Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction
Phase: PHASE3
Conditions: Food Preferences
Sponsor: University of Pennsylvania

 
 
 
 
 
 
 
 
 
 
 
 
Official Title: Preventing Non-communicable Diseases in Guatemala  
Through Sugary Drink Reduction  
NCT number: NCT04022694 
Document name: Protocol – Warning Label Aim 
Document date: November 6, 2017 

Page 1 of 17
Protocol Details
Basic Info
Conﬁrmation Number:
cfbfjijj
Protocol Number:
Created By:
WOOD, MAKENZIE H
Principal Investigator:
ROBERTO, CHRISTINA
Protocol Title:
Preventing non-communicable diseases in Guatemala through sugary drink reduction
Short Title:
Preventing non-communicable diseases in Guatemala
Protocol Description:
Guatemala is a lower middle income country with a rising prevalence of overweight and obesity. 
Because consumption of sugary drinks is strongly associated with obesity, policy makers are 
interested in strategies to reduce consumption. The proposed research will evaluate the impact of 
different types of sugary drink warning labels on adolescents purchases in Guatemalan schools
Submission Type:
Social and Biological Sciences
Application Type:
EXPEDITED Category 7
Resubmission*
No
Study Personnel
Principal Investigator
Name:
ROBERTO, CHRISTINA
Dept / School / Div:
10599 - ME-Division of Health Policy
Campus Address
Mail Code
6021
Address:
1110 BLOCKLEY HALL
423 GUARDIAN DR 
City State Zip:
PHILADELPHIA PA 19104-6021
Phone:
215-573-9718
Fax:
215-573-8779
Pager:
Email:
croberto@mail.med.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
01/02/2019
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA

Page 2 of 17
Study Contacts
Name:
WOOD, MAKENZIE H
Dept / School / Div:
10599 - ME-Division of Health Policy
Campus Address
Mail Code
6021
Address:
BLOCKLEY HALL 
423 GUARDIAN DR 
City State Zip:
PHILADELPHIA PA 19104-6021
Phone:
215-573-9179
Fax:
Pager:
Email:
makwood@gse.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
05/23/2020
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
Name:
HUA, SOPHIA V
Dept / School / Div:
10599 - ME-Division of Health Policy
Campus Address
Mail Code
6021
Address:
BLOCKLEY HALL 
423 GUARDIAN DR 
City State Zip:
PHILADELPHIA PA 19104-6021
Phone:
Fax:
Pager:
Email:
sohua@mail.med.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
07/17/2019
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
Name:
PETERHANS, ANA P
Dept / School / Div:
10599 - ME-Division of Health Policy
Campus Address
Mail Code
6021
Address:
BLOCKLEY HALL 
423 GUARDIAN DR 
City State Zip:
PHILADELPHIA PA 19104-6021
Phone:
215-573-9718
Fax:
-
Pager:
Email:
anapeter@mail.med.upenn.edu
HS Training Completed:
No
Training Expiration Date:
Name of course completed :

Page 3 of 17
Other Investigator
None
Responsible Org (Department/School/Division):
10599 - ME-Division of Health Policy
Key Study Personnel
None
Disclosure of Signiﬁcant Financial Interests*
Does any person who is responsible for the design, conduct, or reporting of this research protocol have 
a FINANCIAL INTEREST?
No
Penn Intellectual Property*
To the best of the Principal Investigator's knowledge, does this protocol involve the testing, 
development or evaluation of a drug, device, product, or other type of intellectual property (IP) that is 
owned by or assigned to the University of Pennsylvania?
No
Certiﬁcation
I have reviewed the Financial Disclosure and Presumptively Prohibited Conﬂicts for Faculty 
Participating in Clinical Trials and the Financial Disclosure Policy for Research and Sponsored 
Projects  with all persons who are responsible for the design, conduct, or reporting of this research; and 
all required Disclosures have been attached to this application.
Yes
Social and Biological Sciences
Study Instruments
Discuss the particulars of the research instruments, questionnaires and other evaluation instruments in 
detail. Provide validation documentation and or procedures to be used to validate instruments. For well 
know and generally accepted test instruments the detail here can be brief. More detail may be required 
for a novel or new instrument. For ethnographic studies identify any study instruments to be used (i.e. 
for deception studies) and describe in detail where, when and how the study will be conducted and who 
or what are the subjects of study. Note: For more information on how to conduct ethical and valid 
ethnographic research, follow the link For oral histories or interviews provide the general framework 
for questioning and means of data collection. If interviews or groups settings are to be audio taped or 
video taped describe in detail the conditions under which it will take place. Include a copy of any novel 
or new test instruments with the IRB submission. 
We describe all study measures in detail in the study design and procedures sections below and they 
appear in our appendices. Below is a brief summary of assessments. Purchasing Survey:  After 
obtaining permission from caregivers, a survey will be administered to students after they have made a 
food or beverage purchase at a school store. The survey will assess participants nutrition knowledge and 
label awareness, recall, and use, and trust in label information. Frequency of school store visits and 
sociodemographic characteristics (e.g., age, sex, race/ethnicity, grade level, and height and weight) will 
also be assessed (see Appendix B for survey). Beverage Frequency Questionnaire: Participants will also 
complete a beverage frequency questionnaire to assess their consumption of different types of 
beverages. This questionnaire will be based on the BEVQ-15, a survey instrument that has been 
validated as an effective tool used to capture changes in beverage consumption. (1-4) (see Appendix E 
for BEVQ-15). For each beverage category, the questionnaire assesses frequency of consumption and 
volume typically consumed. (see Appendix D for adapted questionnaire).
Group Modiﬁcations
Describe necessary changes that will or have been made to the study instruments for different groups.

