Healthy Hydration Pilot in Elementary Schools

NCT06132763 | Completed Results

• 1 other identifier: HM20023592
• Study Type: interventional
• Target: 563
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Hydration; Water bottle; Sugary Beverages

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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.

  Post (month 4)

• Implementation of Intervention Activities.

  Percentage of intervention activities conducted per protocol

  4 months

Secondary Outcomes (6)

• Water Bottle Usage

  Baseline, mid point 1 (month 2), mid point 2 (month 3), post (month 4)

• Hydration Station Usage

  Baseline & post (4 month)

• Sugar-sweetened Beverages at Lunch

  Baseline, midpoint 1 (month 1), midpoint 2 (month 2), post (month 4)

• Dental Caries Status - Teeth

  Baseline and post (month 4)

• Dental Caries Status - Teeth Surfaces

  Baseline and post (month 4)

Study Arms (2)

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.

Behavioral: Hydration Intervention

Control

PLACEBO COMPARATOR

Students and staff at the control school will participate in assessments only.

Other: Control - Assessments Only

Interventions

Hydration Intervention BEHAVIORAL

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.

Hydration Intervention

Control - Assessments Only OTHER

Assessments only

Control

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Sarah Farthing
• Organization: Virginia Commonwealth University

sarah.malone@vcuhealth.org

804-527-4756

Study Officials

• Melanie Bean

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 15, 2023
• Study Start: November 9, 2023
• Primary Completion: April 22, 2024
• Study Completion: May 1, 2024
• Last Updated: October 31, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-10

Locations

US (1)