Body Mass Index, Dental Caries, Hydration
Conditions
Keywords
Hydration, Water bottle, Sugary Beverages
Brief summary
This study will pilot a school-based stakeholder-informed hydration intervention and examine its feasibility and preliminary efficacy.
Detailed description
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.
Interventions
BEHAVIORALHydration 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.
OTHERControl - Assessments Only
Assessments only
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment of Three 4th or 5th Grade Student Students to Assume the Role as Student Ambassador. | 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. |
| Retention of 3 Student Ambassadors | 4 months | Percentage of student ambassadors who continued participation in their role throughout the intervention period (intervention group only). |
| Number of School Personnel Participants Who Reported Being Satisfied With the Intervention | 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. |
| Implementation of Intervention Activities. | 4 months | Percentage of intervention activities conducted per protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dental Caries Status - Teeth Surfaces | 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. |
| Water Bottle Usage | Baseline, mid point 1 (month 2), mid point 2 (month 3), post (month 4) | % of students with water bottles in school |
| Body Mass Index | Baseline and post (month 4) | NHANES Anthropometry methods used to measure height and weight |
| Hydration Station Usage | 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). |
| Sugar-sweetened Beverages at Lunch | Baseline, midpoint 1 (month 1), midpoint 2 (month 2), post (month 4) | % of students with sugar-sweetened beverages at lunch |
| Dental Caries Status - Teeth | 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. |
Countries
United States
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 278 |
| 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. | 25 |
| Control - Students Students at the control school will participate in assessments only. Control - Assessments Only: Assessments only | 232 |
| Control - Personnel Staff at the control school will participate in assessments only. Control - Assessments Only: Assessments only | 28 |
| Total | 563 |
Baseline characteristics
| Characteristic | Hydration Intervention - Students | Total | Control - Students | Hydration Intervention - Personnel | Control - Personnel |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 278 Participants | 510 Participants | 232 Participants | — | — |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | — | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | — | — |
| Elementary School Grade 1st Grade | 40 Grade | 79 Grade | 39 Grade | — | — |
| Elementary School Grade 2nd Grade | 43 Grade | 90 Grade | 47 Grade | — | — |
| Elementary School Grade 3rd Grade | 37 Grade | 76 Grade | 39 Grade | — | — |
| Elementary School Grade 4th Grade | 43 Grade | 68 Grade | 25 Grade | — | — |
| Elementary School Grade 5th Grade | 52 Grade | 90 Grade | 38 Grade | — | — |
| Elementary School Grade Kindergarten | 44 Grade | 88 Grade | 44 Grade | — | — |
| Elementary School Grade Pre-Kindergarten | 19 Grade | 19 Grade | 0 Grade | — | — |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 1 Participants | 5 Participants | 4 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black, not of Hispanic origin | 154 Participants | 255 Participants | 101 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 42 Participants | 66 Participants | 24 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic, two or more races | 11 Participants | 27 Participants | 16 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Unknown/Not Reported | 0 Participants | 53 Participants | 0 Participants | 25 Participants | 28 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White, not of Hispanic origin | 70 Participants | 157 Participants | 87 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 278 participants | 563 participants | 232 participants | 25 participants | 28 participants |
| Sex/Gender, Customized Sex Female | 129 Participants | 242 Participants | 113 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Sex Male | 149 Participants | 268 Participants | 119 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Sex Unknown/Not Reported | 0 Participants | 53 Participants | 0 Participants | 25 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 278 | 0 / 25 | 0 / 232 | 0 / 28 |
| other Total, other adverse events | 0 / 278 | 0 / 25 | 0 / 232 | 0 / 28 |
| serious Total, serious adverse events | 0 / 278 | 0 / 25 | 0 / 232 | 0 / 28 |
Outcome results
Primary
Implementation of Intervention Activities.
Percentage of intervention activities conducted per protocol
Time frame: 4 months
Population: The number of planned core intervention activities that occurred according to protocol (intervention group, only). Activities implemented by teachers, not reported here.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Hydration Intervention - Student Ambassadors | Implementation of Intervention Activities. | 17 Core intervention activities |
| Control | Implementation of Intervention Activities. | 0 Core intervention activities |
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydration Intervention - Student Ambassadors | Number of School Personnel Participants Who Reported Being Satisfied With the Intervention | 20 Participants |
| Control | Number of School Personnel Participants Who Reported Being Satisfied With the Intervention | 0 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydration Intervention - Student Ambassadors | Recruitment of Three 4th or 5th Grade Student Students to Assume the Role as Student Ambassador. | 3 Participants |
| Control | Recruitment of Three 4th or 5th Grade Student Students to Assume the Role as Student Ambassador. | 0 Participants |
Primary
Retention of 3 Student Ambassadors
Percentage of student ambassadors who continued participation in their role throughout the intervention period (intervention group only).