Page 4 of 17
None of the survey questionnaires will differ across randomly assigned groups. Regarding the schools 
that will be enrolled in the study, pairs of matched private/public schools will be randomized to 1 of 3 
labeling conditions
Method for Assigning Subjects to Groups
Describe how subjects will be randomized to groups.
Individual participants will not be randomly assigned to groups. Instead, randomization will occur at 
the school level. Nine schools will be participating in this research and randomization will be stratiﬁed 
based on whether a school is public (n = 6) or private (n = 3). The Penn research team will use a 
random number generator to randomize schools to one of three labeling conditions, and the Guatemala 
team will implement the labels based on the randomization assignment.
Administration of Surveys and/or Process
Describe the approximate time and frequency for administering surveys and/or evaluations. For surveys, 
questionnaires and evaluations presented to groups and in settings such as high schools, focus group 
sessions or community treatment centers explain how the process will be administered and who will 
oversee the process. For instance, discuss the potential issues of having teachers and other school 
personnel administer instruments to minors who are students especially if the content is sensitive in 
nature. Describe the procedure for audio and videotaping individual interviews and/or focus groups and 
the storage of the tapes. For instance, if audio tape recording is to be used in a classroom setting, 
describe how this will be managed if individuals in the class are not participating in the study. Explain 
if the research involves the review of records (including public databases or registries) with identiﬁable 
private information. If so, describe the type of information gathered from the records and if identiﬁers 
will be collected and retained with the data after it is retrieved. Describe the kinds of identiﬁers to be 
obtained, (i.e. names, social security numbers) and how long the identiﬁers will be retained and 
justiﬁcation for use. 
Students and their caregivers will ﬁrst be contacted about study participation using a permission letter 
(see Appendix A) sent either as a printed letter or electronically. The letter will explain that their 
children may be asked to complete a short survey after making a purchase at the school store. 
Caregivers who wish to refuse participation can call a number provided in the permission letter. A list 
will be maintained with the names of students who have permission to participate. Research assistants 
will consult this list before administering any surveys to ensure the student has permission to 
participate. Adolescents who consent to participate and have made a purchase from the school store will 
be given the opportunity to complete a short survey; verbal assent must be obtained prior to enrollment. 
Research assistants will be stationed at the school stores during the heaviest trafﬁc times (between 
10:00am and 1:30pm and 2:30pm and 3:30pm) Monday to Friday and will invite adolescents to 
participate in the survey after they make a food and/or beverage purchase at the school store. Research 
assistants will record the item purchased (type of food/beverage) along with brand, quantity, size, and 
price. In addition, we will administer a survey that includes a validated beverage frequency 
questionnaire to assess typical beverage intake (Appendix B). Research assistants will also record the 
number of students who refuse participation along with their gender. The survey is estimated to last 
approximately 5-10 minutes. Participants will only be eligible to take the survey once.
Data Management
Describe how and who manages conﬁdential data, including how and where it will be stored and 
analyzed. For instance, describe if paper or electronic report forms will be used, how corrections to the 
report form will be made, how data will be entered into any database, and the person(s) responsible for 
creating and maintaining the research database. Describe the use of pseudonyms, code numbers and 
how listing of such identiﬁers will be kept separate from the research data. 
We will only use participant identiﬁcation numbers for data linkage purposes; we will not collect any 
participant names on the research questionnaires. The study identiﬁcation number, and no other 
identifying information, will be used on all data collection instruments. All study staff will be reminded 
to appreciate the conﬁdential nature of the data collected and contained in these databases. Only the 
researchers involved in this study and those responsible for research oversight will have access to the 
identiﬁable information provided. Risk of loss of conﬁdentiality will be minimized by storing surveys 
in locked ﬁle cabinets in locked ofﬁces accessible only to trained study staff. The surveys will be 
administered on paper and will not contain any identifying data. All completed surveys will be stored in 
a locked ﬁle cabinet in the secure ofﬁce of the INCAN team. Electronic data will be stored on secure, 
password-protected ﬁrewalled servers at INCAN in Guatemala and at UPENN. Only trained study staff 
will have access to the passwords used to access the databases. Data will be transferred from Guatemala 

