Dental CariesNCT06714929
Advancing Water Security: A Community Participatory School-Based Hydration Intervention
A study testing Hydration in people with Dental Caries and Obesity Prevention, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The goal of this study is to determine the effectiveness and sustainability of a community-participatory hydration intervention over 3 years within a district that has newly installed hydration stations and is operating under a policy designed to enhance heathy hydration practices and promote equitable access to… Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Obesity Prevention
- What is being tested?
- Hydration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 [Pre-Kindergarten if applicable]) who eat lunch in the cafeteria on assessment days are eligible
- BMI and dental caries assessments: 1) student enrolls in study while in 3rd grade (followed through 5th g)
- Student surveys: Students in 4th-5th grade are eligible to complete surveys assessing beverage intake and perceptions of hydration practices within their school district.
- Staff surveys: All staff in the target schools will be eligible to complete the Personnel Survey.
Who cannot join
- Lunchroom observations: None.
- BMI and dental caries assessments: Students are ineligible if they are unable to complete assessments due to developmental or physical reasons, 2) planning to move in the study duration
- Student surveys: None.
- Staff surveys: None.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Richmond at VCU Healthy Lifestyles Center
Henrico, Virginia, 23229
Sarah M Farthing, MS, 804-527-4756, sarah.malone@vcuhealth.org
Melanie K Bean, PhD, (804) 527-4765, melanie.bean@vcuhealth.org
About this study
The goal of this study is to determine the effectiveness and sustainability of a community-participatory hydration intervention over 3 years within a district that has newly installed hydration stations and is operating under a policy designed to enhance heathy hydration practices and promote equitable access to drinking water.
Read the detailed description
The goal of this study is to determine the effectiveness of a hydration intervention on hydration station usage (primary outcome), Body Mass Index z-scores (zBMI) and dental caries (primary biomedical outcomes), and water bottle usage, beverage selection and intake, and academic outcomes (secondary outcomes).
- Conditions
- Dental Caries, Obesity Prevention
- Being tested
- Hydration
- Keywords
- hydration, water, sugar-sweetened beverages, dental caries, overweight and obesity
- Medical subject headings
- Dental Caries, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrationBehavioural
Clusters of schools will sequentially be exposed to the intervention in a stepped-wedge fashion. The intervention is a 4-month community participatory school-based hydration intervention that includes provision of refillable water bottles in schools with hydration stations in addition to: 1) social marketing, 2) behavioral reinforcement, and 3) education and outreach.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Assessment only |
| Hydration Intervention | Experimental | 4-month community participatory school-based hydration intervention that includes provision of refillable water bottles in schools with hydration stations in addition to: 1) social marketing, 2) behavioral reinforcement, and 3) education and outreach. Receives: Behavioral: Hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Water Station Usage
Ounces of water per student per day measured by hydration station flow meters.
Measured: Years 1-3
Dental Caries Status
Tooth decay or cavities will be measured using a modified International Caries Detection and Assessment System (ICDAS)
Measured: up to 3 years
Body Mass Index (BMI)
NHANES Anthropometry methods used to measure height and weight. Age and sex-specific BMIz-score and BMI percentile will be calculated using Epi Info
Measured: up to 3 years
Secondary outcomes (9)
Water Bottle Usage at Lunch
% of students with water bottles in school
Measured: up to 3 years
Beverage Selection at Lunch
% of each beverage selected (water, white milk, flavored milk, 100% juice, soda, sports-drink, other sugar-sweetened beverage (SSB), other non-SSB, unknown)
Measured: up to 3 years
Academics
Standards of Learning scores ranging from 0-600 with higher scores representing higher academic proficiency.
Measured: up to 3 years
Beverage Intake
modified beverage intake questionnaire (BEVQ; 12-item) will assess frequency and amount of SSB and water consumption to determine average daily consumption in fl oz and kcal over the past month for each item and across categories: water, total SSBs (sweetened juice and drinks, regular carbonated beverages, sweet tea, sweetened coffee, energy drinks), milk, 100% juice.
Measured: up to 3 years
Water Source Assessment
Video of water sources and then coded by trained raters. Coding for: cleanliness, wear, availability of drinking vessels, filter status, obstructions, signage, trash, and water flow
Measured: up to 3 years
School Personnel Knowledge
Measured via surveys: perceptions of water bottle use and hydration in school, knowledge and beliefs about hydration, personnel hydration practices, and awareness of and adherence to existing hydration policy
Measured: up to 3 years
School Environment
Measured via semi-structured interview: assessing water and SSB-related access, policies and practices in their school
Measured: up to 3 years
Beverage Sales
We will evaluate purchases of white milk, sugar-sweetened milk, 100% juice, and other beverages.