Time frame: 4 months
Population: Student ambassadors were recruited in the intervention group only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydration Intervention - Student Ambassadors | Retention of 3 Student Ambassadors | 3 Participants |
| Control | Retention of 3 Student Ambassadors | 0 Participants |
Secondary
Body Mass Index
NHANES Anthropometry methods used to measure height and weight
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hydration Intervention - Student Ambassadors | Body Mass Index | Baseline | 18.16 kg/m^2 | Standard Deviation 2.9 |
| Hydration Intervention - Student Ambassadors | Body Mass Index | Post | 18.8 kg/m^2 | Standard Deviation 2.86 |
| Control | Body Mass Index | Baseline | 18.7 kg/m^2 | Standard Deviation 2.03 |
| Control | Body Mass Index | Post | 18.70 kg/m^2 | Standard Deviation 2.55 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hydration Intervention - Student Ambassadors | Dental Caries Status - Teeth | Baseline: Decayed Missing and Filled Permanent Teeth | 2.0 Teeth |
| Hydration Intervention - Student Ambassadors | Dental Caries Status - Teeth | Baseline: Decayed Missing and Filled Primary Teeth | 5.0 Teeth |
| Hydration Intervention - Student Ambassadors | Dental Caries Status - Teeth | Post: Decayed Missing and Filled Permanent Teeth | 0.0 Teeth |
| Hydration Intervention - Student Ambassadors | Dental Caries Status - Teeth | Post: Decayed Missing and Filled Primary Teeth | 1.0 Teeth |
| Control | Dental Caries Status - Teeth | Post: Decayed Missing and Filled Primary Teeth | 3.0 Teeth |
| Control | Dental Caries Status - Teeth | Baseline: Decayed Missing and Filled Permanent Teeth | 2.0 Teeth |
| Control | Dental Caries Status - Teeth | Post: Decayed Missing and Filled Permanent Teeth | 1.5 Teeth |
| Control | Dental Caries Status - Teeth | Baseline: Decayed Missing and Filled Primary Teeth | 1.5 Teeth |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hydration Intervention - Student Ambassadors | Dental Caries Status - Teeth Surfaces | Baseline: Decayed Missing and Filled Surfaces - Permanent Teeth | 5.0 Teeth Surfaces |
| Hydration Intervention - Student Ambassadors | Dental Caries Status - Teeth Surfaces | Baseline: Decayed Missing and Filled Surfaces - Primary Teeth | 9.0 Teeth Surfaces |
| Hydration Intervention - Student Ambassadors | Dental Caries Status - Teeth Surfaces | Post: Decayed Missing and Filled Surfaces - Permanent Teeth | 1.0 Teeth Surfaces |
| Hydration Intervention - Student Ambassadors | Dental Caries Status - Teeth Surfaces | Post: Decayed Missing and Filled Surfaces - Primary Teeth | 2.0 Teeth Surfaces |
| Control | Dental Caries Status - Teeth Surfaces | Post: Decayed Missing and Filled Surfaces - Primary Teeth | 5.0 Teeth Surfaces |
| Control | Dental Caries Status - Teeth Surfaces | Baseline: Decayed Missing and Filled Surfaces - Permanent Teeth | 3.0 Teeth Surfaces |
| Control | Dental Caries Status - Teeth Surfaces | Post: Decayed Missing and Filled Surfaces - Permanent Teeth | 3.5 Teeth Surfaces |
| Control | Dental Caries Status - Teeth Surfaces | Baseline: Decayed Missing and Filled Surfaces - Primary Teeth | 2.0 Teeth Surfaces |
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydration Intervention - Student Ambassadors | Hydration Station Usage | Baseline | 0.125 ounces of water used per student per day |
| Hydration Intervention - Student Ambassadors | Hydration Station Usage | Post (month 4) | 0.153 ounces of water used per student per day |
| Control | Hydration Station Usage | Baseline | 0.171 ounces of water used per student per day |
| Control | Hydration Station Usage | Post (month 4) | 0.191 ounces of water used per student per day |
Secondary
Sugar-sweetened Beverages at Lunch
% of students with sugar-sweetened beverages at lunch
Time frame: Baseline, midpoint 1 (month 1), midpoint 2 (month 2), post (month 4)
Population: Number of students enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hydration Intervention - Student Ambassadors | Sugar-sweetened Beverages at Lunch | Baseline | 33 Participants |
| Hydration Intervention - Student Ambassadors | Sugar-sweetened Beverages at Lunch | Midpoint 2 | 27 Participants |
| Hydration Intervention - Student Ambassadors | Sugar-sweetened Beverages at Lunch | Post | 27 Participants |
| Hydration Intervention - Student Ambassadors | Sugar-sweetened Beverages at Lunch | Midpoint 1 | 19 Participants |
| Control | Sugar-sweetened Beverages at Lunch | Post | 31 Participants |
| Control | Sugar-sweetened Beverages at Lunch | Baseline | 26 Participants |
| Control | Sugar-sweetened Beverages at Lunch | Midpoint 1 | 30 Participants |
| Control | Sugar-sweetened Beverages at Lunch | Midpoint 2 | 32 Participants |
Secondary
Water Bottle Usage
% of students with water bottles in school
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hydration Intervention - Student Ambassadors | Water Bottle Usage | Baseline | 34 Participants |
| Hydration Intervention - Student Ambassadors | Water Bottle Usage | Midpoint 1 | 123 Participants |
| Hydration Intervention - Student Ambassadors | Water Bottle Usage | Midpoint 2 | 113 Participants |
| Hydration Intervention - Student Ambassadors | Water Bottle Usage | Post | 120 Participants |
| Control | Water Bottle Usage | Post | 30 Participants |
| Control | Water Bottle Usage | Baseline | 17 Participants |
| Control | Water Bottle Usage | Midpoint 2 | 35 Participants |
| Control | Water Bottle Usage | Midpoint 1 | 41 Participants |