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

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: Recruiting
• Conditions: Dental Caries; Obesity Prevention
• Intervention / Treatment: Behavioral: Hydration

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: Interventional
• Enrollment (Estimated): 7200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melanie K Bean, PhD; Phone Number: 804-527-4765; Email: melanie.bean@vcuhealth.org
• Study Contact Backup: Name: Sarah Farthing, MS; Phone Number: 804-527-4756; Email: sarah.malone@vcuhealth.org

Study Locations

• United States
  • Virginia
    • Henrico, Virginia, United States, 23229
      • Recruiting
      • Children's Hospital of Richmond at VCU Healthy Lifestyles Center
      • Contact: Melanie K Bean, PhD; Phone Number: (804) 527-4765; Email: melanie.bean@vcuhealth.org
      • Contact: Sarah M Farthing, MS; Phone Number: 804-527-4756; Email: sarah.malone@vcuhealth.org
      • Principal Investigator: Melanie K Bean, PhD
      • Principal Investigator: Tegwyn H Brickhouse, DDS

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Water Station Usage	Ounces of water per student per day measured by hydration station flow meters.	Years 1-3
Dental Caries Status	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)	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

Outcome Measure	Measure Description	Time Frame
Water Bottle Usage at Lunch	% of students with water bottles in school	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)	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	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	up to 3 years
School Environment	Measured via semi-structured interview: assessing water and SSB-related access, policies and practices in their school	up to 3 years
Beverage Sales	We will evaluate purchases of white milk, sugar-sweetened milk, 100% juice, and other beverages.	up to 3 years
Academics	Standards of Learning scores ranging from 0-600 with higher scores representing higher academic proficiency.	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.	up to 3 years
National School Lunch Program (NSLP) Participation	Daily and monthly NSLP participation rates will be obtained	up to 3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	School-level sex, race, ethnicity and enrollment will be obtained from the Department of Education	up to 3 years
Attendance	Attendance by grade on observation days will be obtained (to determine participation rates)	Pre-intervention, Month 1, Month 2, Month 3
Implementation of Intervention	Fidelity checklists, surveys, logs of implementation components	through study completion, an average of each year
Perspectives of the 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

• Sponsor: Virginia Commonwealth University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: November 10, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: sugar-sweetened beverages; water; dental caries; overweight and obesity; hydration
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID 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