CompletedNot Applicable

Healthy Hydration Pilot in Elementary Schools

United States563 participantsStarted 2023-11-09

Plain-language summary

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

Who can participate

Age range

4 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 month (pre-intervention to baseline)

Retention of 3 Student Ambassadors

Timeframe: 4 months

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

Timeframe: Post (month 4)

Implementation of Intervention Activities.

Timeframe: 4 months

Trial details

NCT IDNCT06132763

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-22

Results submitted2025-05-12

View on ClinicalTrials.gov More Hydration trials

Who can participate

Age range

4 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 1 month (pre-intervention to baseline)

Retention of 3 Student Ambassadors

Timeframe: 4 months

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

Timeframe: Post (month 4)

Implementation of Intervention Activities.

Timeframe: 4 months