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Vaping Related DisorderNCT04982978

Information Interventions to Reduce Vaping in a Student Population

A study testing PMT Threat Appraisal and General Nutrition and Lifestyle in people with Vaping Related Disorder, run by Western University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Vaping Related Disorder
What is being tested?
PMT Threat Appraisal and General Nutrition and Lifestyle
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
77 participants
Where
1 siteCanada
Study dates
7 Jan 2021to 1 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Western University

    London, Ontario, N6A 3K7

Other trials in Canada

About this study

Official title: The Effectiveness of the Protection Motivation Theory in Reducing Vaping Behaviour in a Student Population

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. Allocation proceeds by randomly selecting one of the orderings and assigning the next block of participants to study groups according to the specific sequence. Once participants are allocated to one block, each block will be randomly assigned to one of the two interventions. Participants will be randomly divided into one of two blocks, each containing a maximum of 75 participants. Possible treatment allocations within each block are (1) AABB, (2) BBAA, (3) ABAB, etc. This method ensures equal treatment allocation within each block. Each participant will then be assigned a number that will represent the participants' block as well as the participants' individual participant ID number (i.e., Participant '100-123' would be in the same group as participant '100-124'). Groups will be assigned using an Excel file to input participants into subsequent groupings and keep track of questionnaire submissions. At baseline, purpose-questionnaires will be distributed to both groups to assess history and experience with vaping and measure intention to vape less along with the "baseline self-reported questionnaires" that will be administered on Day 1 to all participants. At Day 7 (T1), respective participants will be emailed the attached video link and questionnaires and be instructed to complete the surveys after watching the participants' respective videos. The study intervention will be a single site trial delivered as a video link to the email provided by the participant; both intervention videos will play on YouTube and participants will be instructed to complete the surveys immediately after watching the video attached to the email sent to the participants. The participants will complete self-reported questionnaires at 3 follow-up periods after baseline in the 6-week protocol (all questionnaires will be sent by the student investigator (SI) to the email provided by the participants). Self-reported vaping behaviour questionnaires will be managed at baseline, Day 7 (T1), Day 30 (T2), and Day 45 (T3).

Read the detailed 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. Allocation proceeds by randomly selecting one of the orderings and assigning the next block of participants to study groups according to the specific sequence. Once participants are allocated to one block, each block will be randomly assigned to one of the two interventions. Participants will be randomly divided into one of two blocks (A or B), each containing a maximum of 75 participants. Possible treatment allocations within each block are (1) AABB, (2) BBAA, (3) ABAB, etc. This method ensures equal treatment allocation within each block. Each participant will then be assigned an ID number that will represent the participants' block as well as the participants' individual participant ID number (i.e., Participant '100-123' would be in the same group as participant '100-124'). Participants will be provided the participants' ID number via email by the SI when the LOI/C is signed by the study team and sent back to the participant. Groups will be randomly allocated to an intervention group and an Excel file will be used to organize participants into subsequent groupings and keep track of questionnaire submissions. Since the total number of participants is 150, the investigators chose the block randomization method to assign groups equally because it is short enough to prevent imbalance and long enough to prevent guessing allocation in trials. Within the study timeline, the investigators plan to implement the block randomization schema following pre-screening and informed consent processing. To avoid the presence of stratification errors the investigators further plan to review the allocation design before administering study intervention and purpose-questionnaires to prevent participant mismanagement during the protocol. At baseline, purpose-questionnaires will be distributed to both groups to assess the participants' history and experience with vaping and measure the participants' intention to vape less along with the "baseline self-reported questionnaires" that will be administered on Day 1 to all participants. At Day 7 (T1), respective participants will be emailed an attached video link and the questionnaires and be instructed to complete the surveys immediately after watching the video. The study intervention will be a single site trial delivered as a video link to the email provided by the participant; both intervention videos will play on YouTube. The participants will complete self-reported questionnaires at 3 follow-up periods after baseline in the 6-week protocol (all questionnaires will be sent by the student investigator (SI) to the email provided by the participants). Self-reported vaping behaviour questionnaires will be managed at baseline, Day 7 (T1), Day 30 (T2), and Day 45 (T3). All interventions will be created using the Qualtrics Survey Software and will be distributed to the email provided by the individual participants.

The Protection motivation theory is a theory that helps to clarify fear appeals. The protection motivation theory proposes that the participants choose to commit to certain behaviours for self-protection based on four factors: the perceived severity of a threatening event, the perceived probability of the occurrence, or vulnerability, the efficacy of the recommended preventive behaviour, and the perceived self-efficacy. Within the study design, participant groups are one of two treatment conditions: PMT present or PMT absent (attention control). 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 of vaping among young adult populations, incorporating both the short and long-term health effects will be presented. In addition, the negative impact of vaping and the lack of research and information that currently exists on popular vaping products will be brought to light, including the potentially devastating impact it can have on the health of young adults. The PMT absent 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. The focus of this video will be on how a balanced diet and proper lifestyle choices (i.e., adequate sleep) can benefit the participants lives in the short-term and long-term. In regard to lifestyle choices, the topic of substance abuse will be discussed briefly but without depth or research. The reason for the nutrition and lifestyle information group control intervention is because it provides informative lifestyle choices that can help promote the participants overall health without having an underlying link to vaping behaviour, separating and illustrating the impact of the specific information provided by the threat appraisal PMT, compared to general nutrition and lifestyle advice on overall vaping intention and behaviour of a Canadian student population of mostly young adults. Within the study procedures, the investigators acknowledge the potential impact retrospective questionnaires may have on participants; in the study design the investigators expect there to be a change in intention to vape as a result of the intervention, specifically in the PMT group, however, the investigators do not expect the questionnaires alone to cause statistically significant change to participant behaviour-intention or action-behaviour.

