: Pre and Post 2-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Hydration & Female Life Stages
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Water Bottle in people with Dehydration, run by Kennesaw State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Fluid Intake (time frame: Pre and Post 2-week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.