Measured: up to 3 years
National School Lunch Program (NSLP) Participation
Daily and monthly NSLP participation rates will be obtained
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start14 Aug 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Sequential
- Model description
- Stepped wedge cluster randomized controlled trial; 4 groups of schools sequentially receive the intervention each year over 3 years. Assessments of all 12 schools occur at all timepoints over the 3 years.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 7,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714929
- Sponsor's protocol ID
- HM20028646
- Other IDs
- R01HD114792
- Status last verified
- Jun 2026
- First submitted
- 10 Nov 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following research data will be generated from this study: 1) lunchroom observations (beverage selection and water bottle use); 2) cafeteria sales data; 3) hydration station usage; 4) academic data (Standards of Learning scores, attendance); and 4) survey data. Student survey data include demographics, beverage intake, and intervention perceptions. Staff survey data includes hydration policies and practices and intervention perceptions. Longitudinal assessments of anthropometrics (serial height and weight measurements) and dental caries will be available from a subset of students (n=406). A subset of individuals will also complete interviews (n=80) regarding intervention implementation and sustainability. Any potentially identifying information (e.g., of individuals, schools, or the district) will be removed from these data prior to uploading them to the NICHD Data and Specimen Hub.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Water Security: A Community Participatory School-Based Hydration Intervention
- ClinicalTrials.gov ID
- NCT06714929
- Acronym / sponsor ID
- HM20028646
- Conditions
- Dental Caries, Obesity Prevention
- Keywords
- hydration, water, sugar-sweetened beverages, dental caries, overweight and obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7,200 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine the effectiveness and sustainability of a community-participatory hydration intervention over 3 years within a district that has newly installed hydration stations and is operating under a policy designed to enhance heathy hydration practices and promote equitable access to drinking water.
Detailed description
The goal of this study is to determine the effectiveness of a hydration intervention on hydration station usage (primary outcome), Body Mass Index z-scores (zBMI) and dental caries (primary biomedical outcomes), and water bottle usage, beverage selection and intake, and academic outcomes (secondary outcomes).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped wedge cluster randomized controlled trial; 4 groups of schools sequentially receive the intervention each year over 3 years. Assessments of all 12 schools occur at all timepoints over the 3 years.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Assessment only |
| Hydration Intervention | Experimental | Behavioral: Hydration4-month community participatory school-based hydration intervention that includes provision of refillable water bottles in schools with hydration stations in addition to: 1) social marketing, 2) behavioral reinforcement, and 3) education and outreach. |
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 [Pre-Kindergarten if applicable]) who eat lunch in the cafeteria on assessment days are eligible
- BMI and dental caries assessments: 1) student enrolls in study while in 3rd grade (followed through 5th g)
- Student surveys: Students in 4th-5th grade are eligible to complete surveys assessing beverage intake and perceptions of hydration practices within their school district.
- Staff surveys: All staff in the target schools will be eligible to complete the Personnel Survey.
Key exclusion criteria (4 listed)
- Lunchroom observations: None.
- BMI and dental caries assessments: Students are ineligible if they are unable to complete assessments due to developmental or physical reasons, 2) planning to move in the study duration
- Student surveys: None.
- 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 |
|---|---|---|
| HydrationClusters of schools will sequentially be exposed to the intervention in a stepped-wedge fashion. The intervention is a 4-month community participatory school-based hydration intervention that includes provision of refillable water bottles in schools with hydration stations in addition to: 1) social marketing, 2) behavioral reinforcement, and 3) education and outreach. | Behavioural | Hydration Intervention |
Primary outcome
Water Station Usage
Time frame: Years 1-3
Ounces of water per student per day measured by hydration station flow meters.
Dental Caries Status
Time frame: up to 3 years
Tooth decay or cavities will be measured using a modified International Caries Detection and Assessment System (ICDAS)
Body Mass Index (BMI)
Time frame: up to 3 years
NHANES Anthropometry methods used to measure height and weight. Age and sex-specific BMIz-score and BMI percentile will be calculated using Epi Info
9 secondary outcomes
Water Bottle Usage at Lunch
Time frame: up to 3 years
Beverage Selection at Lunch
Time frame: up to 3 years
Academics
Time frame: up to 3 years
Beverage Intake
Time frame: up to 3 years
Water Source Assessment
Time frame: up to 3 years
School Personnel Knowledge
Time frame: up to 3 years
School Environment
Time frame: up to 3 years
Beverage Sales
Time frame: up to 3 years
National School Lunch Program (NSLP) Participation
Time frame: up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes. The following research data will be generated from this study: 1) lunchroom observations (beverage selection and water bottle use); 2) cafeteria sales data; 3) hydration station usage; 4) academic data (Standards of Learning scores, attendance); and 4) survey data. Student survey data include demographics, beverage intake, and intervention perceptions. Staff survey data includes hydration policies and practices and intervention perceptions. Longitudinal assessments of anthropometrics (serial height and weight measurements) and dental caries will be available from a subset of students (n=406). A subset of individuals will also complete interviews (n=80) regarding intervention implementation and sustainability. Any potentially identifying information (e.g., of individuals, schools, or the district) will be removed from these data prior to uploading them to the NICHD Data and Specimen Hub.
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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.
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 in people with Dental Caries and Obesity Prevention, 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Farthing, MS (804-527-4756, sarah.malone@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Water Station Usage (time frame: Years 1-3). The study lists 3 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 10 Jun 2026.