Information Interventions to Reduce Vaping in a Student Population
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|ClinicalTrials.gov Identifier: NCT04982978|
Recruitment Status : Completed
First Posted : July 29, 2021
Last Update Posted : August 11, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Vaping Related Disorder||Behavioral: PMT Threat Appraisal Behavioral: General Nutrition and Lifestyle||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomly divided into one of two blocks (A or B), each containing a maximum of 75 participants (PMT present intervention group or the control group). The PMT present group will include an 8-minute informational video that explains the current research and health risks associated with vaping, within the context of a threat appraisal focus (Perceived Vulnerability and Perceived Severity). The PMT absent group (control group) will feature an 8-minute nutrition and lifestyle information video as an attention control strategy in this study. During this video intervention, the general risks and benefits of nutrition and lifestyle choices will be presented.|
|Masking Description:||Participants will be allocated to one of two experimental groups using a blocked randomization method; participants will be randomized within blocks such that an equal number are assigned to each treatment. Once participants are allocated to one block, each participant will then be assigned an ID number that will represent their block as well as their individual participant ID number (i.e., Participant '100-123' would be in the same group as participant '100-124'). At Day 7 (T1), participants in each group will be emailed their respective intervention video links. Participants will not be given any information regarding group allocation or additional intervention information until the Letter of Study End notification is sent out to private email accounts of participants.|
|Official Title:||The Effectiveness of the Protection Motivation Theory in Reducing Vaping Behaviour in a Student Population|
|Actual Study Start Date :||January 7, 2021|
|Actual Primary Completion Date :||May 1, 2021|
|Actual Study Completion Date :||May 1, 2021|
Active Comparator: PMT Threat Appraisal
The PMT present group will include an 8-minute informational video that explains the current research and health risks associated with vaping, within the context of a threat appraisal focus (Perceived Vulnerability and Perceived Severity). During this video intervention, the severity and vulnerability of vaping among young adults, both in the short and long-term health effects will be presented. In addition, the video will explain the negative impact of vaping and focus the attention of the participants on the lack of research and information that currently exists on popular vaping products and the potentially devastating impact it can have on the health of young adult populations.
Behavioral: PMT Threat Appraisal
The first half of the PMT present video will include narration by "Science Insider" producer, Benji Jones, including dialogue regarding the risks associated with vaping by Chief Pediatric Pulmonology at the NYU Winthrop Hospital, Dr. Melodi Pirzada, and information on nicotine by the Director of Pediatric Pulmonology at NYU's Langone Hassenfeld Children's Hospital, Dr. Mikhail Kazachkov. The second half of the PMT present video will include personal experiences and narratives by students at the University of Utah with information regarding our current knowledge of vaping health effects through research by Dr. Sean Maddock and Dr. Sean Callahan from the University of Utah to highlight the susceptibility of vaping for a population of young adults in university.
Sham Comparator: Nutrition and Lifestyle Control
The PMT absent group will feature an 8-minute nutritional information video as an attention control strategy titled, "Vaping Health Effects". During this video intervention, the general risks and benefits of nutrition and lifestyle will be presented. The focus of this video will be on how a balanced diet and proper lifestyle choices (i.e., adequate sleep, diet, etc.) can benefit the participants lives in the short-term and long-term.
Behavioral: General Nutrition and Lifestyle
The first half of the PMT absent video will be presented by the Alliance for Aging Research, including an immersive video design, explaining the impact that nutrition may have as the participants age, reviewed by Dr. Steven Austad and Senior Nutritionist Johanna Dwyer. The second half of the PMT absent video will be presented by TED-Ed with narration by Addison Anderson, including a similar immersive video design, explaining how the food the participants eat may affect our brain and overall health. The nutrition and lifestyle information design will be administered as a control because it provides informative lifestyle choices regarding nutrition that can help promote the participants overall health without having an underlying link to vaping behaviour and its subsequent effect on the status of health.
- Effect of Threat Appraisal on Vaping Intention [ Time Frame: 6-weeks ]Vaping intention was measured at each time-point (baseline (Day 0), T1 (Day 7), T2 (Day 30), T3 (Day 45)) using the threat appraisal Protection Motivation Theory (PMT) questionnaire to assess individuals' relative and immediate feelings about vaping before and after intervention over the 6-week follow-up periods, reporting a score on a scale between 1 and 10, 1 representing a low perceived threat outcome and 10 illustrating a high perceived threat outcome. Threat appraisals within PMT also identified Perceived Vulnerability (PV) and Perceived Severity (PS) of individual participants at each phase of the study protocol in order to assess delayed and processed fear associated with vaping devices, following the intervention. The primary hypothesis is those exposed to the threat appraisal information grounded in the PMT components of severity and vulnerability will score higher on purpose-built questions reflecting these components than their attentional information control counterparts.
