NCT06259799

Brief 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. "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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

1.7 years

First QC Date

February 7, 2024

Last Update Submit

August 25, 2025

Conditions

Keywords

underhydrationcopeptinurinewater

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    Pre and Post 2-week intervention

  • Changes in 24h urine volume

    Higher urine volume tends to correspond with greater fluid intake.

    Pre and Post 2-week intervention

Secondary Outcomes (8)

  • Change in urine color measured by validated urine color chart

    Pre and Post 2-week intervention

  • Changes in calorie intake from dietary log.

    Pre and Post 2-week intervention

  • Change in copeptin

    Pre and Post 2-week intervention

  • Change in urine specific gravity

    Pre and Post 2-week intervention

  • Change in body water distribution

    Pre and Post 2-week intervention

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Smart Water Bottle

Eligibility Criteria

Age18 Years - 35 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennesaw State University

Kennesaw, Georgia, 30144, United States

RECRUITING

MeSH Terms

Conditions

DehydrationDiabetes Insipidus

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Central Study Contacts

Mitchell E Zaplatosch, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 14, 2024

Study Start

April 1, 2024

Primary Completion

December 1, 2025

Study Completion

April 1, 2026

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations