The Impact of the School Water Access on Child Food and Beverage Intake and Obesity
Phase: NA
Conditions: Obesity
Sponsor: Stanford University

 
 
 
 
School Water Access, Food and Beverage Intake, and Obesity 
Study Protocol 
NCT03181971 
February 29, 2024 

The Impact of the School Water Access on Child 
Food and Beverage Intake and Obesity  
NCT03181971 
August 17, 2021 
1. 
PURPOSE OF THE STUDY 
a. 
Brief Summary 
The overall goal of this cluster randomized, controlled trial involving 26 elementary 
schools is to examine how a drinking water promotion intervention impacts students’ 
intake of beverages and food, and obesity. Data from this study will inform policy and 
practice guidelines regarding how schools can effectively decrease students’ risk of 
obesity related to caloric intake from beverages. 
 
The study aims are to: 
     1. To examine how a school-based program to promote drinking water access and 
consumption in low-income public schools affects caloric intake from beverages. 
     2. To investigate how the school-based water promotion intervention affects caloric 
intake from food. 
     3. To assess whether the school-based water promotion intervention impacts the 
prevalence of overweight/obesity. 
b. 
Objectives 
Our central hypothesis is that, in low-income, public elementary schools, increased 
access to fresh water and rigorous promotion of its consumption will reduce students’ 
intake of caloric beverages thereby leading to lower obesity rates. We also hypothesize 
that the intervention will not adversely affect students’ caloric intake from food. 
   
Aim 1. To examine how a school-based program to promote drinking water access and 
consumption in low-income public schools affects intake of water and calories from 
beverages. We hypothesize that the intervention will increase intake of water and 
decrease intake of daily beverage calories. 
   
Aim 2. To investigate how the school-based water promotion intervention affects caloric 
intake from food. We hypothesize that the intervention will decrease daily food calories 
consumed. 
   
Aim 3. To assess whether the school-based water promotion intervention impacts the 
prevalence of overweight/obesity. We hypothesize there will be a greater decrease in the 
percentage of students who are overweight/obese in intervention schools as compared to 
control schools. 
 

August 17, 2021 
 
Page 2 of 12 
 
This study is significant because it is a first step toward developing effective 
interventions and policies that will encourage the consumption of healthy beverages 
among children and their families. Such improvements in beverage consumption patterns 
provide a unique opportunity to prevent undesired health outcomes such as obesity or 
dental caries via a discrete behavior change. 
 
c. 
Rationale for Research in Humans 
The purpose of the study is to examine the impact of improved access to safe and 
appealing drinking water and promotion of water intake instead of sugar-sweetened 
beverages on food and beverage intake and obesity among children. Schools were chosen 
for this research because they provide a setting for reaching a large population of 
children. 
2. 
STUDY PROCEDURES 
a. 
Procedures 
Each intervention site will receive school-wide intervention activities as well as activities 
for students in 4th grade classes only. School-wide intervention components include: 1) 
installation of three new drinking water sources in high-traffic common areas, including 
one in the cafeteria with single-use disposable cups; 2) a promotional campaign including 
a kick-off musical performance. We also post signage in classes and near newly installed 
drinking water sources. We will also place decals (green smiley faces) in the cafeteria 
next to healthy beverages (water and plain milk) and reinforce water intake by providing 
prizes to students observed drinking water in cafeterias.    
 
Classroom-specific intervention components include: 1) Provision of reusable water 
bottles for students to be filled each morning (with teacher supervision) and kept on or 
near students’ desks. Class teachers will also facilitate weekly cleaning of reusable water 
bottles. The research team will lead eight brief educational classroom lessons focused on 
the benefits of water consumption. These lessons were developed and refined in our 
previous studies. Family engagement activities will include home tools to reinforce 
educational content in class lessons (e.g., reusable water bottle for home) and homework 
activities (e.g., calculation of sugar in a drink at home). We will incentivize family 
involvement by providing prizes to students who complete homework. 
 
