Recruiting

Hydration Intervention

Sponsor:

Virginia Commonwealth University

Code:

NCT06714929

Conditions

Dental Caries

Obesity Prevention

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Accepted

Interventions

Hydration

Study Details

Brief 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 drinking water.

Conditions

Dental Caries

Obesity Prevention

Study ID

NCT06714929

Start date

Aug 14, 2024

Status verified date

Jun, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Accepted

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 Design

Enrollment

7200 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Water Station Usage [ Time Frame: Years 1-3 ]
  • Dental Caries Status [ Time Frame: up to 3 years ]
  • Body Mass Index (BMI) [ Time Frame: up to 3 years ]

Central Contacts and Locations

Central contacts

Sarah Farthing, MS

804-527-4756sarah.malone@vcuhealth.org

Melanie K Bean, PhD

804-527-4765melanie.bean@vcuhealth.org

Locations

Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Recruiting

Henrico, Virginia, United States, 23229

Contacts

Sarah M Farthing, MS

804-527-4756sarah.malone@vcuhealth.org

Melanie K Bean, PhD

(804) 527-4765melanie.bean@vcuhealth.org

Principal Investigator:

Melanie K Bean, PhD

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

  • hydration
  • water
  • sugar-sweetened beverages
  • dental caries
  • overweight and obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-06-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.