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Completed

NCT Number: NCT06132763

Healthy Hydration Pilot in Elementary Schools

This study will pilot a school-based stakeholder-informed hydration intervention and examine its feasibility and preliminary efficacy.

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Key information

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23235, United States

About this study

Adequate water intake plays an important role in maintaining children's overall health, cognitive performance, fine motor skills and visual attention. It also plays a role in the maintenance of healthy weight. Many children do not consume sufficient water, especially in school. There is also potential that by providing enhanced access to water, there will be corresponding decreases in sugary beverage intake. Sugary beverages have been implicated as major contributors of excessive sugar and calorie intake in children, leading to multiple health concerns, such as type 2 diabetes, overweight and obesity, and dental caries. Schools are an optimal environment to increase children's water intake. Healthy hydration is a priority for Richmond Public School (RPS), as they recently adopted a new hydration policy into their school wellness policy, with hydration stations installed in all RPS schools. The purpose of this study is to determine the feasibility of a school-based hydration intervention. This study will pilot a school-based stakeholder-informed hydration intervention and examine its feasibility and preliminary efficacy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • 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.

Exclusion:

  • 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.

Treatment and study plan

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.

Control - Assessments Only

Other

Assessments only

Primary outcomes

  1. Recruitment of Three 4th or 5th Grade Student Students to Assume the Role as Student Ambassador.

    Time frame: 1 month (pre-intervention to baseline)

    Ability to recruit the required number of 4th or 5th grade student ambassadors at the intervention school at start of trial.

  2. Retention of 3 Student Ambassadors

    Time frame: 4 months

    Percentage of student ambassadors who continued participation in their role throughout the intervention period (intervention group only).

  3. Number of School Personnel Participants Who Reported Being Satisfied With the Intervention

    Time frame: Post (month 4)

    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.

  4. Implementation of Intervention Activities.

    Time frame: 4 months

    Percentage of intervention activities conducted per protocol

Secondary outcomes

  1. Water Bottle Usage

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

    % of students with water bottles in school

  2. Hydration Station Usage

    Time frame: Baseline & post (4 month)

    Ounces of water used per student per day over 4 months measured by hydration station flow meters. Flow meters captured all water usage in all hydration stations over the 4-month trial. Values were collected from the flow meters at baseline and post (4 months).

  3. Sugar-sweetened Beverages at Lunch

    Time frame: Baseline, midpoint 1 (month 1), midpoint 2 (month 2), post (month 4)

    % of students with sugar-sweetened beverages at lunch

  4. Dental Caries Status - Teeth

    Time frame: Baseline and post (month 4)

    measured by a modified International Caries Detection and Assessment System (ICDAS) using the DMFT (decayed, missing, and filled permanent teeth)/dmft (decayed, missing, and filled primary teeth) index. DMFT/dmft was defined as the total number of teeth with at least one decayed, missing, or filled tooth surface, with higher scores indicating worse dental health. Possible DMFT (permanent teeth) ranges are 0 to 28. Possible dmft (primary or baby teeth) ranges are 0 to 20.

  5. Dental Caries Status - Teeth Surfaces

    Time frame: Baseline and post (month 4)

    measured by a modified International Caries Detection and Assessment System (ICDAS) using the DMFS (decayed, missing, and filled permanent surfaces)/dmfs (decayed, missing, and filled primary surfaces) index. DMFS/dmfs was defined as the total number of tooth surfaces with decay, fillings, or that were missing due to decay, with higher scores indicating worse dental health. Possible DMFS ranges are 0 to 128 surfaces, as molars and premolars have 5 surfaces and incisors and canines have 4 surfaces, while for baby teeth, possible dmfs ranges from 0-88 surfaces.

  6. Body Mass Index

    Time frame: Baseline and post (month 4)

    NHANES Anthropometry methods used to measure height and weight

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

Addressing Root Causes of Under-hydration in School: A Stakeholder Collaborative Pilot Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 15, 2023
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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