Smart Water Bottle for Dehydration

Overseen By Mitchell E Zaplatosch, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kennesaw State University

Must not be taking: Diuretics, Centrally-acting medications

Disqualifiers: Weight change, Digestive surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are currently taking diuretics (medications that help remove excess water from the body) or centrally-acting medications (medications that affect the brain and nervous system), you cannot participate in this trial.

What data supports the effectiveness of the treatment Smart Water Bottle for dehydration?

The research indicates that smart water bottles, like the HidrateSpark, can accurately monitor fluid intake, which is important for preventing dehydration. Although these bottles have not been validated in clinical trials, they show promise in helping people track their hydration levels effectively. ^{1 2 3 4 5}

Is the Smart Water Bottle safe for human use?

The available research does not provide specific safety data for smart water bottles, but they are generally used by health-conscious adults and athletes without reported safety issues. ^{1 6 7 8 9}

How does the Smart Water Bottle treatment for dehydration differ from other treatments?

The Smart Water Bottle is unique because it uses advanced sensors to accurately monitor fluid intake and physiological parameters in real-time, providing personalized hydration management without the need for invasive methods. ^{1 4 7 10 11}

Eligibility Criteria

This trial is for college students who drink less fluid than recommended (<2.5L/day for males, <2.0L/day for females) and have a cell phone compatible with the Smart Water Bottle app.

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

Currently pregnant (females)

I am currently taking medication that affects my brain or nervous system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants in the intervention group use a smart water bottle to track and increase fluid intake, while the control group continues normal activities without intervention.

2 weeks

1 visit (in-person) for initial setup

Follow-up

Participants are monitored for changes in fluid intake and hydration status after the intervention.

2 weeks

1 visit (in-person) for final assessment

Treatment Details

Interventions

• Smart Water Bottle

Trial Overview The study tests if using a 'Smart Water Bottle', which tracks intake and prompts drinking, can help college students meet daily fluid recommendations to form healthier hydration habits.

Participant Groups

Group I: Smart Water Bottle Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 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 Is Running the Clinical Trial?

Kennesaw State University

Lead Sponsor

Trials

14

Recruited

860+

Findings from Research

The study evaluated four smart bottles for monitoring fluid intake, finding that the H2OPal had the lowest Mean Percent Error (MPE), indicating it was the most accurate in tracking fluid consumption across multiple sips.

The HidrateSpark 3 was noted for its consistent and reliable performance, while the Thermos Smart Lid was the least accurate due to its sensor design, which missed many recordings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring fluid intake by commercially available smart water bottles. Cohen, R., Fernie, G., Roshan Fekr, A.[2022]

Hydration monitoring is crucial for vulnerable populations, such as young children and the elderly, who are at higher risk of dehydration and its negative effects.

Emerging technologies for monitoring hydration status show promise and require thorough evaluation to ensure their effectiveness and reliability for use outside clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Monitoring to Detect Dehydration: Are We There Yet? Gray, M., Birkenfeld, JS., Butterworth, I.[2023]

In a study involving 10 healthy male volunteers, participants effectively managed their own intravenous rehydration based on their thirst, demonstrating a strong correlation between thirst scores and plasma osmolality levels.

When given the option to control the volume of fluid, those in the high-volume condition rehydrated significantly more (3060 ml) compared to the low-volume condition (981 ml), suggesting that allowing patients to self-manage their hydration could improve clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thirst-guided participant-controlled intravenous fluid rehydration: a single blind, randomised crossover study. Lacey, J., Corbett, J., Shepherd, A., et al.[2020]

A new portable MR sensor can noninvasively measure fluid loss in skeletal muscle, providing a reliable way to detect dehydration without needing invasive procedures.

In tests with mice, the sensor accurately identified dehydration-induced fluid loss, showing strong agreement with traditional NMR methods, making it a promising tool for point-of-care dehydration monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dehydration assessment via a portable, single sided magnetic resonance sensor. Bashyam, A., Frangieh, CJ., Li, M., et al.[2021]

This study developed clinical diagnostic models to assess dehydration severity in over 2,100 patients with acute diarrhea, showing that these models are more reliable and accurate than the current WHO algorithm.

