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This study will pilot a school-based stakeholder-informed hydration intervention and examine its feasibility and preliminary efficacy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | Placebo Comparator | Students and staff at the control school will participate in assessments only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Water Bottle Usage | % of students with water bottles in school | Baseline, mid point 1 (month 2), mid point 2 (month 3), post (month 4) |
| Hydration Station Usage | 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). |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie Bean | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23235 | United States |
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Two matched schools were randomly selected and assigned to either Intervention or Control group in Fall 2023. Thus, the students and personnel at each school were randomly assigned to the same group as the school they attended/worked at.
Schools participated in study activities throughout the 2023-2024 school year. A subset of the student population, third graders, were recruited to participate in biomedical assessments (anthropometrics and dental exams).
| ID | Title | Description |
|---|---|---|
| FG000 | Hydration Intervention - Students | Students at the intervention school will receive a school-based hydration intervention that includes a student-developed marketing campaign and incentivizes water bottles in school. Hydration Intervention: 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. Students will receive 1 hydration lesson per month that align with Standards of Learning. |
| FG001 | Hydration Intervention - Personnel | 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. Hydration Intervention: 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. |
| FG002 | Control - Students | Students at the control school will participate in assessments only. Control - Assessments Only: Assessments only |
| FG003 | Control - Personnel | Staff at the control school will participate in assessments only. Control - Assessments Only: Assessments only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Number of students enrolled, number of staff that completed a baseline survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydration Intervention - Students | Students at the intervention school will receive a school-based hydration intervention that includes a student-developed marketing campaign and incentivizes water bottles in school. Hydration Intervention: 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. Students will receive 1 hydration lesson per month that align with Standards of Learning. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age data were pre-specified to not be collected for this study for personnel |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Student Ambassadors recruited at the Intervention School, only. Only 3 students were approached for this role and all 3 agreed. | Posted | Count of Participants | Participants | 1 month (pre-intervention to baseline) |
|
Baseline through 4-month assessments (~5 months total).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hydration Intervention - Students | Students at the intervention school will receive a school-based hydration intervention that includes a student-developed marketing campaign and incentivizes water bottles in school. Hydration Intervention: 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. Students will receive 1 hydration lesson per month that align with Standards of Learning. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Farthing | Virginia Commonwealth University | 804-527-4756 | sarah.malone@vcuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 7, 2025 | May 8, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 7, 2025 | May 8, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Control - Assessments Only | Other | Assessments only |
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| Baseline & post (4 month) |
| Sugar-sweetened Beverages at Lunch | % of students with sugar-sweetened beverages at lunch | Baseline, midpoint 1 (month 1), midpoint 2 (month 2), post (month 4) |
| Dental Caries Status - Teeth | 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 | 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) |
| Body Mass Index | NHANES Anthropometry methods used to measure height and weight | Baseline and post (month 4) |
| BG001 | Hydration Intervention - Personnel | 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. Hydration Intervention: 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. |
| BG002 | Control - Students | Students at the control school will participate in assessments only. Control - Assessments Only: Assessments only |
| BG003 | Control - Personnel | Staff at the control school will participate in assessments only. Control - Assessments Only: Assessments only |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Elementary School Grade | Grade in which each student was enrolled | Personnel are not included in grade at enrollment as it is not applicable. | Number | Grade |
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| Control |
Control schools did not have student ambassadors. |
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| Primary | Retention of 3 Student Ambassadors | Percentage of student ambassadors who continued participation in their role throughout the intervention period (intervention group only). | Student ambassadors were recruited in the intervention group only. | Posted | Count of Participants | Participants | 4 months |
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| Primary | 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. | Number of staff who completed the survey in the intervention group, only. The number of participants analyzed for this measure is based off the total number of personnel who answered the satisfaction question on the post-intervention [4-month] survey. 25 staff completed some portion of the survey but only 22 answered this specific question. | Posted | Count of Participants | Participants | Post (month 4) |
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| Primary | Implementation of Intervention Activities. | Percentage of intervention activities conducted per protocol | The number of planned core intervention activities that occurred according to protocol (intervention group, only). Activities implemented by teachers, not reported here. | Posted | Count of Units | Core intervention activities | 4 months | Core intervention activities | Core intervention activities |
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| Secondary | Water Bottle Usage | % of students with water bottles in school | Number of students enrolled at the school and observed on the assessment date. This number differs from the total student participants at each school due to student absences, therefore were not observed at the observational assessment. | Posted | Count of Participants | Participants | Baseline, mid point 1 (month 2), mid point 2 (month 3), post (month 4) |
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| Secondary | Hydration Station Usage | 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). | Water flowmeters monitored water usage from hydration stations in schools. Hydration station usage is measured by the total amount of ounces of water (across all hydration stations) per student, per school day. | Posted | Number | ounces of water used per student per day | Baseline & post (4 month) |
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|
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| Secondary | Sugar-sweetened Beverages at Lunch | % of students with sugar-sweetened beverages at lunch | Number of students enrolled. | Posted | Count of Participants | Participants | Baseline, midpoint 1 (month 1), midpoint 2 (month 2), post (month 4) |
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| Secondary | Dental Caries Status - Teeth | 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. | Number of 3rd grade students who provided assent, with parental consent, to participate in biomedical assessments. If students were not present the day of the assessment, then their data was not captured. | Posted | Median | Full Range | Teeth | Baseline and post (month 4) | Teeth | Teeth |
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| Secondary | Dental Caries Status - Teeth Surfaces | 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. | Number of 3rd grade students who provided assent, with parental consent, to participate in biomedical assessments. If students were not present the day of the assessment, then their data was not captured. | Posted | Median | Full Range | Teeth Surfaces | Baseline and post (month 4) | Teeth Surfaces | Teeth Surfaces |
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| Secondary | Body Mass Index | NHANES Anthropometry methods used to measure height and weight | Number of 3rd grade students who provided assent, with parental consent, to participate in biomedical assessments. If students were not present the day of the assessment, then their data was not captured. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline and post (month 4) |
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|
| 0 |
| 278 |
| 0 |
| 278 |
| 0 |
| 278 |
| EG001 | Hydration Intervention - Personnel | 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. Hydration Intervention: 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. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Control - Students | Students at the control school will participate in assessments only. Control - Assessments Only: Assessments only | 0 | 232 | 0 | 232 | 0 | 232 |
| EG003 | Hydration Intervention - School Personnel | Staff at the control school will participate in assessments only. Control - Assessments Only: Assessments only | 0 | 28 | 0 | 28 | 0 | 28 |
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| >=65 years |
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| Female |
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| Unknown/Not Reported |
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| White, not of Hispanic origin |
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| Asian |
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| Hispanic |
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| Non-Hispanic, two or more races |
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| Unknown/Not Reported |
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| Midpoint 1 |
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| Midpoint 2 |
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| Post |
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| Midpoint 1 |
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| Midpoint 2 |
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| Post |
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| Baseline: Decayed Missing and Filled Primary Teeth |
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| Post: Decayed Missing and Filled Permanent Teeth |
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| Post: Decayed Missing and Filled Primary Teeth |
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| Baseline: Decayed Missing and Filled Surfaces - Primary Teeth |
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| Post: Decayed Missing and Filled Surfaces - Permanent Teeth |
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| Post: Decayed Missing and Filled Surfaces - Primary Teeth |
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| Post |
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