The Effectiveness of the Protection Motivation Theory in Reducing Vaping Behaviour in a Student Population
Phase: NA
Conditions: Vaping Related Disorder
Sponsor: Western University

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Study Protocol 
 
NCT Number: N/A 
 
Dec 14, 2020 

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Study Protocol 
 
Proposed Research Topic 
 
Using a Protection Motivation Theory framework to reduce vaping in a student population. 
 
Background and Significance 
 
According to Statistics Canada, more than one-third of Canadian students have tried vaping products at some point 
in their lives with the highest rates of trying vaping being among young adults (18-24 years). These data points 
reinforce the trend that vaping is becoming increasingly popular among Canadians, specifically among Canadian 
students. Although the levels of toxicants are lower in aerosol from vaping products compared to tobacco smoke, 
long-term exposure to e-cigarette vaping may lead to nicotine dependence and an increase in respiratory and 
cardiovascular health effects. In addition, though vaping has shown to assist with smoking cessation in adult 
smokers, the robust association between smoking and vaping could undermine reductions in smoking among young 
adults and increase their risk of subsequent smoking, and vice versa. The health outcomes of longstanding vaping 
behaviour are evident; however, the most effective means of limiting vaping behaviour, remains unclear. As the 
vaping market continues to evolve rapidly in North America, owed to the JUUL e-cigarettes and similar vaping 
products, research identifying effective health behaviour change strategies are becoming increasingly paramount. 
 
Specific Aims 
 
The aim of the proposed study is to investigate if/how the use of an 8-minute informational video, following the 
threat appraisal applications of the Protection Motivation Theory (PMT) framework, may help reduce and manage 
vaping intention and behaviour in Canadian university students. 
 
Hypothesis 
 
H1. Those exposed to threat appraisal information grounded in the PMT components of severity and vulnerability 
will show lower intention to vape and subsequent habitual vaping, compared to their attention information (general 
nutrition and lifestyle group) control counterpart. 
 
H2. Both severity and vulnerability of vaping usage will be associated with reduction in intentions to vape and 
overall vaping use among the PMT intervention group. 
 
Methods 
 
Submission for ethical approval will be presented to Western University’s Health Sciences Research Ethics Board. 
All participants included in this study will read the Letter of Information and submit an Informed Consent form prior 
to participation in the study. 
 
Participants 
 
Participants will (N=150) be full-time Canadian university students. Inclusion criteria include (1) aged 18 and over, 
2) ability to read and understand English, 3) have internet access, 4) self-report as current users of vaping products 
(vaping >3 in the past 30 days) 5) stated willingness to comply with all study procedures and availability for the 
duration of the study 6) enrolled full-time within a registered Canadian university during the 2020-2021 school year 
7) willingness to stop or at least decrease their frequency of vaping. Exclusion criteria includes (1) activity 
restrictions that limit one’s ability to engage in questionnaire testing and 2) currently practicing in behavior therapy 
treatment specific to vaping or attending a rehab center. Among participants recruited for the current study, we are 
interested in examining the potential behaviour changes in Canadian university students, both male and female, that 
identify as regular or casual vapers. The classifying of a Smoker scale (Berg et al., 2011) is used to assess criteria for 

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classifying regular and casual vapers, consisting of ten items rated on a 7-point Likert scales with anchors of 1 
“strongly disagree” to 7 “strongly agree”. Total scores are summed by items (i.e., I vape every week), with the 
aggregate values indicating the type of vaper they identify as. Participants will be recruited through public university 
student Facebook groups from across Canada. To facilitate the process, the SI will post a recruitment poster to the 
public page wall, instructing students to email the SI directly for further information, if interested. In addition, the SI 
will send out recruitment emails through the Mass Email Recruitment system at Western. 
 