Page 5 of 17
to Penn via PennBox, a secure folder for data storage.
Radiation Exposure*
Are research subjects receiving any radiation exposure (e.g. X-rays, CT, Fluoroscopy, DEXA, pQCT, 
FDG, Tc-99m, etc.) that they would not receive if they were not enrolled in this protocol?
No
Human Source Material*
Does this research include collection or use of human source material (i.e., human blood, blood 
products, tissues or body ﬂuids)?
No
CACTIS and CT Studies*
Does the research involve Center for Advanced Computed Tomography Imaging Services (CACTIS) 
and CT studies that research subjects would not receive if they were not part of this protocol?
No
CAMRIS and MRI Studies*
Does the research involve Center for Advanced Magnetic Resonance Imaging and Spectroscopy 
(CAMRIS) and MRI studies that research subjects would not receive if they were not part of this 
protocol?
No
Cancer Related research not being conducted by an NCI cooperative group*
Does this protocol involve cancer-related studies in any of the following categories?
No
Medical Information Disclosure*
Does the research proposal involve the use and disclosure of research subject's medical information for 
research purposes?
No
CTRC Resources*
Does the research involve CTRC resources?
No
If the answer is YES, indicate which items is is provided with this submission:
Use of UPHS services*
Does your study require the use of University of Pennsylvania Health System (UPHS) services, tests or 
procedures*, whether considered routine care or strictly for research purposes?
No
Primary Focus*
Sociobehavioral (i.e. observational or interventional)
Protocol Interventions
Sociobehavioral (i.e. cognitive or behavioral therapy)
Drug
Device - therapeutic
Device - diagnostic (assessing a device for sensitivity or speciﬁcity in disease diagnosis)
Surgical
Diagnostic test/procedure (research-related diagnostic test or procedure)
Obtaining human tissue for basic research or biospecimen bank
x Survey instrument
None of the above

Page 6 of 17
The following documents are currently attached to this item:
There are no documents attached for this item.
Sponsors
Business Administrator
Name:
KENNEDY-SMITH, NANCY J
Dept / School / Div:
10599 - ME-Division of Health Policy
Phone:
215-573-2769
Fax:
215-573-8778
Pager:
Email:
KENNEDYN@MAIL.MED.UPENN.EDU
Department budget code
400 - 400 - 4 - 572942 - 5348 - 2446 - 4176
Funding Sponsors
Name:
FOGARTY INTERNATIONAL CENTER/NIH/DHHS
Type:
UPENN Federal
Funding sponsors billing address
If you have selected a commercial or industry sponsor, please provide the appropriate address and 
contact information for the Sponsor for the purposes of billing for IRB review fees (initial review, 
continuing review and convened modiﬁcation fees apply here). If the Sponsor is not industry/
commercial, this information is not necessary to provide with your application.
Funding sponsors gift
Is this research being funded by a philanthropic gift?
No
Regulatory Sponsor
IND Sponsor
none
400 - 400 - 4 - 572942 - 5348 - 2446 - 4176
Industry Sponsor
None
Project Funding*
Is this project funded by or associated with a grant or contract?
Yes
Selected Proposals
Proposal No
Title
10061549
Preventing non-communicable diseases in Guatemala through sugary drink reduction and capacity bui

Page 7 of 17
Sponsor Funding
Is this study funded by an industry sponsor?
No
Status of contract
The following documents are currently attached to this item:
Grant Application (roberto-ssbwarninglabelsguatemalar21-ﬁnal.docx)
Multi-Site Research
Other Sites
No other sites
Management of Information for Multi-Center Research
As co-principal investigators, Drs. Roberto and Barnoya will meet by Skype conference calls weekly to 
assess the interim results and the coordination of any modiﬁcations to the protocol. In the event that any 
unanticipated problems involving risk to participants or others occurs, the co-principal investigators will 
communicate immediately to effectively address and manage these risks. Throughout the study a 
reliable and effective channel of communication will be upheld between both teams at INCAN and The 
University of Pennsylvania. There will be data and safety monitoring meetings every 6 months to more 
speciﬁcally assess the data quality, participant recruitment, accrual and retention, participant risk versus 
beneﬁt, and study outcomes. The research team will also correspond by email and telephone as needed. 
Only the researchers involved in these studies and those responsible for research oversight will have 
access to the identiﬁable information provided. In addition, the data collected as part of this study will 
not contain identifying information, which will therefore pose minimal risk to its participants.
The following documents are currently attached to this item:
There are no documents attached for this item.
Protocol
Abstract
Guatemala is a lower middle income country struggling with the double-burden of disease (malnutrition 
and obesity coexisting). Consumption of sugary drinks is strongly associated with obesity and related 
health problems. Food labeling has become a popular policy approach to address high levels of sugary 
drink intake. Some countries are interested in placing health warning labels on sugary drinks, but there 
are no real-world studies testing the effects of such labels. The aim of the proposed research is to test 
the effect of repeated exposure to warning labels on mean ﬂuid ounces of sugary drinks purchased by 
adolescents in Guatemala. We deﬁne a sugary drink as any non-alcoholic beverage that lists any form of 
caloric sugar-based sweetener as an ingredient (this would not include 100% juice). We will enroll nine 
schools in the study (three private and six public). Each group of matched private/public schools will be 
randomized to 1 of 3 labeling conditions. In this six-week study, we will collect sales data during two 
weeks without labels, two weeks when labels are displayed, and two weeks after labels have been 
removed. We will also conduct surveys with 1500 students.
Objectives
Overall objectives
The objective of this study is to conduct one of the ﬁrst ﬁeld experiments to assess the degree to which 
sugary drink warning labels encourage adolescents to reduce their intake in a country that does not yet 
have any front-of-package food labeling regulations. We will also evaluate whether a graphic-based 
warning label is more effective compared to a text-based warning label.