To assess how intervention activities impact caloric intake from food and beverages, we 
will use a multiple-pass 24-hour food and beverage diary protocol that has been adapted 
from a previously validated instrument. After diary completion, trained research staff will 
meet with students individually within 1-2 days of diary completion for approximately 20 
minutes to review the diary using a multiple-pass method. Because of the cuts made to 
the NIH grant budget, we will not complete food and beverage diaries at 15 months but 
will instead add a shorter beverage frequency questionnaire to assess intervention impacts 
on students' beverage intake from baseline to 15 months after the start of the study (this 
change is approved by NIH Program officer).  
 

August 17, 2021 
 
Page 3 of 12 
To assess BMI, we will follow standard procedures for obtaining length and weight as 
outlined in the National Health and Nutrition Examination Survey Anthropometry 
Procedures Manual. We will use privacy screens to take each student’s measurements 
one at a time in a private manner. At the same time at measurements are taken, we will 
conduct brief surveys with students about beverage intake, physical activity and screen 
time behaviors. Surveys will occur at baseline and at 7 months and 15 months after the 
start of the study. 
 
We will conduct surveys with the food service director and the principal at each school in 
order to monitor any new school-level policies or practices related to nutrition and 
physical activity that may impact study results. Surveys will occur at baseline and 15 
months after the start of the intervention. 
b. 
Procedure Risks 
This study, which involves surveying students about beverage and food intake and screen 
time and physical activity behaviors, as well as taking measurements of height and 
weight is of minimal risk to participants and includes no procedures for which written 
consent is normally required outside of the research setting. 
 
Interviews with food service directors and principals include non-sensitive information 
about school-level policies or practices related to nutrition and physical activity and are 
also of minimal risk to participants. 
 
While childhood obesity is a major public health concern, there remain undernourished 
children in the US who rely on Free or Reduced Price Meals (FRPM) for their daily 
caloric intake. Increased water consumption amongst these underweight children holds a 
small but important risk of increasing satiety, thereby reducing food consumption. For 
these children, we will take precautions. We will work with teachers and families 
(through consent processes) to identify students who have chronic diseases or conditions 
that require special dietary accommodations or who are underweight (BMI% < 5). We 
will then work with teachers and students’ families to develop individualized plans that 
allow students to participate in activities that do not interfere with the dietary 
prescriptions of physicians or nutritionists. For example, if a student drinks a special 
formula such as Pediasure® for poor weight gain, he/she could participate in classroom 
educational lessons but opt out of drinking water in the water bottle distributed to 
students. 
 
A Data Safety and Monitoring Board has been established to evaluate any adverse impact 
of the study on underweight children. They have determined that the study to date has not 
adversely affected underweight children in the intervention as compared to the control 
group. The board also feels that repeat measurements could stigmatize students. For this 
reason, we measure all students at the baseline, 7- and 15-months periods. 
 
If students are considered to be underweight at any point during the study period, 
researchers will contact the student's parents to discuss strategies for healthy weight 
management and recommend consultation with a pediatrician. 
 

August 17, 2021 
 
Page 4 of 12 
In this study, we will collect certain basic sociodemographic information so that we can 
assess how these factors relate to beverage consumption patterns and obesity. Such 
questions, however, will be kept at a minimum to decrease risk for participants. All 
identifying information will be kept separate from completed surveys and will only be 
linked to surveys through a numerical identification number. All personal information 
that we access will be stored as an encrypted data file on a password-protected desktop 
computer located in the PI’s locked office. Only trained research staff will have access to 
these data. All data will be coded with number-only identifiers. A name-identification 
number master code list (which will be destroyed once all data collection is completed) 
and data files will be stored in separate secure locations (computer and locked file 
cabinets in the PI locked office). 
c. 
Use of Deception in the Study 
NO 
d. 
Use of Audio and Video Recordings 
NO 
e. 
Alternative Procedures or Courses of Treatment 
There are no alternatives to study participation at this time. 
f. 
Will it be possible to continue the more (most) appropriate therapy for the 
participant(s) after the conclusion of the study? 
Schools that are selected as intervention schools will have access to changes in the built 
school environment that will remain at the school even after the study is complete (e.g., 
reusable water bottle filling stations and water dispensers in the cafeteria, physical 
activity area, and another common area). 
 
