Communicating the Health Risks of Sugar-Sweetened Beverages: A Randomized-controlled Experiment of Different Nutrition Labels on Purchases and Consumption
Phase: NA
Conditions: Food Preferences
Sponsor: University of Pennsylvania

 
Online Study of the Effects of Sugary Drink Warning Labels on 
Consumption 
 
NCT05079477 
 
2021-08-24 
 
 
IRB Study Protocol and Analysis Plan 
 
 
 
 
 

Protocol 
Objectives 
Overall objectives 
The study objective is to determine to what degree sugar-sweetened beverages (SSB) warning labels increase 
consumers knowledge about the potential health harms of SSBs and reduce SSB intake. The study aims to assess the 
impact on purchasing behavior among adults of repeated exposure to SSB warning labels over time.  
 
Background 
Sugar-sweetened beverages (SSBs) significantly contribute to adult and childhood obesity: Nationally, two-thirds of 
adults and one-third of children are overweight or obese, with higher prevalence among Hispanics and blacks 
relative to whites (1,2). Excess weight is associated with numerous negative health, psychological, and economic 
consequences (3-9). No one food or beverage is solely responsible for obesity, but there are several reasons to target 
SSBs with policy interventions. Sugar-sweetened beverages are drinks with added caloric sweetener (e.g., soft 
drinks, fruit drinks, sports drinks, and flavored waters containing added sugars), and their consumption is strongly 
associated with obesity and obesity-related health problems, such as type 2 diabetes and cardiovascular disease (10-
18). Intake of SSBs has increased dramatically in the last several decades, and they now represent the largest source 
of added sugar in the American diet (19,20,42). SSBs are consumed at least once per day by 51% of adults and 64% 
of youth (43). Although soda consumption has recently declined modestly (44), consumption of other SSBs like 
sports drinks has increased (19), and todays overall level of SSB consumption remains disturbingly high (19,43). 
Further, Black and Hispanic individuals consume more kilocalories (kcals) from SSBs compared to white 
individuals (19). For these reasons, it is important to study interventions to reduce SSB intake among racially and 
ethnically diverse adults and children. 
Nutrition labeling widely used by policy makers, but label design affects degree of impact: Mandatory and voluntary 
front-of-pack or shelf-tag nutrition labeling systems have been implemented in over 20 countries (45). In the U.S., 
calories per bottle labels now appear on the front of most beverages (46) and chain restaurants soon must display 
kcal information on menus (47). Recently, legislative bills were introduced in California (21), New York State (22), 
Baltimore (23), and San Francisco (24) to require SSBs to display health warning labels on product containers 
and/or advertisements, much like tobacco warning labels. These warning labels are meant to educate consumers 
about the potential health harms of over-consuming SSBs and reduce consumption. A number of studies have shown 
that well-designed nutrition labels can influence behavior (48-58). Examples include: posters displaying SSB 
calories as minutes required to burn off the calories were associated with reductions in SSB corner store purchases 
among low-income adolescents (49). Traffic light labels have been associated with sustained decreases in unhealthy 
item sales and increases in healthy item sales in a hospital cafeteria (50). A randomized-controlled trial found that 
both traffic light and calorie labels encouraged 10% fewer calories purchased when employees ordered lunch ahead 
of time through an online portal (51). Supermarket studies have also found that front-of-package and shelf-tag labels 
influenced purchasing habits (52-58). Overall, food labels can influence behavior, but the design of the label 
matters. 
Effects of tobacco warning labels on knowledge and behavior: The evidence to date suggests tobacco graphic 
warnings can impact smoking behavior (28-33). Studies across four countries observed significant increases in calls 
to national telephone helplines after contact information was displayed within health warnings (28-33) and Canada 
saw a 6% drop in adult smoking prevalence following implementation of graphic warning labels (but graphic labels 
were introduced along with other tobacco control measures, making it difficult to isolate the independent effect of 
labels) (34). Research also shows that labels influence beliefs and intentions (25,27,59-65). Smokers in Australia 
were more likely to think about quitting and avoiding cigarettes after the implementation of large pictorial warnings 
(59). Significant proportions of smokers surveyed in countries with health warning labels have reported that the 
labels have motivated them to quit and/or influenced their behavior (60-66). One-fifth of Canadian (65) and two-
thirds of Australian (62) non-smoking youth reported that warnings helped prevent them from starting to smoke and 
approximately 90% of U.K. non-smoking youth reported that the warnings deterred them from smoking (61). 
Mechanisms of label influence: Research shows that tobacco graphic warning labels are more impactful than text 
labels (59,64,67-78) and both are more impactful than no label (25-33). Pictorial warnings are more effective than 
text warnings at increasing message salience, awareness, perception of smoking risks, and smokers desire to quit as 
well as preventing non-smokers from imitating (59,64,66-78). Graphic labels may be more effective than text 
because they elicit greater emotional reactions. Negative emotional reactions have been associated with increases in 
thinking about risks, intentions to quit, and quitting behaviors (66,70,75,79). Research also found that warnings 
depicting shocking images (e.g., rotten teeth, throat, mouth, or lung cancer, gangrenous foot, sick baby in a hospital) 

