Advancing Water Security: A Community Participatory School-Based Hydration Intervention

June 8, 2026 updated by: Virginia Commonwealth University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Henrico, Virginia, United States, 23229
        • Recruiting
        • Children's Hospital of Richmond at VCU Healthy Lifestyles Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Melanie K Bean, PhD
        • Principal Investigator:
          • Tegwyn H Brickhouse, DDS

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Assessment only
Experimental: Hydration Intervention
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.
Behavioral: Hydration
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Water Station Usage
Time Frame: Years 1-3
Ounces of water per student per day measured by hydration station flow meters.
Years 1-3
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)
up to 3 years
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
up to 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Water Bottle Usage at Lunch
Time Frame: up to 3 years
% of students with water bottles in school
up to 3 years
Beverage Selection at Lunch
Time Frame: up to 3 years
% of each beverage selected (water, white milk, flavored milk, 100% juice, soda, sports-drink, other sugar-sweetened beverage (SSB), other non-SSB, unknown)
up to 3 years
Water Source Assessment
Time Frame: up to 3 years
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
up to 3 years
School Personnel Knowledge
Time Frame: up to 3 years
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
up to 3 years
School Environment
Time Frame: up to 3 years
Measured via semi-structured interview: assessing water and SSB-related access, policies and practices in their school
up to 3 years
Beverage Sales
Time Frame: up to 3 years
We will evaluate purchases of white milk, sugar-sweetened milk, 100% juice, and other beverages.
up to 3 years
Academics
Time Frame: up to 3 years
Standards of Learning scores ranging from 0-600 with higher scores representing higher academic proficiency.
up to 3 years
Beverage Intake
Time Frame: up to 3 years
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.
up to 3 years
National School Lunch Program (NSLP) Participation
Time Frame: up to 3 years
Daily and monthly NSLP participation rates will be obtained
up to 3 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: up to 3 years
School-level sex, race, ethnicity and enrollment will be obtained from the Department of Education
up to 3 years
Attendance
Time Frame: Pre-intervention, Month 1, Month 2, Month 3
Attendance by grade on observation days will be obtained (to determine participation rates)
Pre-intervention, Month 1, Month 2, Month 3
Implementation of Intervention
Time Frame: through study completion, an average of each year
Fidelity checklists, surveys, logs of implementation components
through study completion, an average of each year
Perspectives of the intervention
Time Frame: 4 months and 16 months post-intervention
Semi-structured interviews with key stakeholders to assess barriers and facilitators to intervention implementation and sustainability.
4 months and 16 months post-intervention

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HM20028646
  • R01HD114792 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Final submission and release of the study data will occur no later than the time of an associated publication or end of the performance period, whichever comes first. Study data deposited in DASH are available to the research community in perpetuity.

IPD Sharing Access Criteria

Public Use Data: All deidentified study data will be made available as public use data to the research community via DASH. Sharing will occur in accordance with the participant consent and Virginia Commonwealth University (VCU) Institutional Review Board approval. Users of the public use data must register with DASH and agree to the Terms of Use, which are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, and requiring immediate reporting of any disclosure of study participant identity. Data users also agree not to share or redistribute any data downloads. Datasets in DASH will be findable and identifiable through a study digital object identifier (DOI) assigned by DASH.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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