Schools will also have access to educational curricula and promotional materials if they 
choose to implement them on their own. Most materials are low cost and can be printed 
and reproduced by schools for a low-cost. 
 
Control schools will receive a reusable water bottle filling station and access to 
educational and promotional materials at the end of the study. 
 
All schools will receive $500 honoraria that can support continued education and 
promotion and/or any other health-related needs that the schools have at the time. 
 
g. 
Study Endpoint(s) 
While it is possible that there could be detectable differences in BMI outcomes during the 
course of the study, this is unlikely given previous studies that were used for effect size 
for power calculations. If there are any unanticipated impact on BMI prior to the end of 
the study or any adverse consequences, the Data Safety and Monitoring Board 
established for this study, will determine end points and action. Of note, the interventions 

August 17, 2021 
 
Page 5 of 12 
tested in this study (water station installation and promotion) are low-risk interventions 
and unlikely to have adverse consequences. 
3. 
BACKGROUND  
a. 
Past Experimental and/or Clinical Findings 
Reducing SSB consumption by promoting fresh drinking water is a promising childhood 
obesity prevention strategy. Sugar-sweetened beverages (SSBs) are a major, non-nutritive 
calorie source. Intake of SSBs is associated with obesity and related comorbidities, such 
as Type 2 diabetes. Yet low-income children – the population most affected by obesity – 
consume more SSBs than their higher income counterparts. If children replace fruit juice 
and SSBs with water, they can reduce their daily caloric intake by 235 kilocalories (kcal). 
In randomized controlled trials (RCTs), adolescents receiving allotments of non-caloric 
beverages (e.g., water) at home, experience reductions in SSB intake and obesity. In the 
only RCT of a school-based intervention, in 32 low-income elementary schools in 
Germany, installation of appealing water sources, coupled with classroom-based 
education, led to a 31% reduction in children’s risk of being overweight. However, in the 
German experiment, schools did not provide alluring alternatives to water, such as sugar 
sweetened milk and juice. Ours will be the first study to establish how best to promote 
water consumption in US public schools with SSBs, including flavored milk, and juice. 
   
US public schools are a key setting for promoting water consumption. Children spend 
substantial time in schools, so these settings offer an opportunity for increasing intake of 
water to replace SSBs. Most public schools are regulated by the 2010 Healthy Hunger-
Free Kids Act (HHFKA), which requires them to offer free water where meals are served, 
but not outside meals. The HHFKA law has so far not sufficiently increased children’s 
intake of water in schools. Currently, most schools comply by providing a single fountain 
for hundreds of students. In our observations of students in public schools, rates of water 
fountain use range from 2 to 11%. Concerns about the safety and palatability of water 
from fountains are inhibiting factors, along with poor maintenance and inadequate access. 
Providing more appealing water sources along with cups and reusable bottles may 
increase water intake in schools. In our survey of California public schools, only 20% 
offered a more appealing non-fountain water source and 18% provided cups or bottles. 
 
b. 
Findings from Past Animal Experiments 
N/A 
4. 
RADIOISOTOPES OR RADIATION MACHINES 
N/A 
5. 
DEVICES USED IN THE STUDY 
N/A 
6. 
DRUGS, BIOLOGICS, REAGENTS, OR CHEMICALS USED IN THE STUDY 
N/A 

August 17, 2021 
 
Page 6 of 12 
7. 
DISINFECTION PROCEDURES FOR MEDICAL EQUIPMENT USED ON BOTH HUMANS AND 
ANIMALS 
N/A 
 
8. 
PARTICIPANT POPULATION 
a. 
Planned Enrollment 
1690 4th grade student participants (avg 65 per school site x 26 sites) 
26 school administrators/principals (1 per school site x 26 sites) 
26 food service directors/workers (1 per school site x 26 sites) 
b. 
Age, Gender, and Ethnic Background 
The age range of the participants is 7-64 years. 
Gender composition: 51% male, 49% female 
Ethnic background: 53% Hispanic 
c. 
Vulnerable Populations 
Children: One main aim of this study is to understand how provision and promotion of 
drinking water in schools affects student intake of food and beverages and child 
overweight/obesity. Thus, it is important to include children in this research. 
   