were rated as most effective and were more likely to be recalled by smokers (29,66,72,74-76,78,80-83). In addition, 
accompanying factual information written in a clear and direct manner increases message acceptance (66,72,76,84).  
While graphic labels with shocking images may be more effective than text-only labels, we decided to test sugar 
graphic warning labels which factually depict how much sugar is in each beverage. We are testing factual sugar 
graphic warning labels because they are more legally feasible than shocking images, capture attention, are easy to 
understand, and inform participants about the potential health risks of consuming added sugars. For these reasons, 
we hypothesize that sugar graphic warning labels will be more impactful than the calorie control condition.  
Significant contributions of the proposed research: We expect this research to provide the first causal data on the 
influence of SSB warning labels relative to standard kcal labels on purchasing and consumption behaviors. These 
data are much needed as warning label policies have been proposed in two U.S. states and two cities with little 
empirical evidence. The proposed work will provide an evidence base on the effects of such labels to guide both 
scientific inquiry and policymaking. 
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Study Design 
Design 
The primary objective of this study is to determine, before wide-scale implementation, to what degree SSB warning 
labels increase consumers knowledge about the potential health harms of SSBs and reduce SSB intake. This study 
will examine how repeated exposure to SSB warning labels influence adults' purchasing behaviors over time. 
Participants will be blindly randomized to 1 of 2 study conditions. Although participants will not know there are 
other conditions, it will be impossible to blind them to their own conditions as they will view the labels associated 
with their conditions. 
 
Study duration 
Participants will be randomized to 1 of 2 conditions and will buy snacks and beverages for four weeks via an online 
store. We anticipate it will take approximately one year to finish recruiting all subjects and for all subjects to 
complete the study. We will start recruiting subjects once IRB approval is obtained. 
 
Characteristics of the Study Population 
Target population 
We will recruit 216 racially and ethnically diverse parents from Philadelphia and the surrounding communities. 
Participants will need to be at least 18 years old, a primary caregiver of a child between the ages of 6 and 11, able to 
read and speak English, be the primary grocery shopper for their household, have regular Internet access, live in the 
Philadelphia area (within Amazon Fresh delivery radius), must purchase SSBs at least once per month and report 
that the oldest of their children between 6 and 11 years old is consuming SSBs at least twelve times per month or 

approximately three times a week. Additionally, participants must not have participated in the prior Warning Label 
Online Store study, or the Beverage Tax Evaluation study conducted by our research team. 
 
Subjects enrolled by Penn Researchers 
216 
 
Subjects enrolled by Collaborating Researchers 
0 
 
Vulnerable Populations 
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 
x None of the above populations are included in the research study 
The following documents are currently attached to this item: 
There are no documents attached for this item. 
 