Page 8 of 17
Primary outcome variable(s)
The primary outcome will be mean ounces of sugary beverages purchased based on sales data, which 
will include the date of the transaction and the type of food or beverage sold (e.g., diet soda, lemonade) 
along with the item brand, size, quantity, and price.
Secondary outcome variable(s)
Our secondary outcomes will be the total kilocalories (kcals) purchased at the school store based on the 
surveys we collect. A measure of total calories purchased will allow us to assess whether adolescents 
who buy fewer sugary drinks compensate by buying other snack foods. We deﬁne a sugary drink as any 
non-alcoholic beverage that lists any form of caloric sugar-based sweetener as an ingredient (this would 
not include 100% juice). We will also record the presence and type of food/beverage marketing in the 
store.
Background
Overweight and obesity are estimated to account for 3.4 million deaths worldwide annually. (5) 
Although the prevalence of obesity in high-income countries is more than double that of low- or 
middle- income countries, the increase has been the fastest among those nations. (5) Guatemala is a 
lower middle income country struggling with the double-burden of disease (malnutrition and obesity 
coexisting). It has the second highest prevalence of childhood stunting in the world (49%) and a rising 
prevalence of overweight and obesity, particularly among women (49%). (6) This is concerning because 
obesity is a risk factor for numerous health problems, including type 2 diabetes, cardiovascular disease, 
and at least 13 different cancers. (7-12) Cancer is the third leading cause of mortality in Guatemala. 
(13) Most of the population (75%) lives below the poverty line (14) and Guatemala is one of the most 
unequal countries in the world. (15) These staggering statistics highlight the tremendous need for non-
communicable disease (NCD) research and capacity building in Guatemala. Consumption of sugary 
drinks is strongly associated with obesity and related health problems. (16-21) Global strategies to 
reduce sugary drink intake have been identiﬁed by the World Health Organization as a key need. (22) In 
Guatemala, sales of sugary drinks have increased 25% in the last decade (101 liters per capita) (23-24) 
and Guatemalas per capita intake is one of the highest worldwide (mean is 2.69 servings per day, higher 
than Mexico (2.40) and the United States (U.S.) (1.89)). (25) Food labeling is a policy approach gaining 
traction to encourage healthy choices. Over 20 countries have implemented mandatory or voluntary 
front-of-package or shelf tag nutrition labeling systems. (26) Chile has required health warning labels 
on packaged foods to alert consumers to high levels of certain nutrients. (27) Several U.S. states and 
cities have introduced bills to place warning labels on sugary drink containers or advertisements. 
(28-31) In 2011, Guatemala approved a regulation requiring a nutrition label (similar to the U.S. 
Nutrition Facts Label) on food packaging. However, the limited research on this label has found that 
only 27% of low socioeconomic status (SES) Guatemalan women report using the label and 78% have 
limited health literacy. (32) The label being difﬁcult to understand is the main reason reported for not 
using it. (32) For these reasons, multiple organizations including the Panamerican Health Organization 
(PAHO), (33) Central American Council of Ministries of Health, (34) and the Guatemalan National 
Commission of NCDs (35) have published reports recommending a uniform, easy-to-understand front-
of-package labeling system. Therefore, our proposed research testing different labels will provide 
timely data to inform these policy discussions. Signiﬁcant contributions of the proposed research. We 
expect the proposed study to provide the ﬁrst data on the impact of different types of sugary drink 
warning labels on adolescents purchases.
Study Design
Phase*
Not applicable
Design
This study will examine how repeated exposure to sugary drink warning labels inﬂuences total sales of 
sugary drinks over time as well as sugary drink purchases among 1500 adolescents.  School 
Recruitment: We will recruit nine schools to participate in this study. Three of the enrolled schools will 
be private (average tuition fees in private schools are $223.50 per month) and six will be public (free). 
Within private and public schools, we expect student body demographics to be similar based on income, 
age, and gender, respectively. Student Recruitment: Students and their corresponding caregivers will be 
recruited using an active-information, passive-consent permission process, which we have used for 
other research school-based studies in Guatemala. (36-41) Students between the ages of 12-18 and who 

