Trial Outcomes & Findings for Healthy Hydration Pilot in Elementary Schools (NCT NCT06132763)
NCT ID: NCT06132763
Last Updated: 2025-10-31
Results Overview
Ability to recruit the required number of 4th or 5th grade student ambassadors at the intervention school at start of trial.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
563 participants
Primary outcome timeframe
1 month (pre-intervention to baseline)
Results posted on
2025-10-31
Participant Flow
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).
Unit of analysis: School
Participant milestones
| Measure |
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.
|
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.
|
Control - Students
Students at the control school will participate in assessments only.
Control - Assessments Only: Assessments only
|
Control - Personnel
Staff at the control school will participate in assessments only.
Control - Assessments Only: Assessments only
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
278 1
|
25 1
|
232 1
|
28 1
|
|
Overall Study
COMPLETED
|
278 1
|
25 1
|
232 1
|
28 1
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age data were pre-specified to not be collected for this study for personnel
Baseline characteristics by cohort
| Measure |
Hydration Intervention - Students
n=278 Participants
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.
|
Hydration Intervention - Personnel
n=25 Participants
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.
|
Control - Students
n=232 Participants
Students at the control school will participate in assessments only. Control - Assessments Only: Assessments only
|
Control - Personnel
n=28 Participants
Staff at the control school will participate in assessments only. Control - Assessments Only: Assessments only
|
Total
n=563 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
278 Participants
n=278 Participants • Age data were pre-specified to not be collected for this study for personnel
|
—
|
232 Participants
n=232 Participants • Age data were pre-specified to not be collected for this study for personnel
|
—
|
510 Participants
n=510 Participants • Age data were pre-specified to not be collected for this study for personnel
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=278 Participants • Age data were pre-specified to not be collected for this study for personnel
|
—
|
0 Participants
n=232 Participants • Age data were pre-specified to not be collected for this study for personnel
|
—
|
0 Participants
n=510 Participants • Age data were pre-specified to not be collected for this study for personnel
|
|
Age, Categorical
>=65 years
|
0 Participants
n=278 Participants • Age data were pre-specified to not be collected for this study for personnel
|
—
|
0 Participants
n=232 Participants • Age data were pre-specified to not be collected for this study for personnel
|
—
|
0 Participants
n=510 Participants • Age data were pre-specified to not be collected for this study for personnel
|
|
Sex/Gender, Customized
Sex · Male
|
149 Participants
n=278 Participants
|
0 Participants
n=25 Participants
|
119 Participants
n=232 Participants
|
0 Participants
n=28 Participants
|
268 Participants
n=563 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
129 Participants
n=278 Participants
|
0 Participants
n=25 Participants
|
113 Participants
n=232 Participants
|
0 Participants
n=28 Participants
|
242 Participants
n=563 Participants
|
|
Sex/Gender, Customized
Sex · Unknown/Not Reported
|
0 Participants
n=278 Participants
|
25 Participants
n=25 Participants
|
0 Participants
n=232 Participants
|
28 Participants
n=28 Participants
|
53 Participants
n=563 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black, not of Hispanic origin
|
154 Participants
n=278 Participants
|
0 Participants
n=25 Participants
|
101 Participants
n=232 Participants
|
0 Participants
n=28 Participants
|
255 Participants
n=563 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White, not of Hispanic origin
|
70 Participants
n=278 Participants
|
0 Participants
n=25 Participants
|
87 Participants
n=232 Participants
|
0 Participants
n=28 Participants
|
157 Participants
n=563 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
1 Participants
n=278 Participants
|
0 Participants
n=25 Participants
|
4 Participants
n=232 Participants
|
0 Participants
n=28 Participants
|
5 Participants
n=563 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
42 Participants
n=278 Participants
|
0 Participants
n=25 Participants
|
24 Participants
n=232 Participants
|
0 Participants
n=28 Participants
|
66 Participants
n=563 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic, two or more races
|
11 Participants
n=278 Participants
|
0 Participants
n=25 Participants
|
16 Participants
n=232 Participants
|
0 Participants
n=28 Participants
|
27 Participants
n=563 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Unknown/Not Reported
|
0 Participants
n=278 Participants
|
25 Participants
n=25 Participants
|
0 Participants
n=232 Participants
|
28 Participants
n=28 Participants
|
53 Participants
n=563 Participants
|
|
Region of Enrollment
United States
|
278 participants
n=278 Participants
|
25 participants
n=25 Participants
|
232 participants
n=232 Participants
|
28 participants
n=28 Participants
|
563 participants
n=563 Participants
|
|
Elementary School Grade
Pre-Kindergarten
|
19 Grade
n=278 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
—
|
0 Grade
n=232 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
—
|
19 Grade
n=510 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
|
Elementary School Grade
Kindergarten
|
44 Grade
n=278 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
—
|
44 Grade
n=232 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
—
|
88 Grade
n=510 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
|
Elementary School Grade
1st Grade
|
40 Grade
n=278 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
—
|
39 Grade
n=232 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
—
|
79 Grade
n=510 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
|
Elementary School Grade
2nd Grade
|
43 Grade
n=278 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
—
|
47 Grade
n=232 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
—
|
90 Grade
n=510 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
|
Elementary School Grade
3rd Grade
|
37 Grade
n=278 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
—
|
39 Grade
n=232 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
—
|
76 Grade
n=510 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
|
Elementary School Grade
4th Grade
|
43 Grade
n=278 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
—
|
25 Grade
n=232 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
—
|
68 Grade
n=510 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
|
Elementary School Grade
5th Grade
|
52 Grade
n=278 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
—
|
38 Grade
n=232 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
—
|
90 Grade
n=510 Participants • Personnel are not included in grade at enrollment as it is not applicable.