Subject recruitment 
We will advertise through Craigslist. We will also leverage the resources and community relationships of the 
UPENN CDC-funded PRC co-directed by Drs. Glanz and Volpp (Co-Is) who both have a long track record of 
successfully working with local communities on research partnerships. We will also utilize Facebook Advertising 
through a Facebook page created for the study in order to reach more potential participants throughout the 
Philadelphia community (Craigslist language and Facebook flyer attached to this submission). Following all 
guidelines related to the COVID-19 pandemic, we will also hand out flyers directly to consumers and post them in 
neighborhoods if it is safe to do so.  
 
When individuals call in to inquire about the study, they will be asked a series of questions to determine if they are 
eligible for the study. 
 
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 
 
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? 
Yes 
 
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 
At the start of the study, participants will be given assigned money in the form of a store gift card to which 
researchers will add money throughout the course of the study. Participants will initially be given $15 to use to 
purchase items in the online store. Participants will be asked to purchase at least two items in the store each week 
(they must select at least one snack and one beverage). After purchasing at least two items during the first week, a 
participant's account will increase by $15 the following week as an incentive to remain in the study. For weeks three 
and four, participants will receive an additional $17 in their account to purchase more products in the store. 
Whatever money they do not spend in the online store will accrue over time and at the end of the study, they will be 
mailed a physical ClinCard (debit card) that will be loaded with the value of the unspent money as well as an 
additional $20 for completing the final survey. The total compensation for full participation is $84 per participant. 

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 
To conceal the study’s purpose, participants will be told that we are conducting consumer market research to learn 
about their experiencing shopping in an online snack store. Participants will be recruited on the phone. During this 
initial phone call, consent will be obtained and documented by the research assistant in REDCap, and participants 
will be given a tutorial about shopping in the online store. After the recruitment call, participants will be texted or 
emailed a link to a survey asking them to provide demographic information and beverage consumption information 
in a REDCap survey. They will also be mailed a welcome packet which includes a copy of the informed consent 
form, a Welcome Letter that gives them an overview of what they will be asked to do as well as answers to any 
frequently asked questions, in addition to an Online Store Guide to help participants navigate our online store 
interface (all attached to this submission). 
 
 
After consent is obtained, participants will be randomized to one of 2 label conditions in REDCap: 1) calorie labels 
(control); or 2) sugar graphic warning labels. Afterwards, participants will be emailed a web-link and password that 
will direct them to the store interface based on their label condition. Participants will be asked to shop in the store 
for a total of four weeks. For the first two weeks, participants will receive $15 in their online store account. For 
weeks three and four, participants will receive $17 in their online store account. For all of the weeks, participants 
will be asked to purchase at least one beverage and one snack from the online store. Each week participants will 
receive up to 3 text reminders to shop in the online store. If participants are non-responsive via text, we will send 3 
email reminders, and then 3 phone calls. Twice a day (excluding weekends) an RA will process and purchase the 
orders through our Amazon.com Prime account, which will enable us to ship the actual purchases within a few days. 
If for some reason Amazon Fresh does not have a product in stock, we will send the participant a replacement item. 
At the end of four weeks, research assistants will email or text participants with a REDCap link to a final survey for 
them to complete. After participants complete the final survey, a debriefing and consent form will appear on their 
screen. After participants read the debriefing statement, they will have the choice of either withdrawing from the 
study or indicating that it is still okay for the researchers to use their data (see attached). Participants will be required 
to answer this last question of consent before the survey can be considered completed. 
 
Upon study completion, participants will be mailed a final study packet which includes the following: 1) Study 
Conclusion Letter (thanks them for their participation and gives a brief overview of the next steps to activate their 
study debit card in the form of a ClinCard which we will use to pay them for their participation), 2) Study ClinCard 
and ClinCard FAQ (details information on how to use a ClinCard), 3) Final Debrief Information Sheet (paper copy 
of the debriefing form that they saw on the Final Survey). All forms are attached to this submission. 
 
The following documents are currently attached to this item: 
There are no documents attached for this item. 
 
Deception 
Does your project use deception? 
Yes 
 
A. Deception/incomplete disclosure is typically only acceptable in studies with no more than minimal risk. Please detail 
why this study is minimal risk. 
This study poses minimal risks. Participants will answer questions over the phone with a research participant, shop in a 
Shopify store, and complete self-report surveys via REDCap. No protected health information will be collected.  
 