Procedure 
 
Participants will be randomized into one of two treatment conditions: PMT present or PMT absent (attention 
control). Two separate online videos will be developed and delivered: One video incorporates the two major 
components of PMT threat appraisal; perceived vulnerability (PV) and perceived severity (PS), featuring specific 
vaping health consequence information, while the other features general nutrition and lifestyle information. At 
baseline, both groups will complete purpose-questionnaires which assess their beliefs towards vaping, their 
intentions to vape less, and their mood. At Time 1 (T1), following watching the intervention videos, self-reported 
measures of behaviour intention and vaping behaviour will be assessed and then repeated at 1 month (T2) and again 
two weeks after (T3). 
 
Timetable 
 
September 2020-August 2021 
 
Potential Limitations 
 
To date, the social restrictions as a result of the COVID-19 pandemic will inhibit our ability to contact participants 
in-person, instead we will contact and conduct the study through email communications. In adherence with these 
social restrictions, participants will self-report their behaviour-intention and action-behaviour for limited vaping 
through the questionnaires following intervention. As a result, we cannot corroborate their self-reporting vaping use. 
As vaping is a relatively new behaviour, there is no literature to support the notion that those who stop or reduce the 
amount that they vape will actually receive health benefits or minimize health costs. 
 
Significance/Impact of the Proposed Study? 
 
Since the spike in vaping-related illness in 2019, the Lung Association of Canada has been calling for stricter 
regulation of vaping products and aid in educating the public on the implications of vaping and strategies to help 
mitigate its use. Despite the attributable risk from vaping for oral, pharyngeal, and esophageal cancers, statistics 
Canada bears out that young adults were the most likely to think that vaping is less harmful than smoking at 27.9%, 
compared to 11.6% of users 25 and older; 10% having tried vaping without knowing whether or not it contained 
nicotine (Weikle, 2020). The function of this study is to identify if using a threat appraisal intervention with a PMT 
model can elicit significant change to ultimately reduce and manage vaping behaviour in Canadian university 
students. Through increasing the awareness of the risks associated with vaping within our PMT-present intervention 
group and illustrating the effectiveness of threat appraisal and PMT, we aim to illustrate the effectiveness of threat 
appraisal and PMT methods to influence health psychologists and public-health campaigns to instill these powerful 
health behaviour strategies in future efforts to reduce the percentage of Canadian students and young adults who 
vape. 

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Flow diagram of study procedures 
 

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Analysis Plan 
 
NCT Number: N/A 
 
Dec 14, 2020 

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Statistical Analysis Plan 
 
Data collected by the participants will be presented among 5 categories: Vulnerability, Severity, 
Intention, and Behaviour. All continuous data will be presented in means with standard 
deviation, median, and range. For primary and secondary endpoints, nominal scales will be used 
to assess single endpoint/summary measures. The statistical procedure will use a repeated 
measures ANOVA to measure outcomes at different times during the study timeline (e.g., 
Time1, Time2...). This repeated measure model will be used to average the repeated measures 
data for each study arm to perform the relative correlation. Similar to a Pearson correlation 
coefficient (r), the repeated measure correlation (rmcorr) model represents the strength of the 
linear association between the PMT intervention and the control arm. Also akin to the Pearson 
correlation, the null hypothesis for rmcorr is ρrm = 0, and the research hypothesis is ρrm ≠ 0. 
Unlike the Pearson correlation, which assesses the inter-individual association, rmcorr evaluates 
the overall or common intra-individual association between two measures. Following the 
strength of the repeated measures ANOVA analysis in multilevel modeling, we contend that this 
model of statistical analysis is appropriate for the utility of our iterative research study. 

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Letter of Informed Consent 
 
NCT Number: N/A 
 
Dec 14, 2020 

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Study Title: Information Interventions to Reduce Vaping in a Student Population 
 
Principal Investigator: 
Co-Investigator: 
Dr. Harry Prapavessis, PhD 
Babac Salmani, MA 
Department of Kinesiology 
Department of Kinesiology 
Western University 
Western University 
hprapave@uwo.ca 
bsalmani@uwo.ca 
 
INVITATION 
 
You are invited to participate in a study because you have self-described yourself as someone who vapes. The purpose of this 
study is to determine which types of sources of information are more effective in helping university students reduce their vaping 
habits. You are being invited to participate in this research study because, as a student, you are part of a population in Canada 
where the use of vaping products is relatively higher compared to the rest of the Canadian population. 
 