Subjects unable to read, speak or understand English. Because the majority children in 
our study schools are Latino and may only speak Spanish, and some parents may only 
speak Spanish, we will not exclude Spanish-speaking populations in our study. 
 
We will ask parents to sign an informed consent form for their child to participate in the 
evaluation activities. Students will also be asked to sign a written assent before 
participating in evaluation activities. To encourage students to complete their food and 
beverage diaries, they will receive a $10-value gift card one time after completing both 
diaries at home with their parents. School-wide, students seen consuming water from 
newly installed water sources will also receive small incentives such as stickers or 
pencils. 
d. 
Rationale for Exclusion of Certain Populations 
We do not plan to exclude women or racial/ethnic groups from this study. Based on our 
previous experiences conducting research in school settings, study participants will likely 
be equally distributed between male and female gender. Given that one of our inclusion 
criteria is that schools have at least 50% of students who are eligible for free and reduced 
price meals (proxy for low-income households), our study population includes schools 
with a majority of non-White students. In our current study sample of 26 schools that 
have agreed to participate in the study, school populations are 66% Hispanic/Latino and 
6% Black/African American.  
e. 
Stanford Populations 

August 17, 2021 
 
Page 7 of 12 
None 
f. 
Healthy Volunteers 
None 
g. 
Recruitment Details 
Each school will receive an information letter describing the study and procedures. All 
students in 4th grade classes at participating schools will be sent home with an 
information letter and consent form for their parents. All principals and food service 
directors at participating schools will receive information letters and/or will attend 
meetings with research staff describing survey procedures. 
 
h. 
Eligibility Criteria 
i. 
Inclusion Criteria 
School-level inclusion criteria include traditional public schools serving low-income 
students (≥50% student eligible for free/reduced price meals) that are located in the 
greater San Francisco Bay Area. Individual-level inclusion criteria include students in 
4th grade classes in eligible intervention and control schools. We will also survey the 
food service director and the principal or other administrator at each participating 
school.  
ii. 
Exclusion Criteria 
Due to financial constraints of translation into other languages, we will exclude 
students or staff that cannot read and write in English and/or Spanish, and students 
whose parents cannot read and write in English and/or Spanish. 
   
Students with chronic diseases or conditions that require special dietary 
accommodations or who are underweight, meaning their BMI% is below 5%, will 
also be excluded from the study classroom activities if their BMI% decreases from 
baseline over the course of the study period.  
i. 
Screening Procedures 
1. Students - We will send information letters and consent forms in Spanish/English to 
parents of students in 4th grade classes at participating schools. The information letter will 
inform them of the study and will include the principal investigator’s contact information 
should they have any questions. Students who return consent forms will receive small 
incentives (e.g., pencils, stickers). As in our previous studies, we will visit schools to 
redistribute information letters and consent forms to students who have misplaced or lost 
forms. 4th grade students whose parents provide consent to participate in the evaluation 
will also be asked to provide their written assent prior to study participation. 
 
To retain study participants, we will provide incentives to participants, use detailed 
confidential tracking systems for students, and use refusal conversion techniques in 

August 17, 2021 
 
Page 8 of 12 
which we work with school staff and students to understand and overcome non-
participation and attrition. 
   