Page 9 of 17
have shopped at one of the participating stores will qualify to participate. We will use the 
communication channel each school prefers (e.g., e-mail, printed letters sent home with students) to 
send permission letters to caregivers (see Appendix A). The letters will explain that their children may 
be asked to complete a short survey after making a purchase at the school store. Caregivers who wish to 
refuse participation can call a number provided in the permission letter. All students whose caregivers 
did not withdraw will be eligible to participate in the survey. Permission letters will be sent two weeks 
before data collection. Adolescents who have made a purchase from the school store will be asked if 
they want to complete a short survey; verbal assent must be obtained prior to enrollment (see Appendix 
C for oral consent script). School Store Setting: Nine schools will be participating in this research and 
randomization will be stratiﬁed based on whether a school is public (n = 6) or private (n = 3). The Penn 
research team will use a random number generator to randomize schools and the Guatemala team will 
implement the labels based on the randomization assignment. Each pair of matched private/public 
schools will be randomized to 1 of 3 labeling conditions: 1) calorie label (control); 2) text warning 
labels; or 3) graphic warning labels displaying amounts of sugar (see Appendix F).The warning label 
language will be translated into Spanish before the labels are implemented in the school stores. In this 
six-week study, we will receive purchasing data from the schools during two weeks without labels, two 
weeks when labels are displayed, and two weeks after labels have been removed Warning Label Survey: 
During the intervention weeks, we will survey approximately 1500 adolescents after they have made a 
purchase at the school store. We will stratify recruitment to ensure approximately half of the 1500 
surveyed students (n=750) are enrolled in public school and half (n=750) are enrolled in private school. 
Adolescents will be asked if they want to participate in a short, 5-10 minute survey. They will be 
offered a small prize (e.g., school supplies like pens or pencils) as a token of appreciation. The survey 
will include constructs that map onto our conceptual model of label effects, such as nutritional 
knowledge, label awareness, and trust of information on nutritional labels (see Appendix B for survey 
questions). We will also administer a beverage intake questionnaire (see Appendix D). This 
questionnaire has been validated among children and adolescents (42,43) Demographic Information: 
During the survey, we will ask participants to provide basic demographic information including age, 
sex, race/ethnicity, grade level, and height and weight (see Appendix B for demographic questions).  
Sales Data: We will collect sales data by setting up a point of sale system in each school store. This 
system will allow us to collect sales data from each store that will include a row for each purchase made 
at the school store, including the date of the transaction and the type of food or beverage sold (e.g., diet 
soda, lemonade) along with the item brand, size, quantity, and price. We will also record the presence 
and type of food/beverage marketing in the store.
Study duration
We anticipate it will take the entirety of the six week data collection period to survey all 1500 
adolescents. It will take 5-10 minutes for each participant to complete the survey. We aim to implement 
the warning labels in school stores by May 2018 and will complete the data collection by the end of 
June 2018.
Resources necessary for human research protection
Describe research staff and justify that the staff are adequate in number and qualiﬁcations to conduct 
the research. Describe how you will ensure that all staff assisting with the research are adequately 
informed about the protocol and their research related duties. Please allow adequate time for the 
researchers to conduct and complete the research. Please conﬁrm that there are adequate facilities for 
the research.
Characteristics of the Study Population
Target population
To be eligible for the survey component of this project, participants must be: 1) Between 12-18 years or 
older; 2) Be a currently enrolled student at one of the enrolled schools 3) Have made a purchase at the 
school store.
Subjects enrolled by Penn Researchers
0

Page 10 of 17
Subjects enrolled by Collaborating Researchers
1500
Accrual
The schools participating in this study will enable us to easily recruit students shopping at the school 
stores. With a sample size of 1500 (500 per labeling condition), this study is powered to detect small 
mean differences between the conditions. Speciﬁcally, if all three conditions differ by only .21 standard 
deviations, there is an 82% chance that we would ﬁnd all differences to be signiﬁcant.
Key inclusion criteria
To be eligible for the survey component of this project, participants must be: 1) Between 12-18 years or 
older; 2) Be a currently enrolled student at one of the enrolled schools 3) Have made a purchase at the 
school store.
Key exclusion criteria
Individuals not meeting the inclusion criteria above will be excluded. Those who will not or cannot give 
assent will also be excluded from the study. No one will be excluded on the basis of sex or race
Vulnerable Populations
x Children Form
Pregnant women (if the study procedures may affect the condition of the pregnant woman or 
fetus) Form
Fetuses and/or Neonates Form
Prisoners Form
Other
None of the above populations are included in the research study
The following documents are currently attached to this item:
Vulnerable Populations (inclusionofchildren.doc)
Populations vulnerable to undue inﬂuence or coercion
In addition to the safeguards that will be put in place to ensure adolescents participate in the study free 
from coercion, no results will be reported in a personally identiﬁable manner to further protect the 
identity of each participant.
Subject recruitment
School Recruitment: Nine schools will be participating in this research and randomization will be 
stratiﬁed based on whether a school is public (n = 6) or private (n = 3). The Penn research team will use 
a random number generator to randomize schools and the Guatemala team will implement the labels 
based on the randomization assignment.  Student Recruitment: Students and their corresponding 
caregivers will be recruited using an active-information, passive-consent permission process, which we 
have used for other research school-based studies in Guatemala. Students between the ages of 12-18 
and who have shopped at one of the participating stores will qualify to participate. We will use the 
communication channel each school prefers (e.g., e-mail, printed letters sent home with students) to 
send permission letters to caregivers (see Appendix A). The letters will explain that their children may 
be asked to complete a short survey after making a purchase at the school store. Caregivers who wish to 
refuse participation can call a number provided in the permission letter. All students whose caregivers 
did not withdraw will be eligible to participate in the survey. Permission letters will be sent two weeks 
before data collection. Adolescents who have made a purchase from the school store will be asked if 
they want to complete a short survey; verbal assent must be obtained prior to enrollment.
Will the recruitment plan propose to use any Penn media services (communications, marketing, etc.) for 
outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or does 
the study team plan to directly use social media to recruit for the research?
No

