Efficacy of a Smart Water Bottle Intervention to Increase Fluid Consumption in College Students

Dehydration Clinical Trial

Official title:

Efficacy of a Smart Water Bottle Intervention to Increase Fluid Consumption in College Students

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06259799
• Other study ID #: MZ
• Status: Recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Kennesaw State University
• Contact: Mitchell E Zaplatosch, PhD
• Phone: 4705787600
• Email: mzaplato[@]kennesaw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. "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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dehydration

Intervention

Behavioral:
• Smart Water Bottle
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.

Locations

Country	Name	City	State
United States	Kennesaw State University	Kennesaw	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Kennesaw State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Changes in 24h urine volume	Higher urine volume tends to correspond with greater fluid intake.	Pre and Post 2-week intervention
Secondary	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.	Pre and Post 2-week intervention
Secondary	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.	Pre and Post 2-week intervention
Secondary	Change in copeptin	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
Secondary	Change in urine specific gravity	Measures the density of the urine.	Pre and Post 2-week intervention
Secondary	Change in body water distribution	Intracellular and extracellular water content measured via BIA.	Pre and Post 2-week intervention
Secondary	Change in Aldosterone	Fluid regulatory hormone involved in plasma volume regulation.	Pre and Post 2-week intervention
Secondary	Hydration KAB Scales	Brief questionnaire assessing hydration knowledge, attitudes, and beliefs about hydration and fluid intake behaviors.	Pre and Post 2-week intervention.
Secondary	Change in body fat percentage	Assessed via dual-energy X-ray absorptiometry	Pre and Post 2-week intervention