|
PRIMARY outcome
Timeframe: 1 month (pre-intervention to baseline)Population: Student Ambassadors recruited at the Intervention School, only. Only 3 students were approached for this role and all 3 agreed.
Ability to recruit the required number of 4th or 5th grade student ambassadors at the intervention school at start of trial.
Outcome measures
| Measure |
Hydration Intervention - Student Ambassadors
n=3 Participants
Student ambassadors served as hydration role models, identified "Hydration Heroes", monitored filter lights on hydration stations, \& updated the water meter visual throughout the intervention period. They also assisted with the Kick-off event at the start of the intervention.
|
Control
Control schools did not have student ambassadors.
|
|---|---|---|
|
Recruitment of Three 4th or 5th Grade Student Students to Assume the Role as Student Ambassador.
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Student ambassadors were recruited in the intervention group only.
Percentage of student ambassadors who continued participation in their role throughout the intervention period (intervention group only).
Outcome measures
| Measure |
Hydration Intervention - Student Ambassadors
n=3 Participants
Student ambassadors served as hydration role models, identified "Hydration Heroes", monitored filter lights on hydration stations, \& updated the water meter visual throughout the intervention period. They also assisted with the Kick-off event at the start of the intervention.
|
Control
Control schools did not have student ambassadors.
|
|---|---|---|
|
Retention of 3 Student Ambassadors
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Post (month 4)Population: 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.
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.
Outcome measures
| Measure |
Hydration Intervention - Student Ambassadors
n=22 Participants
Student ambassadors served as hydration role models, identified "Hydration Heroes", monitored filter lights on hydration stations, \& updated the water meter visual throughout the intervention period. They also assisted with the Kick-off event at the start of the intervention.
|
Control
Control schools did not have student ambassadors.
|
|---|---|---|
|
Number of School Personnel Participants Who Reported Being Satisfied With the Intervention
|
20 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: The number of planned core intervention activities that occurred according to protocol (intervention group, only). Activities implemented by teachers, not reported here.
Percentage of intervention activities conducted per protocol
Outcome measures
| Measure |
Hydration Intervention - Student Ambassadors
n=17 Core intervention activities
Student ambassadors served as hydration role models, identified "Hydration Heroes", monitored filter lights on hydration stations, \& updated the water meter visual throughout the intervention period. They also assisted with the Kick-off event at the start of the intervention.
|
Control
Control schools did not have student ambassadors.
|
|---|---|---|
|
Implementation of Intervention Activities.
|
17 Core intervention activities
|
0 Core intervention activities
|
SECONDARY outcome
Timeframe: Baseline, mid point 1 (month 2), mid point 2 (month 3), post (month 4)Population: 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.
% of students with water bottles in school
Outcome measures
| Measure |
Hydration Intervention - Student Ambassadors
n=240 Participants
Student ambassadors served as hydration role models, identified "Hydration Heroes", monitored filter lights on hydration stations, \& updated the water meter visual throughout the intervention period. They also assisted with the Kick-off event at the start of the intervention.
|
Control
n=211 Participants
Control schools did not have student ambassadors.
|
|---|---|---|
|
Water Bottle Usage
Baseline
|
34 Participants
|
17 Participants
|
|
Water Bottle Usage
Midpoint 1
|
123 Participants
|
41 Participants
|
|
Water Bottle Usage
Midpoint 2
|
113 Participants
|
35 Participants
|
|
Water Bottle Usage
Post
|
120 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Baseline & post (4 month)Population: 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.
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).
Outcome measures
| Measure |
Hydration Intervention - Student Ambassadors
n=278 Participants
Student ambassadors served as hydration role models, identified "Hydration Heroes", monitored filter lights on hydration stations, \& updated the water meter visual throughout the intervention period. They also assisted with the Kick-off event at the start of the intervention.
|
Control
n=232 Participants
Control schools did not have student ambassadors.
|
|---|---|---|
|
Hydration Station Usage
Baseline
|
0.125 ounces of water used per student per day
|
0.171 ounces of water used per student per day
|
|
Hydration Station Usage
Post (month 4)
|
0.153 ounces of water used per student per day
|
0.191 ounces of water used per student per day
|
SECONDARY outcome
Timeframe: Baseline, midpoint 1 (month 1), midpoint 2 (month 2), post (month 4)Population: Number of students enrolled.