Page 11 of 17
The following documents are currently attached to this item:
There are no documents attached for this item.
Subject compensation*
Will subjects be ﬁnancially compensated for their participation?
No
The following documents are currently attached to this item:
There are no documents attached for this item.
If there is subject compensation, provide the schedule for compensation per study visit or session 
and total amount for entire participation, either as text or separate document
Subjects will not be ﬁnancially compensated for their participation. However, students will be offered a 
small prize (e.g., school supplies like pens or pencils) as a token of appreciation for their participation.
Study Procedures
Suicidal Ideation and Behavior
Does this research qualify as a clinical investigation that will utilize a test article (ie- drug or biological) 
which may carry a potential for central nervous system (CNS) effect(s)?
No
Procedures
Research assistants will be stationed at the school stores during the heaviest trafﬁc times (between 
10:00am and 1:30pm and 2:30pm and 3:30pm) Monday to Friday and will invite adolescents to 
participate in the survey after they make a purchase at the school stores. Only after conﬁrming that a 
student has permission to participate will the survey be administered. They will be offered a small prize 
(e.g., school supplies like pens or pencils) as a token of appreciation. After the adolescent has provided 
verbal consent, a research assistant will record the item(s) purchased (type of food/beverage) along with 
brand, quantity, size, and price. We will also assess frequency of school store visits and 
sociodemographic characteristics (e.g., age, sex, race/ethnicity, grade level, and height and weight). We 
will recruit 1500 students (between 12 and 18 years old) to answer a brief 5-10 minute survey after 
making a purchase at the school store. Nine schools will be participating in this research and 
randomization will be stratiﬁed based on whether a school is public (n = 6) or private (n = 3). The Penn 
research team will use a random number generator to randomize schools and the Guatemala team will 
implement the labels based on the randomization assignment (see Appendix F for label designs). In this 
six-week study, we will receive purchasing data from the schools during two weeks without labels, two 
weeks when labels are displayed, and two weeks after labels have been removed. Studying purchases 
after the labels have been removed will enable us to understand whether the labels are educating 
children over time or whether they primarily alter behavior by being a salient reminder at the point of 
purchase.
The following documents are currently attached to this item:
There are no documents attached for this item.
Deception
Does your project use deception?
No
Analysis Plan
Data will be descriptively summarized and evaluated for quality prior to the evaluation of primary and 
secondary endpoints. Means and standard deviations will be used to characterize the primary outcome 
variable of volume in ﬂuid ounces of sugary drinks purchased. We deﬁne a sugary drink as any non-
alcoholic beverage that lists any form of caloric sugar-based sweetener as an ingredient (this would not 

Page 12 of 17
include 100% juice). Frequencies and percentages will be 50 used to describe categorical variables such 
as percent of students purchasing a sugary drink. Medians and interquartile ranges will be reported for 
continuous variables that exhibit skewness. Data will be descriptively summarized overall and by 
labeling strategy. All outcomes will be analyzed at the purchase level. The mean volume of sugary 
drinks at each two-week period will be modeled among the calorie label, text label, and graphic label 
arms by a linear regression model including intervention arm, two-week period, interactions of period 
and intervention arm and type of school (private or public) as independent variables. We will conduct 
exploratory analyses to examine whether usual frequency of sugary drink intake (high versus low) and 
biological sex moderate label effects. Examining only aggregate sales data could lead to incorrect 
inferences. Therefore, complementary individual-level survey data on purchases will also be collected. 
This aggregate/individual-level data combination will improve inferences about label effects. Although 
stratiﬁcation by school type guarantees this variable will be balanced across our intervention arms, we 
are including it as a covariate in the model because it will enhance the precision of estimating 
intervention effects, as it explains variability in the outcome. The effectiveness of the interventions will 
be tested by evaluating the null hypothesis that the coefﬁcients of the interactions of period and 
intervention are 0, indicating no change in the difference in volume of sugary beverages purchased 
across intervention arms from baseline. To account for clustering of purchases within schools, test 
statistics will be corrected using the variance inﬂation factor (VIF) as determined by the estimated 
intraclass correlation coefﬁcient (ICC) for within school correlation. Primary and secondary outcomes 
in the calorie, text-based warning label, and graphic warning label arms will each be compared to one 
another. A Bonferroni-holm correction will be applied to control for multiple comparisons. We do not 
expect substantial missing data due to the point-of-sale technology we are using. The primary analysis 
will examine changes in labeled (sugary) and non-labeled beverages. Secondary analyses will examine 
changes for the following speciﬁc beverage categories: sugar-sweetened cola, sugar-sweetened sports 
drinks, sugar-sweetened lemonades/iced teas/juices, artiﬁcially-sweetened drinks (e.g., Diet Coke), 
milk, 100% fruit juice, unsweetened coffee/tea, and bottled water. For the survey data, we will conduct 
similar linear regression analyzes to compare total mean kcals purchased among intervention arms.
The following documents are currently attached to this item:
There are no documents attached for this item.
Are you conducting research outside of the United States?
Yes
Does your research involve contact with blood or other bodily ﬂuids?
No

