HydrationNCT06132763
Healthy Hydration Pilot in Elementary Schools
A study testing Hydration Intervention in people with Hydration and Dental Caries, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study will pilot a school-based stakeholder-informed hydration intervention and examine its feasibility and preliminary efficacy. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hydration, Dental Caries, Body Mass Index
- What is being tested?
- Hydration Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 563 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23235
About this study
Official title: 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.
Read the 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.
- Conditions
- Hydration, Dental Caries, Body Mass Index
- Being tested
- Hydration Intervention, Control - Assessments Only
- Keywords
- Hydration, Water bottle, Sugary Beverages
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydration InterventionBehavioural
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.
Control - Assessments OnlyOther
Assessments only
| Study group | Role | What they receive |
|---|---|---|
| Hydration Intervention | Experimental | 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. Receives: Behavioral: Hydration Intervention |
| Control | Placebo comparator | Students and staff at the control school will participate in assessments only. Receives: Other: Control - Assessments Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment of Three 4th or 5th Grade Student Students to Assume the Role as Student Ambassador.
Ability to recruit the required number of 4th or 5th grade student ambassadors at the intervention school at start of trial.
Measured: 1 month (pre-intervention to baseline)
Retention of 3 Student Ambassadors
Percentage of student ambassadors who continued participation in their role throughout the intervention period (intervention group only).
Measured: 4 months
Number of School Personnel Participants Who Reported Being Satisfied With the Intervention
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.
Measured: Post (month 4)
Implementation of Intervention Activities.
Percentage of intervention activities conducted per protocol
Measured: 4 months
Secondary outcomes (6)
Water Bottle Usage
% of students with water bottles in school
Measured: Baseline, mid point 1 (month 2), mid point 2 (month 3), post (month 4)
Hydration Station Usage
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).
Measured: Baseline & post (4 month)
Sugar-sweetened Beverages at Lunch
% of students with sugar-sweetened beverages at lunch
Measured: Baseline, midpoint 1 (month 1), midpoint 2 (month 2), post (month 4)
Dental Caries Status - Teeth
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.
Measured: Baseline and post (month 4)
Dental Caries Status - Teeth Surfaces
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.
Measured: Baseline and post (month 4)
Body Mass Index
NHANES Anthropometry methods used to measure height and weight
Measured: Baseline and post (month 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start9 Nov 2023
- Primary completion22 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HydrationStudies 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
- None (open label)
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Bean, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132763
- Sponsor's protocol ID
- HM20023592
- Status last verified
- Oct 2025
- First submitted
- 31 Oct 2023
- Last updated
- 31 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Root Causes of Under-hydration in School: A Stakeholder Collaborative Pilot Study
- ClinicalTrials.gov ID
- NCT06132763
- Acronym / sponsor ID
- HM20023592
- Conditions
- Hydration, Dental Caries, Body Mass Index
- Keywords
- Hydration, Water bottle, Sugary Beverages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will pilot a school-based stakeholder-informed hydration intervention and examine its feasibility and preliminary efficacy.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydration Intervention | Experimental | Behavioral: Hydration InterventionStudents 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. |
| Control | Placebo comparator | Other: Control - Assessments OnlyStudents and staff at the control school will participate in assessments only. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Hydration InterventionTeacher \& 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. | Behavioural | Hydration Intervention |
| Control - Assessments OnlyAssessments only | Other | Control |
Primary outcome
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.
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).
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.
Implementation of Intervention Activities.
Time frame: 4 months
Percentage of intervention activities conducted per protocol
6 secondary outcomes
Water Bottle Usage
Time frame: Baseline, mid point 1 (month 2), mid point 2 (month 3), post (month 4)
Hydration Station Usage
Time frame: Baseline & post (4 month)
Sugar-sweetened Beverages at Lunch
Time frame: Baseline, midpoint 1 (month 1), midpoint 2 (month 2), post (month 4)
Dental Caries Status - Teeth
Time frame: Baseline and post (month 4)
Dental Caries Status - Teeth Surfaces
Time frame: Baseline and post (month 4)
Body Mass Index
Time frame: Baseline and post (month 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Melanie Bean principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydration Intervention in people with Hydration and Dental Caries, run by Virginia Commonwealth 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 4 inclusion and 4 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 31 Oct 2025. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recruitment of Three 4th or 5th Grade Student Students to Assume the Role as Student Ambassador. (time frame: 1 month (pre-intervention to baseline)). The study lists 4 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 31 Oct 2025; AzTrials last refreshed its copy on 28 Oct 2026.