2. Schools - School-level inclusion criteria include traditional public schools serving low-
income students (≥50% student eligible for free/reduced price meals) that are located in 
the greater San Francisco Bay Area. We will recruit 13 elementary schools to serve as 
intervention sites and 13 elementary schools to serve as control sites 
   
3. Food Service Director and Principal - In order to track secular trends (i.e., nutrition and 
physical activity policies and practices at the school or district level) that may influence 
study outcomes, we will conduct web-based or paper surveys with food service directors 
and principals at intervention and control schools at baseline and 15 months after the start 
of the intervention. These data will be used to conduct exploratory analyses to help 
account for nutrition or physical activity improvements in schools that may also affect 
obesity. School food service directors and principals will be provided an information 
letter to inform them about the study with the principal investigator’s contact information 
if they should have any questions. Staff will be asked to sign consent forms prior to 
participation and they will receive a reusable water bottle for their assistance with the 
study. 
 
j. 
Participation in Multiple Protocols 
When recruiting schools, we ask school administrators about other studies the school is 
participating in. If the school is participating in a study that could impact our primary or 
secondary outcomes, we evaluate whether or not the school is eligible for the current 
study. At this time, there are no plans for participants to be enrolled in any other studies. 
k. 
Payments to Participants 
Participating intervention and control schools will receive a $500 honoraria to be used for 
physical activity or nutrition related activities. 
   
At intervention schools, $200 gift cards will be given to each participating 4th grade 
teacher. 
   
Participating 4th grade students at intervention and control schools will receive a $10-
value movie tickets after completing their final food/beverage diary. 
 
At intervention and control schools, staff will receive a $50 gift card for completing the 
two surveys. 
 
l. 
Costs to Participants 
NONE 
m. 
Planned Duration of the Study 
Entire study duration: 5 years 

August 17, 2021 
 
Page 9 of 12 
 
Food Service Director and Principal: Trained Stanford staff will interview the food 
service director and principal at the school at 2 time points, totaling 1.5 hours 
 
Students: Trained Stanford staff will deliver eight 15-minute interactive lessons about the 
benefits of drinking water. Food and beverage diaries, short surveys of physical activity, 
screen time, and beverage intake, and BMI data will be collected during 3 1-hour time 
points (food and beverage diaries will not be completed during 15 month follow-up). 
Total commitment will be approximately 5 hours. 
 
 
9. 
RISKS 
a. 
Potential Risks 
i. 
Investigational devices 
N/A 
ii. 
Investigational drugs 
N/A 
iii. 
Commercially available drugs, biologics, reagents or chemicals 
N/A 
iv. 
Procedures 
We will measure student height and weight using a standard National Health and 
Nutrition Examination Survey protocol. As schools routinely measure student height and 
weight as a part of routine Fitnessgram testing in grades 5, 7, and 9, both school staff and 
students will be familiar with these assessments. We will use techniques (e.g., one 
student measured at a time behind a privacy screen) to make sure that we preserve 
student privacy while taking measurements. Study participation or non-participation will 
not adversely affect participants’ involvement at the school and this study poses no risk 
greater than that encountered by students in everyday life experiences. We will take great 
effort to preserve participants’ privacy, but in the event that a loss of privacy occurs, it is 
conceivable that some students may become mildly embarrassed. 
 
v. 
Radioisotopes/radiation-producing machines 
N/A 
vi. 
Physical well-being 
We will ask participating students in 4th grade classes to complete food and beverage 
diaries and a survey regarding screen time, physical activity, beverage intake, and we will 
also measure student height and weight using a standard National Health and Nutrition 
Examination Survey protocol. As schools routinely measure student height and weight as 
a part of routine Fitnessgram testing in grades 5, 7, and 9, both school staff and students 

