- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06132763
Healthy Hydration Pilot in Elementary Schools
Addressing Root Causes of Under-hydration in School: A Stakeholder Collaborative Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23235
- Virginia Commonwealth University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hydration Intervention
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.
|
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. |
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Placebo Comparator: Control
Students and staff at the control school will participate in assessments only.
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Assessments only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 month (pre-intervention to baseline)
|
|
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).
|
4 months
|
|
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.
|
Post (month 4)
|
|
Implementation of Intervention Activities.
Time Frame: 4 months
|
Percentage of intervention activities conducted per protocol
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index
Time Frame: Baseline and post (month 4)
|
NHANES Anthropometry methods used to measure height and weight
|
Baseline and post (month 4)
|
|
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
|
Baseline, mid point 1 (month 2), mid point 2 (month 3), post (month 4)
|
|
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).
|
Baseline & post (4 month)
|
|
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
|
Baseline, midpoint 1 (month 1), midpoint 2 (month 2), post (month 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.
|
Baseline and post (month 4)
|
|
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.
|
Baseline and post (month 4)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Melanie Bean, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20023592
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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