Page 13 of 17
Data conﬁdentiality
x Paper-based records will be kept in a secure location and only be accessible to personnel involved 
in the study.
x Computer-based ﬁles will only be made available to personnel involved in the study through the 
use of access privileges and passwords.
Prior to access to any study-related information, personnel will be required to sign statements 
agreeing to protect the security and conﬁdentiality of identiﬁable information.
x Wherever feasible, identiﬁers will be removed from study-related information.
A Certiﬁcate of Conﬁdentiality will be obtained, because the research could place the subject at 
risk of criminal or civil liability or cause damage to the subject's ﬁnancial standing, 
employability, or liability.
A waiver of documentation of consent is being requested, because the only link between the 
subject and the study would be the consent document and the primary risk is a breach of 
conﬁdentiality. (This is not an option for FDA-regulated research.)
Precautions are in place to ensure the data is secure by using passwords and encryption, because 
the research involves web-based surveys.
Audio and/or video recordings will be transcribed and then destroyed to eliminate audible 
identiﬁcation of subjects.
Subject Conﬁdentiality
We will only use participant identiﬁcation numbers for data linkage purposes. The study identiﬁcation 
number, and no other identifying information, will be used on all data collection instruments. Data for 
the surveys will not contain personal identifying information. Instead, participants will be assigned a 
random number as an identiﬁer. All study staff will be reminded to appreciate the conﬁdential nature of 
the data collected and contained in these databases. Only the researchers involved in this study and 
those responsible for research oversight will have access to the identiﬁable information provided.  Risk 
of loss of conﬁdentiality will be minimized by storing surveys in locked ﬁle cabinets in locked ofﬁces 
accessible only to trained study staff. Electronic data will be stored on secure, password-protected 
ﬁrewalled servers at INCAN in Guatemala and at UPENN. Only trained study staff will have access to 
the passwords used to access the databases. Data will be transferred from Guatemala to Penn via 
PennBox a secure folder for data storage.
Sensitive Research Information*
Does this research involve collection of sensitive information about the subjects that should be excluded 
from the electronic medical record?
No
Subject Privacy
Privacy refers to the person's desire to control access of others to themselves. Privacy concerns people, 
whereas conﬁdentiality concerns data. Describe the strategies to protect privacy giving consideration to 
the following: The degree to which privacy can be expected in the proposed research and the safeguards 
that will be put into place to respect those boundaries. The methods used to identify and contact 
potential participants. The settings in which an individual will be interacting with an investigator. The 
privacy guidelines developed by relevant professions, professional associations and scholarly 
disciplines (e.g., psychiatry, genetic counseling, oral history, anthropology, psychology). 
The privacy of the subjects will not be infringed upon beyond a minimal degree. Participants will be 
identiﬁed based upon their enrollment in one of the six enrolled schools and their age (between the ages 
of 12-18 years old). Participants and their corresponding caregivers will be contacted for recruitment 
via permission letters that will be sent either electronically or as printed letters through the mail. 
Caregivers who wish to refuse participation can call a number provided in the permission letter and the 
student will no longer be eligible to participate. A list will be maintained with the names of students 
who have permission to participate. Research assistants will consult this list before administering any 
surveys to ensure the student has permission to participate Eligible participants will interact with a 
researcher while completing the survey only after they make a purchase at the school store and give 
verbal assent to complete the survey. The interaction will take place at the participants school. 
Participants will be assigned a random number as an identiﬁer to further protect their privacy.

Page 14 of 17
Data Disclosure
Will the data be disclosed to anyone who is not listed under Personnel?
The data will be disclosed to research assistants who will receive adequate training to help ensure data 
conﬁdentiality and subject privacy is upheld.
Data Protection*
Name
Street address, city, county, precinct, zip code, and equivalent geocodes
All elements of dates (except year) for dates directly related to an individual and all ages over 89
Telephone and fax number
Electronic mail addresses
Social security numbers
Medical record numbers
Health plan ID numbers
Account numbers
Certiﬁcate/license numbers
Vehicle identiﬁers and serial numbers, including license plate numbers
Device identiﬁers/serial numbers
Web addresses (URLs)
Internet IP addresses
Biometric identiﬁers, incl. ﬁnger and voice prints
Full face photographic images and any comparable images
Any other unique identifying number, characteristic, or code
x None
Does your research request both a waiver of HIPAA authorization for collection of patient information 
and involve providing Protected Health Information ("PHI") that is classiﬁed as a "limited data set" 
(city/town/state/zip code, dates except year, ages less than 90 or aggregate report for over 90) to a 
recipient outside of the University of Pennsylvania covered entity?
No
Tissue Specimens Obtained as Part of Research*
Are Tissue Specimens being obtained for research?
No
Tissue Specimens - Collected during regular care*
Will tissue specimens be collected during regulator clinical care (for treatment or diagnosis)?
No
Tissue Specimens - otherwise discarded*
Would specimens otherwise be discarded?
No
Tissue Specimens - publicly available*
Will tissue specimens be publicly available?
No
Tissue Specimens - Collected as part of research protocol*
Will tissue specimens be collected as part of the research protocol?
No