% of students with sugar-sweetened beverages at lunch
Outcome measures
| Measure |
Hydration Intervention - Student Ambassadors
n=240 Participants
Student ambassadors served as hydration role models, identified "Hydration Heroes", monitored filter lights on hydration stations, \& updated the water meter visual throughout the intervention period. They also assisted with the Kick-off event at the start of the intervention.
|
Control
n=211 Participants
Control schools did not have student ambassadors.
|
|---|---|---|
|
Sugar-sweetened Beverages at Lunch
Baseline
|
33 Participants
|
26 Participants
|
|
Sugar-sweetened Beverages at Lunch
Midpoint 1
|
19 Participants
|
30 Participants
|
|
Sugar-sweetened Beverages at Lunch
Midpoint 2
|
27 Participants
|
32 Participants
|
|
Sugar-sweetened Beverages at Lunch
Post
|
27 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Baseline and post (month 4)Population: 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.
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.
Outcome measures
| Measure |
Hydration Intervention - Student Ambassadors
n=12 Teeth
Student ambassadors served as hydration role models, identified "Hydration Heroes", monitored filter lights on hydration stations, \& updated the water meter visual throughout the intervention period. They also assisted with the Kick-off event at the start of the intervention.
|
Control
n=12 Teeth
Control schools did not have student ambassadors.
|
|---|---|---|
|
Dental Caries Status - Teeth
Post: Decayed Missing and Filled Primary Teeth
|
1.0 Teeth
Interval 0.0 to 12.0
|
3.0 Teeth
Interval 0.0 to 8.0
|
|
Dental Caries Status - Teeth
Baseline: Decayed Missing and Filled Permanent Teeth
|
2.0 Teeth
Interval 0.0 to 6.0
|
2.0 Teeth
Interval 0.0 to 4.0
|
|
Dental Caries Status - Teeth
Baseline: Decayed Missing and Filled Primary Teeth
|
5.0 Teeth
Interval 0.0 to 12.0
|
1.5 Teeth
Interval 0.0 to 8.0
|
|
Dental Caries Status - Teeth
Post: Decayed Missing and Filled Permanent Teeth
|
0.0 Teeth
Interval 0.0 to 11.0
|
1.5 Teeth
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline and post (month 4)Population: 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.
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.
Outcome measures
| Measure |
Hydration Intervention - Student Ambassadors
n=56 Teeth Surfaces
Student ambassadors served as hydration role models, identified "Hydration Heroes", monitored filter lights on hydration stations, \& updated the water meter visual throughout the intervention period. They also assisted with the Kick-off event at the start of the intervention.
|
Control
n=56 Teeth Surfaces
Control schools did not have student ambassadors.
|
|---|---|---|
|
Dental Caries Status - Teeth Surfaces
Post: Decayed Missing and Filled Surfaces - Primary Teeth
|
2.0 Teeth Surfaces
Interval 0.0 to 46.0
|
5.0 Teeth Surfaces
Interval 0.0 to 40.0
|
|
Dental Caries Status - Teeth Surfaces
Baseline: Decayed Missing and Filled Surfaces - Permanent Teeth
|
5.0 Teeth Surfaces
Interval 0.0 to 14.0
|
3.0 Teeth Surfaces
Interval 0.0 to 9.0
|
|
Dental Caries Status - Teeth Surfaces
Baseline: Decayed Missing and Filled Surfaces - Primary Teeth
|
9.0 Teeth Surfaces
Interval 0.0 to 48.0
|
2.0 Teeth Surfaces
Interval 0.0 to 40.0
|
|
Dental Caries Status - Teeth Surfaces
Post: Decayed Missing and Filled Surfaces - Permanent Teeth
|
1.0 Teeth Surfaces
Interval 0.0 to 15.0
|
3.5 Teeth Surfaces
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: Baseline and post (month 4)Population: 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.
NHANES Anthropometry methods used to measure height and weight
Outcome measures
| Measure |
Hydration Intervention - Student Ambassadors
n=18 Participants
Student ambassadors served as hydration role models, identified "Hydration Heroes", monitored filter lights on hydration stations, \& updated the water meter visual throughout the intervention period. They also assisted with the Kick-off event at the start of the intervention.
|
Control
n=12 Participants
Control schools did not have student ambassadors.
|
|---|---|---|
|
Body Mass Index
Baseline
|
18.16 kg/m^2
Standard Deviation 2.90
|
18.7 kg/m^2
Standard Deviation 2.03
|
|
Body Mass Index
Post
|
18.8 kg/m^2
Standard Deviation 2.86
|
18.70 kg/m^2
Standard Deviation 2.55
|
Adverse Events
Hydration Intervention - Students
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hydration Intervention - Personnel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control - Students
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hydration Intervention - School Personnel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place