B. The deception/incomplete disclosure should have no adverse effects on welfare. Please outline how all adverse effects 
are minimized. 
One potential risk is breach of confidentiality. We will minimize these risks by assigning a random participant 
identification number and stripping all identifying information from the dataset at the end of the study. All study data will 
be stored in REDCap and the PEACH Lab secure drive. Only the researchers involved in this study and those responsible 

for research oversight will have access to the identifiable information provided. Any de-identified data shared will be done 
so via PennBox, a secure method to transfer files.  
 
C. The IRB must determine that the value of the study is sufficient to warrant waiving some aspects of the requirement for 
full disclosure in the informed consent process. Please outline the scientific validity for using deception in this instance. 
There is some information about the study that we will not initially share with participants. It will be necessary to omit 
certain details on the first day of the study so that we can create a realistic situation that will allow participants to react 
genuinely and spontaneously without second-guessing their intuitive choices. To conceal the study’s purpose, participants 
will be told that we are conducting consumer market research about online shopping experiences and behaviors. We will 
explain that the online interface they are using may change throughout the study. 
 
D. There is no alternative to address the scientific question in a valid manner but to use deception/incomplete disclosure. 
Other effective, non-deceptive approaches are not feasible. Please detail why alternatives are not feasible. 
There is some information about the study that we will not initially share with participants. It will be necessary to omit 
certain details on the first day of the study so that we can create a realistic situation that will allow participants to react 
genuinely and spontaneously without second-guessing their intuitive choices. To conceal the study’s purpose, participants 
will be told that we are conducting consumer market research about online shopping experiences and behaviors. We will 
explain that the online interface they are using may change throughout the study. 
 
E. Debriefing is done, when appropriate, and the deception/incomplete disclosure is explained to the participant before the 
end of participation in the research. Please detail if you are debriefing participants, and if not, why not. 
All participants will be debriefed at the end of the study to inform them about the true study purpose. At the end of four 
weeks, research assistants will text or email participants with a REDCap link to a final survey for them to complete. After 
participants complete the final survey, a debriefing and consent form will appear on their screen. After participants read 
the debriefing statement, they will have the choice of either withdrawing from the study or indicating that it is still ok for 
the researchers to use their data. Participants will be required to answer the last question before the survey can be 
considered completed. 
 
F. When appropriate, subjects could be informed prospectively of the use of deception/incomplete disclosure and consent 
to its use: see the suggested consent language: "In some research studies, the investigators cannot tell you exactly what the 
study is about before you participate in the study. We will describe the tasks in the study in a general way, but we can't 
explain the real purpose of the study until after you complete these tasks. When you are done, we will explain why we are 
doing this study, what we are looking at, and any other information you should know about this study. You will also be 
able to ask any questions you might have about the study's purpose and the tasks you did. Though we may not be able to 
explain the real purpose of the study until after you complete the tasks, there are no additional risks to those that have 
been described in this consent form." 
There is some information about the study that we will not initially share with participants. It will be necessary to omit 
certain details on the first day of the study so that we can create a realistic situation that will allow participants to react 
genuinely and spontaneously without second-guessing their intuitive choices. To conceal the study’s purpose, participants 
will be told that we are conducting consumer market research about online shopping experiences and behaviors. We will 
explain that the online interface they are using may change throughout the study. 
 
International Research 
Are you conducting research outside of the United States? 
No 
 
Analysis Plan 
We will use a generalized estimating equation (GEE) modeling approach. Specifically, a linear GEE model of the 
transformed outcome (log10 (calories +1)) will be fit to a model with 1 categorical variable as the independent 
variable indicating the experimental condition (e.g., control is the reference) and an indicator for the corresponding 
measurement time (1, 2, 3, or 4 weeks). Such a model will allow us to examine overall treatment and time effects. 
Inferences will be adjusted appropriately to control the Type 1 error rate for multiple comparisons (e.g., Bonferroni).