BACKGROUND INFORMATION 
 
According to Statistics Canada, more than one-third of Canadian students have tried vaping products at some point in their lives 
with the highest rates of trying vaping being among young adults (18-24 years). These data points reinforce the trend that vaping 
is becoming dangerously popular among Canadians, specifically among Canadian students. The purpose of this study is to find 
out what effects an individual’s behaviour-intention and action-behaviour and how we can potentially reduce and manage the 
uptake of vaping behaviour in Canadian students. 
 
WHAT’S INVOLVED 
 
Up to 150 students will participate in this study and it is expected that you will be in the study for six weeks. You will not have to 
pay for any of the procedures/interventions with this study. If you decide to participate then you will be “randomized into one of 
the groups described below.” Randomization means that you are put into a group by chance (like flipping a coin). Of the two 
groups providing information, each will consist of different content. Participants in either group are required to complete all four 
sets of surveys. There is no way to predict which group you will be assigned to. You will have 1 in 2 chance of being placed in 
either/any group. Neither you, nor the study staff can choose what group you will be in; group one will contain information 
regarding the risks associated with vaping to your overall health. Group two will focus on tips associated with diet choices and 
lifestyle. At the start of the six-week timeframe you will have to (all will be sent by the student investigator (SI) to the email you 
provide): 
 
• 
Complete a purpose-questionnaire and self-report questionnaires regarding vaping 
• 
Watch an 8-minute online video 
• 
Complete three self-report questionnaires over the remaining five-weeks of the study period 
 
The purpose of the questionnaires is to understand how your intention and desire to vape changes over time. The questionnaires 
will assess your past and current vaping behaviour, your perceptions of vaping, your intentions to try and reduce vaping 
behaviour, as well as assess some potential changes in mood. The questionnaires will be filled out at four time points: upon entry 
into the study (Day 1), one week later (Day 7), two weeks later (Day 30), and at the end of the study (Day 45). All questionnaires 
will be sent to the email you provide to the SI, following the schedule above. Each set of questionnaires will take about 15 
minutes to complete. 
 
The following exclusion criteria will effectively terminate your inclusion in this study and prevent your data from contribution to 
study analysis: 
Letter of Information and Consent 

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1. 
Activity restrictions that limit one’s ability to engage in questionnaire testing 
2. 
Currently practicing in behaviour therapy treatment specific to vaping or attending a rehab centre 
3. 
At the time of signing/submitting this consent form you are under the legal age of 18 
4. 
Failure to complete and submit completed questionnaires within the 7-day study timeframe, starting the day that set of 
surveys is emailed to you by the student investigator 
 
Participants will be notified immediately by the SI, via emails provided by individual participants, of their exclusion from the 
study and the immediate termination of their study data. 
 
POTENTIAL BENEFITS AND RISKS 
 
An understanding of what information has the greatest influence on behaviour in students will help to design more effective 
interventions to help reduce negative health behaviour in the future. In addition, you may learn more about the risks associated 
with vaping or potential nutrition and lifestyle tips, depending on which group you are in, that may have a positive influence on 
your health behaviour choices and overall health. A risk associated with participation in this study is the potential for preliminary 
stress and anxiety as a result of reflecting on behaviour through surveys. Apart from the application of intervention, as personal 
identifiers are being collected for this study, there is the risk of breach of privacy which may be a cause of added risk in 
participation. To combat this risk, we have implemented the safe storage of all identifiable data on a password-protected, 
encrypted Personal Vault via OneDrive to ensure participant privacy. As a participant, you may also experience no benefit from 
participation in this study. If you notice a greater sense of mental distress or anxiety as a result of participation in the study 
procedures, please contact Dr. Lisa Lee, a clinical psychologist as part of the study team, by email at info@drlisalee.com, or by 
phone at (519) 878-4912. In addition, the Counselling Services of London, specialized in anxiety therapy and self-esteem 
counselling, have offered their services as part of our study team at counselling@natashaminor.com or by phone at (226) 270- 
1242, to any participants who feel distress. Both study team resources offer online services for study participants. Lastly, please 
consider contacting the Centre for Addiction and Mental Health in Canada, at (519) 858-5144 if you feel the need for additional 
aid. 
 
