Healthy Hydration Pilot in Elementary Schools

October 28, 2025 updated by: Virginia Commonwealth University

Addressing Root Causes of Under-hydration in School: A Stakeholder Collaborative Pilot Study

This study will pilot a school-based stakeholder-informed hydration intervention and examine its feasibility and preliminary efficacy.

Study Overview

Detailed Description

Adequate water intake plays an important role in maintaining children's overall health, cognitive performance, fine motor skills and visual attention. It also plays a role in the maintenance of healthy weight. Many children do not consume sufficient water, especially in school. There is also potential that by providing enhanced access to water, there will be corresponding decreases in sugary beverage intake. Sugary beverages have been implicated as major contributors of excessive sugar and calorie intake in children, leading to multiple health concerns, such as type 2 diabetes, overweight and obesity, and dental caries. Schools are an optimal environment to increase children's water intake. Healthy hydration is a priority for Richmond Public School (RPS), as they recently adopted a new hydration policy into their school wellness policy, with hydration stations installed in all RPS schools. The purpose of this study is to determine the feasibility of a school-based hydration intervention. This study will pilot a school-based stakeholder-informed hydration intervention and examine its feasibility and preliminary efficacy.

Study Type

Interventional

Enrollment (Actual)

563

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 Locations

    • Virginia
      • Richmond, Virginia, United States, 23235
        • Virginia Commonwealth University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion:

  • Lunchroom observations: All students (K-5th) who eat lunch in the cafeteria on assessment days are eligible for lunchroom observations (observing what beverages are selected and presence of water bottles)
  • BMI and dental caries assessments: 1) student is in the 3rd grade; 2) English or Spanish speaking.
  • Student surveys: Students in 4th-5th grade are eligible to complete surveys assessing beverage intake and perceptions of hydration practices in their district.
  • Staff surveys: All staff in the target schools will be eligible to complete the School Environment Survey.

Exclusion:

  • Lunchroom observations: None.
  • BMI and dental caries assessments: Students are ineligible if they: 1) are non-English or non-Spanish speaking; 2) have a medical condition that precludes drinking water or that can put them at risk for failure to thrive or poor weight gain, 2) are unable to complete assessments due to developmental delays, 3) plan to move from the school district during the study period.
  • Student surveys: Students in 4th-5th grade who are unable to complete surveys due to developmental delays will be ineligible.
  • Staff surveys: None.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydration Intervention
Students and staff at the intervention school will receive a school-based hydration intervention that includes a student-developed marketing campaign and incentivizes water bottles in school.

Teacher & student ambassadors: serve as hydration role models, identify "Hydration Heroes", monitor filter lights on hydration stations, & update the water meter visual.

Kick-off event: event to kick off the hydration intervention to include water bottles distribution with a station to personalize, experiential activities, and information about the intervention.

Social marketing: student-developed marketing campaign "Make water your superpower" will be placed in high-traffic areas of the school. Hydration Headquarters will be located in the lunchroom displaying a water meter illustrating bottle refills from the school's hydration stations.

Behavioral reinforcement: on random days, students drinking water and/or with a water bottle will receive small incentives.

Education and outreach: Hydration Tip Sheets, hydration signage in classrooms, and hydration trivia on hydration stations. Teachers will deliver 1 hydration lesson per month that align with Standards of Learning.

Placebo Comparator: Control
Students and staff at the control school will participate in assessments only.
Assessments only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment of Three 4th or 5th Grade Student Students to Assume the Role as Student Ambassador.
Time Frame: 1 month (pre-intervention to baseline)
Ability to recruit the required number of 4th or 5th grade student ambassadors at the intervention school at start of trial.
1 month (pre-intervention to baseline)
Retention of 3 Student Ambassadors
Time Frame: 4 months
Percentage of student ambassadors who continued participation in their role throughout the intervention period (intervention group only).
4 months
Number of School Personnel Participants Who Reported Being Satisfied With the Intervention
Time Frame: Post (month 4)
The percent of personnel in the intervention group who agreed or strongly agreed with being satisfied with the intervention (intervention group only). Measured via surveys.
Post (month 4)
Implementation of Intervention Activities.
Time Frame: 4 months
Percentage of intervention activities conducted per protocol
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index
Time Frame: Baseline and post (month 4)
NHANES Anthropometry methods used to measure height and weight
Baseline and post (month 4)
Water Bottle Usage
Time Frame: Baseline, mid point 1 (month 2), mid point 2 (month 3), post (month 4)
% of students with water bottles in school
Baseline, mid point 1 (month 2), mid point 2 (month 3), post (month 4)
Hydration Station Usage
Time Frame: Baseline & post (4 month)
Ounces of water used per student per day over 4 months measured by hydration station flow meters. Flow meters captured all water usage in all hydration stations over the 4-month trial. Values were collected from the flow meters at baseline and post (4 months).
Baseline & post (4 month)
Sugar-sweetened Beverages at Lunch
Time Frame: Baseline, midpoint 1 (month 1), midpoint 2 (month 2), post (month 4)
% of students with sugar-sweetened beverages at lunch
Baseline, midpoint 1 (month 1), midpoint 2 (month 2), post (month 4)
Dental Caries Status - Teeth
Time Frame: Baseline and post (month 4)
measured by a modified International Caries Detection and Assessment System (ICDAS) using the DMFT (decayed, missing, and filled permanent teeth)/dmft (decayed, missing, and filled primary teeth) index. DMFT/dmft was defined as the total number of teeth with at least one decayed, missing, or filled tooth surface, with higher scores indicating worse dental health. Possible DMFT (permanent teeth) ranges are 0 to 28. Possible dmft (primary or baby teeth) ranges are 0 to 20.
Baseline and post (month 4)
Dental Caries Status - Teeth Surfaces
Time Frame: Baseline and post (month 4)
measured by a modified International Caries Detection and Assessment System (ICDAS) using the DMFS (decayed, missing, and filled permanent surfaces)/dmfs (decayed, missing, and filled primary surfaces) index. DMFS/dmfs was defined as the total number of tooth surfaces with decay, fillings, or that were missing due to decay, with higher scores indicating worse dental health. Possible DMFS ranges are 0 to 128 surfaces, as molars and premolars have 5 surfaces and incisors and canines have 4 surfaces, while for baby teeth, possible dmfs ranges from 0-88 surfaces.
Baseline and post (month 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Melanie Bean, Virginia Commonwealth University

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)

November 9, 2023

Primary Completion (Actual)

April 22, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Estimated)

October 31, 2025

Last Update Submitted That Met QC Criteria

October 28, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • HM20023592

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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