N/A
N=563
Healthy Hydration Pilot in Elementary Schools
Hydration · Dental Caries · Body Mass Index
Bottom Line
View on ClinicalTrials.gov: NCT06132763 ↗Enrolled (actual)
563
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Recruitment of Three 4th or 5th Grade Student Students to Assume the Role as Student Ambassador. — 3; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hydration Intervention (Behavioral); Control - Assessments Only (Other)
- Age
- Pediatric, Adult, Older Adult · 4+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment of Three 4th or 5th Grade Student Students to Assume the Role as Student Ambassador. |
3; 0 | — |
| PRIMARY Retention of 3 Student Ambassadors |
3; 0 | — |
| PRIMARY Number of School Personnel Participants Who Reported Being Satisfied With the Intervention |
20; 0 | — |
| PRIMARY Implementation of Intervention Activities. |
17; 0 | — |
| SECONDARY Water Bottle Usage |
34; 17; 123; 41; 113; 35 | — |
| SECONDARY Hydration Station Usage |
0.125; 0.171; 0.153; 0.191 | — |
| SECONDARY Sugar-sweetened Beverages at Lunch |
33; 26; 19; 30; 27; 32 | — |
| SECONDARY Dental Caries Status - Teeth |
2.0; 2.0; 5.0; 1.5; 0.0; 1.5 | — |
| SECONDARY Dental Caries Status - Teeth Surfaces |
5.0; 3.0; 9.0; 2.0; 1.0; 3.5 | — |
| SECONDARY Body Mass Index |
18.16; 18.7; 18.8; 18.70 | — |
Summary
This study will pilot a school-based stakeholder-informed hydration intervention and examine its feasibility and preliminary efficacy.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06132763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.