The full model achieved a high reliability score (0.90) and an accuracy of 0.79 for identifying severe dehydration, indicating that these new models could significantly enhance patient management in low-resource settings once validated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Derivation of the first clinical diagnostic models for dehydration severity in patients over five years with acute diarrhea. Levine, AC., Barry, MA., Gainey, M., et al.[2023]

The Soldier Water Estimation Tool (SWET) is an Android application designed to help military personnel accurately estimate their drinking water needs based on factors like activity level, clothing, temperature, and humidity, making water planning more efficient.

Preliminary testing showed that users found SWET easy to use and relevant, which could help reduce the risk of dehydration and improve overall health and performance during military operations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Planning Military Drinking Water Needs: Development of a User-Friendly Smart Device Application. Charkoudian, N., Kenefick, RW., Lapadula, AJ., et al.[2018]

A study involving 30 male American football athletes demonstrated that a smart bottle accurately measures fluid intake during exercise, with no significant difference compared to traditional gravimetric methods.

The smart bottle's measurements were reliable within approximately ±15% of individual fluid intake, making it a useful tool for athletes to track hydration in real-time during outdoor practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of a smart bottle in measuring fluid intake by American football players during pre-season training. Baker, LB., Alfred, S., Lee, KA., et al.[2023]

The hands-free drinking system, called the Hydrant, was tested in hospital wards and the community, showing potential to improve hydration and reduce infection risks for patients who cannot drink unaided.

While the Hydrant was beneficial for many patients, it was found to be less suitable for older individuals, particularly those undergoing rehabilitation, indicating a need for tailored hydration solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does hands-free drinking improve patient hydration? Sutton, D., Stroud, M.[2016]

In a study of 50 male infants aged 0-3 months, both a 2:1 rehydration regimen of WHO-ORS and diluted WHO-ORS were found to be equally safe and effective in correcting hydration status and serum sodium levels.

However, misinterpretation of rehydration instructions led to complications such as hypernatremia and irritability in some infants, highlighting the importance of clear guidance when administering rehydration solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral therapy of neonates and young infants with World Health Organization rehydration packets: a controlled trial of two sets of instructions. Bhargava, SK., Sachdev, HP., Das Gupta, B., et al.[2019]

The intelligent water bottle prototype can accurately measure liquid levels and monitor user activity and physiological parameters, showcasing its potential for personalized health monitoring.

Preliminary field testing of the smart water bottle indicates its effectiveness when integrated into a personal body sensor network or used as a cloud-based device, highlighting its versatility in eHealth applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SmartStuff: A case study of a smart water bottle. Jovanov, E., Nallathimmareddygari, VR., Pryor, JE.[2020]

A wearable body hydration sensor was tested on 240 participants during physical exercise, showing a strong correlation with standard medical balance measurements for tracking water loss due to perspiration.

The device demonstrated high accuracy, with an average error of about 2% and less than 5% of values falling outside the 95% confidence interval, indicating it could be a reliable tool for monitoring hydration in older adults and during physical training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An accurate wearable hydration sensor: Real-world evaluation of practical use. Rodin, D., Shapiro, Y., Pinhasov, A., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Monitoring fluid intake by commercially available smart water bottles. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Noninvasive Monitoring to Detect Dehydration: Are We There Yet? [2023]

3. England pubmed.ncbi.nlm.nih.gov

Thirst-guided participant-controlled intravenous fluid rehydration: a single blind, randomised crossover study. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Dehydration assessment via a portable, single sided magnetic resonance sensor. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Derivation of the first clinical diagnostic models for dehydration severity in patients over five years with acute diarrhea. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Planning Military Drinking Water Needs: Development of a User-Friendly Smart Device Application. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Accuracy of a smart bottle in measuring fluid intake by American football players during pre-season training. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Does hands-free drinking improve patient hydration? [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Oral therapy of neonates and young infants with World Health Organization rehydration packets: a controlled trial of two sets of instructions. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

SmartStuff: A case study of a smart water bottle. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

An accurate wearable hydration sensor: Real-world evaluation of practical use. [2022]