August 17, 2021 
 
Page 10 of 12 
will be familiar with these assessments. We will use techniques (e.g., one student 
measured at a time behind a privacy screen) to make sure that we preserve student 
privacy while taking measurements. Study participation or non-participation will not 
adversely affect participants’ involvement at the school and this study poses no risk 
greater than that encountered by students in everyday life experiences. We will take great 
effort to preserve participants’ privacy, but in the event that a loss of privacy occurs, it is 
conceivable that some students may become mildly embarrassed. 
vii. 
Psychological well-being 
Study participation or non-participation will not adversely affect participants’ 
involvement at the school and this study poses no risk greater than that encountered by 
students in everyday life experiences. We will take great effort to preserve participants’ 
privacy, but in the event that a loss of privacy occurs, it is conceivable that some students 
may become mildly embarrassed. 
viii. 
Economic well-being 
N/A 
ix. 
Social well-being 
N/A 
x. 
Overall Evaluation of Risk 
Research not involving greater than minimal risk. 
b. 
International Research Risk Procedures 
N/A 
c. 
Procedures to Minimize Risk 
While childhood obesity is a major public health concern, there remain undernourished 
children in the US who rely on FRPM for their daily caloric intake. Increased water 
consumption amongst these underweight children holds a small but important risk of 
increasing satiety, thereby reducing food consumption. For these children, we will take 
precautions. We will work with teachers and families (through consent processes) to 
identify students who have chronic diseases or conditions that require special dietary 
accommodations. We will then work with teachers and students’ families to develop 
individualized plans that allow students to participate in activities that do not interfere 
with the dietary prescriptions of physicians or nutritionists. For example, if a 4th grade 
student drinks a special formula such as Pediasure® for poor weight gain, he/she could 
participate in classroom educational lessons but opt out of drinking water in the water 
bottle distributed to students. These students, however, would be excluded from 
evaluation activities. 
 
A Data Safety and Monitoring Board has been established to evaluate any adverse impact 
of the study on underweight children. Members of the board include experts in 
gastroenterology, hepatology, and nutrition, public health, general pediatrics, and 
epidemiology. They have determined that the study to date has not adversely affected 

August 17, 2021 
 
Page 11 of 12 
underweight children in the intervention as compared to the control group. The board also 
feels that repeat measurements could stigmatize students. For this reason, we measure all 
students at the baseline, 7- and 15-months periods. 
 
In this study, we will collect certain basic sociodemographic information so that we can 
assess how these factors relate to beverage consumption patterns and obesity. Such 
questions, however, will be kept at a minimum to decrease risk for participants. All 
identifying information will be kept separate from completed surveys and will only be 
linked to surveys through a numerical identification number. All personal information 
that we access will be stored as an encrypted data file on a password-protected desktop 
computer located in the PI’s locked office. Only trained research staff will have access to 
these data. All data will be coded with number- only identifiers. A name-identification 
number master code list (which will be destroyed once all data collection is completed) 
and data files will be stored in separate secure locations (computer and locked file 
cabinets in the PI locked office). 
d. 
Study Conclusion 
While it is possible that there could be detectable differences in BMI outcomes during the 
course of the study, this is unlikely given previous studies that were used for effect size 
for power calculations. If there are any unanticipated impact on BMI prior to the end of 
the study or any adverse consequences, the Data Safety and Monitoring Board 
established for this study, will determine end points and action. Of note, the interventions 
tested in this study (water station installation and promotion) are low-risk interventions 
and unlikely to have adverse consequences. 
e. 
Data Safety Monitoring Plan (DSMC) 
N/A 
f. 
Risks to Special Populations 
Research not involving greater than minimal risk. 
10. 
BENEFITS 
Students who participate in the intervention are likely to benefit from improved access to water in 
schools and increased knowledge about the importance of drinking water through improved 
beverage consumption patterns and improved weight status. Although the focus of this current 
proposal is to examine the effect of water provision and promotion on food and beverage intake 
patterns and obesity, there is also potential to impact health outcomes not measured in this study 
(e.g., dental caries). 
 
Students at control schools will not benefit from this intervention during the study period. It is 
possible, however, that water dispensers given to control schools following the study could lead 
to improved beverage intake patterns in control schools as well. This study is beneficial to the 
larger population because study results can inform policies and programs that encourage children 
and their families to drink water instead of caloric beverages with added sugar. Subject risk is 
minimal, especially when compared to the potential benefits of this research. 

August 17, 2021 
 
Page 12 of 12 
11. 
PRIVACY AND CONFIDENTIALITY 
All participant information and specimens are handled in compliance with the Health Insurance 
Portability and Accountability Act (HIPAA) and privacy policies of Stanford University, Stanford 
Health Care, and Stanford Children’s Health.