SUMMARY OF TESTS AND PROCEDURES 
 
The schedule below is a representation of procedures that will be accomplished at each study stage. 
 

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CONFIDENTIALITY 
 
All information you provide is considered confidential; all identifiable information collected during this study will be kept 
confidential and will not be shared with anyone outside the study unless required by law. You will not be named in any reports, 
publications, or presentations that may come from this study. Data collected during this study will be stored on an encrypted, 
password-protected, locked external drive in a secure and confidential location for 7 years, as per Western’s data retention policy. 
Once the data retention period is over, the data will be analysed by the student investigator for significance and will be stored on 
a password-protected, encrypted Personal Vault via OneDrive. Access to this data will be restricted to the principal investigator 
and student investigator. Western University Health Sciences Research Ethics Board may require access to the study records to 
monitor the conduct of the research. The type of personal information that will be collected is age, gender, and ethnicity. Contact 
information of the participants will also be collected for this study. A description of this study will be available by contacting the 
student investigator at bsalmani@uwo.ca. You can contact the student investigator via email, at any time, regarding any 
questions and/or concerns related to this study. 
 
VOLUNTARY PARTICIPATION 
 
Participation in this study is voluntary. If you wish, you may decline to answer any questions or participate in any component of 
the study without effect on academic standing. Further, without effect on academic standing, you may also decide to withdraw 
from this study at any time. If you do wish to no longer be included in the study or you are removed as a participant and wish to 
withdraw your past questionaries from the study, you should tell the Principal Investigator, Dr. Harry Prapavessis, who will 
ensure no future data will be collected, the data related to your participation in the study will be removed, and you will no longer 
receive questionnaires from the study staff. You as a participant may be taken off the study if you are unable to tolerate the study 
intervention, if you are unable to complete all required study procedures, or if the research ethics board withdraws permission for 
this study to continue. If this happens, it may mean that you would not receive the study intervention for the full period described 
in this consent form. If you are removed from this study, the study staff will discuss the reasons with you. 
 
It is important to recognize that email is not secure. Email data can be stolen as it travels over the network and could be stored on 
mail servers, internet mail relays, as well as end devices. If, at any point, you feel unsafe or choose to no longer communicate on 
this platform, please email the student investigator and they will withdraw you from further study procedures and protocols. You 
will receive a copy of this letter of information and signed Informed Consent. 
 
PUBLICATION OF RESULTS 
 
Results of this study may be published in professional journals and presented at conferences. Feedback about this study will be 
available approximately 6 months after the completion of the study. If you wish to receive the results of the study, please provide 
either your email or mailing address:   
 
 
CONTACT INFORMATION 
 
If you have any questions about your rights as a research participant or the conduct of this study, you may contact The Office of 
Human Research Ethics (519) 661-3036, 1-844-720-9816, email: ethics@uwo.ca. The REB is a group of people who oversee the 
ethical conduct of research studies. The HSREB is not part of the study team. Everything that you discuss will be kept 
confidential. Thank you for your assistance in this project. Please keep a copy of this form for your records. 

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CONSENT FORM 
 
Study Title: Information Interventions to Reduce Vaping in a Student Population 
 
This study has been explained to me and any questions I had have been answered. 
I know that I may leave the study at any time. I agree to take part in this study. 
 
 
 
 
 
Print Name of Participant 
Signature 
Date (DD-MM-YYYY) 
 
 
 
 
 
Name of Person Obtaining Consent 
Signature 
Date (DD-MM-YYYY)