- Effect of Perceived Vulnerability on Intention [ Time Frame: 6-weeks ]Reduction in intentions to vape were dependent on the extent to which individual participants experienced the intervention information. Perceived Vulnerability (PV) questions identified in the Protection Motivation Theory (PMT) questionnaire include items that question the individual participants' experience of their respective videos. Reporting was scored on a scale between 1 and 10, 1 representing a low intention and 10 a high intention to reduce vaping. These appreciations will indicate the power between inter-correlated vulnerability and severity, separately. Greater significance in vaping intention will be cross-examined to determine the influence of PV, independently. The secondary hypothesis is that those exposed to the threat appraisal information grounded in the PMT components of severity and vulnerability will show lower intentions to vape and lower vaping use compared to their attentional information (nutrition and lifestyle information group) control counterpart.
- Effect of Perceived Severity on Intention [ Time Frame: 6-weeks ]Reduction in intentions to vape were dependent on the extent to which participants experienced the intervention information. Perceived Severity (PS) questions identified in the Protection Motivation Theory (PMT) questionnaire included items that questioned the participants' experiences of their respective videos. Reporting was scored on a scale between 1 and 10, 1 representing a low intention and 10 a high intention to reduce vaping. These appreciations will indicate the power between inter-correlated vulnerability and severity, separately. Greater vaping intention will be cross-examined to determine the influence of PS, independently. In conjunction with perceived vulnerability, the secondary hypothesis is that those exposed to the threat appraisal information grounded in the PMT components of severity and vulnerability will show lower intentions to vape and lower vaping use compared to their attentional information (nutrition and lifestyle information group) control counterpart.
- Effect of intention on Behaviour Outcome [ Time Frame: 6-weeks ]Participant vaping behaviour was assessed at each timepoint (Day 0), T1 (Day 7), T2 (Day 30), T3 (Day 45)) using the Youth Vaping Questionnaire (YVQ) to assess how changes in intention to vape less translated to subsequent vaping behaviour patterns. The corroboration between intentions to vape less and reduced vaping behaviours were measured using one, five-point item, at each time-point during the six-week timeframe. Reporting was scored on a scale between 1 and 5,1 representing a low behaviour rate and 5 illustrating a high behaviour rate. The tertiary hypothesis is that reduction in intentions to vape will be associated with lower vaping use.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Provision of signed and dated informed consent form
- Ability to read and understand English
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Males and females; Age 18 years and older
- Self-report as current users of vaping products (>3x in the past 30 days)
- Willingness to adhere to the study intervention regimen
- Enrolled full-time within a registered Canadian university during the 2020-2021 school year
- Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access)
- Willingness to stop (or at least decrease the frequency of) vaping
- Activity restrictions that limit one's ability to engage in questionnaire testing
- Currently practicing in behaviour therapy treatment specific to vaping or attending a rehab centre
- At the time of signing/submitting this consent form the participants are under the legal age of 18
- Failure to complete and submit completed questionnaires within the 7-day study timeframe, starting the day that set of surveys is emailed to the participants by the student investigator
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04982978
|London, Ontario, Canada, N6A 3K7|
|Principal Investigator:||Harry Prapavessi, Ph.D||Professor|
Documents provided by Harry Prapavessis, PhD, Western University:
|Responsible Party:||Harry Prapavessis, PhD, Principal Investigator, Western University|
|Other Study ID Numbers:||
|First Posted:||July 29, 2021 Key Record Dates|
|Last Update Posted:||August 11, 2021|
|Last Verified:||August 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||Identifiable data will only be stored on the Personal Vault OneDrive data storage, using BitLocker-encryption for security. Because the research team is using an electronic safety/security system for data storage, following the 7 year retainment period, data will be destroyed by selecting the folders with any identifiable material and deleting them. Next, the student investigator will permanently delete the folders from the recycle bin of the OneDrive system to remove any opportunity of data retrieval.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Protection Motivation Theory