Page 15 of 17
Tissue Specimens - Banking of blood, tissue etc. for future use*
Does research involve banking of blood, tissue, etc. for future use?
No
Genetic testing
If genetic testing is involved, describe the nature of the tests, including if the testing is predicative or 
exploratory in nature. If predictive, please describe plan for disclosing results to subjects and provision 
of genetic counseling. Describe how subject conﬁdentiality will be protected Note: If no genetic testing 
is to be obtained, write: "Not applicable."
Not applicable.
Consent
1. Consent Process
Overview
Students and their corresponding caregivers will be recruited using an active-information, passive-
consent permission process. In this approach, we will use the communication channel each school 
prefers (e.g., e-mail, printed letters sent home with students) to send permission letters to caregivers. 
The letters will explain that their children may be asked to complete a short survey after purchasing 
food or beverage at the school store. Caregivers who wish to refuse participation can call a number 
provided in the permission letter. All students whose caregivers did not withdraw will be eligible to 
participate in the survey. Permission letters will be sent two weeks before data collection. Adolescents 
who have made a purchase from the school store will be asked if they want to complete a short survey. 
All adolescent participants will provide informed assent prior to participating in the survey (see 
Appendix C for oral consent script). At any time during the consent process or during the data 
collection, students will be allowed to decline participating or withdraw from the study. Study 
enrollment will include a description of the voluntary nature of participation, the study procedures, risks 
and potential beneﬁts. Adolescent participants will be told that they do not have to answer any questions 
if they do not wish and can drop out of the study at any time, without any penalty or loss of beneﬁts to 
which they are otherwise entitled. They will be told that they may not beneﬁt directly from the study 
and that all information will be kept strictly conﬁdential, except as required by law. All of this language 
will be tailored to adolescents.
Children and Adolescents
Please see above overview of consent process for description of consent process including parental 
permission and subject assent.
Adult Subjects Not Competent to Give Consent
All adult subjects will be competent to give informed consent.
2. Waiver of Consent
Waiver or Alteration of Informed Consent*
No Waiver Requested
Minimal Risk*
Impact on Subject Rights and Welfare*
Waiver Essential to Research*
Additional Information to Subjects
Written Statement of Research*
No

Page 16 of 17
If no written statement will be provided, please provide justiﬁciation
The following documents are currently attached to this item:
There are no documents attached for this item.
Risk / Beneﬁt
Potential Study Risks
There are minimal risks associated with the proposed study. The main risk is loss of conﬁdentiality, 
which will be protected as described below. There are no potential risks associated with any other 
measures or data to be collected. During the consent process, we will inform subjects of the risks 
associated with loss of conﬁdentiality.
Potential Study Beneﬁts
We expect the proposed study to provide the ﬁrst data on the impact of different types of sugary drink 
on adolescents purchases. We also expect this project to provide hands-on research training 
opportunities for Fogarty International Center trainees and fellows as well as educational opportunities 
for the broader INCAN research community.
Alternatives to Participation (optional)
Data and Safety Monitoring
As co-principal investigators, Drs. Roberto and Barnoya will meet by Skype conference calls weekly to 
assess the progress of the study. The biostatistician and research coordinators will also regularly join 
these calls. They will also have data and safety monitoring meetings every 6 months to more 
speciﬁcally assess the data quality, participant recruitment, accrual and retention, participant risk versus 
beneﬁt, and study outcomes. The research team will also correspond by email and telephone as needed. 
Only the researchers involved in these studies and those responsible for research oversight will have 
access to the identiﬁable information provided. The data collected as part of this study poses minimal 
risk to its participants.
The following documents are currently attached to this item:
There are no documents attached for this item.
Risk / Beneﬁt Assessment
Participants in this study will not receive any direct beneﬁts. Knowledge gained from the proposed 
series of studies will provide some of the ﬁrst real-world data on the potential effect of sugary drink 
warning labels on adolescents purchasing behavior. The proposed research will also examine novel 
labeling strategies to communicate the health harms of over consuming sugary drinks. This research can 
help inform nutrition policy efforts in Guatemala. The risks of loss of conﬁdentiality are minimal in this 
study. Thus, the beneﬁts of this research to society at large far surpass the risks.
General Attachments
The following documents are currently attached to this item:
Questionnaires (b.purchaseassessmentsurvey.pdf)
Questionnaires (d.beveverageintakequestionnaire.pdf)
Questionnaires (e.beverageintakesurvey-bevq.pdf)
Additional forms (f.labeldesignconditions.pdf)
Recruitment materials (c.oralconsentform.pdf)
Informed consent form (a.consentform.pdf)

Page 17 of 17
Cover Letter (coverletterguatemalawarninglabels.doc)
Supplemental form(s) (inclusionofchildren.doc)
Additional forms (references.pdf)