If the Principal Investigator (PI) and Student Investigator (SI) determine safe behaviour is not being practiced and/or the participant is not in a stable psychological state, the SI will email the respective participant(s) privately and explain that the participants should only continue to participate in this study if the participants feel safe and psychologically sound. The contact information of a clinical psychologist, Dr. Lisa Lee, and the Counselling Service of London, specialized in anxiety therapy and self-esteem counselling, both as part of the study team, will be included in this email or provided to participants upon request, along with the Center for Addiction and Mental Health (CAMH) distress phone number. The role of Dr. Lee and the Counselling Service of London are to work as a mental health resource for participants in cases that the PI and SI deem the participant is not practicing safe behaviour/in a stable psychological state and in circumstances where the participant requests additional aid from the study team. All participants will also be reminded to contact the participants' respective university health centre resources. In extreme cases, if the SI and PI recognize a participant is continuing to not practice safe behaviour or maintain a stable psychological state, the participant will be withdrawn from study participation and the contact information for Dr. Lee, the Counselling Services of London, and the CAMH distress line will be provided to the participant again, advising the participants to call, email, or text the health and wellness centre for additional aid.

Being tested
PMT Threat Appraisal, General Nutrition and Lifestyle
Keywords
Protection Motivation Theory, Threat Appraisal, Health Psychology, Intention, Behaviour
Medical subject headings
Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PMT Threat AppraisalBehavioural

    Also called Threat Appraisal, Health Threat Information

    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.

  • General Nutrition and LifestyleBehavioural

    Also called Attention Control, 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.

Study groups in NCT04982978
Study groupRoleWhat they receive
PMT Threat AppraisalActive comparatorThe 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.
Receives: Behavioral: PMT Threat Appraisal
Nutrition and Lifestyle ControlSham comparatorThe 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.
Receives: Behavioral: General Nutrition and Lifestyle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of Threat Appraisal on Vaping Intention

    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.

    Measured: 6-weeks

Secondary outcomes (2)
  1. Effect of Perceived Vulnerability on Intention

    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.

    Measured: 6-weeks

  2. Effect of Perceived Severity on Intention

    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.

    Measured: 6-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2021
  2. Study start7 Jan 2021
  3. Primary completion1 May 2021
  4. Study completion1 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Participant
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04982978
Sponsor's protocol ID
116734
Status last verified
Aug 2021
First submitted
23 Jun 2021
Last updated
11 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Azagba S. E-cigarette use, dual use of e-cigarettes and tobacco cigarettes, and frequency of cannabis use among high school students. Addict Behav. 2018 Apr;79:166-170. doi: 10.1016/j.addbeh.2017.12.028. Epub 2017 Dec 23.

    PubMed 29291507
  • Bein K, Leikauf GD. Acrolein - a pulmonary hazard. Mol Nutr Food Res. 2011 Sep;55(9):1342-60. doi: 10.1002/mnfr.201100279.

    PubMed 21994168
  • Bell K, Keane H. Nicotine control: E-cigarettes, smoking and addiction. Int J Drug Policy. 2012 May;23(3):242-7. doi: 10.1016/j.drugpo.2012.01.006. Epub 2012 Feb 23.

    PubMed 22365155
  • Besaratinia A, Tommasi S. Vaping: A growing global health concern. EClinicalMedicine. 2019 Nov 16;17:100208. doi: 10.1016/j.eclinm.2019.10.019. eCollection 2019 Dec. No abstract available.

    PubMed 31891141
  • Boakye E, Obisesan OH, Osei AD, Dzaye O, Uddin SMI, Hirsch GA, Blaha MJ. The Promise and Peril of Vaping. Curr Cardiol Rep. 2020 Oct 9;22(12):155. doi: 10.1007/s11886-020-01414-x.

    PubMed 33037523
  • Callahan-Lyon P. Electronic cigarettes: human health effects. Tob Control. 2014 May;23 Suppl 2(Suppl 2):ii36-40. doi: 10.1136/tobaccocontrol-2013-051470.

    PubMed 24732161
  • Chadi N, Schroeder R, Jensen JW, Levy S. Association Between Electronic Cigarette Use and Marijuana Use Among Adolescents and Young Adults: A Systematic Review and Meta-analysis. JAMA Pediatr. 2019 Oct 1;173(10):e192574. doi: 10.1001/jamapediatrics.2019.2574. Epub 2019 Oct 7.

    PubMed 31403684
  • Cole AG, Aleyan S, Battista K, Leatherdale ST. Correction to: Trends in youth e-cigarette and cigarette use between 2013 and 2019: insights from repeat cross-sectional data from the COMPASS study. Can J Public Health. 2021 Feb;112(1):70. doi: 10.17269/s41997-020-00441-z. No abstract available.

    PubMed 33174129
  • Czoli CD, Hammond D, White CM. Electronic cigarettes in Canada: prevalence of use and perceptions among youth and young adults. Can J Public Health. 2014 Feb 3;105(2):e97-e102. doi: 10.17269/cjph.105.4119.

    PubMed 24886856
  • Darabseh MZ, Selfe J, Morse CI, Degens H. Is vaping better than smoking for cardiorespiratory and muscle function? Multidiscip Respir Med. 2020 Jul 3;15(1):674. doi: 10.4081/mrm.2020.674. eCollection 2020 Jan 28.

    PubMed 32670575
  • Droulers O, Gallopel-Morvan K, Lacoste-Badie S, Lajante M. The influence of threatening visual warnings on tobacco packaging: Measuring the impact of threat level, image size, and type of pack through psychophysiological and self-report methods. PLoS One. 2017 Sep 14;12(9):e0184415. doi: 10.1371/journal.pone.0184415. eCollection 2017.

    PubMed 28910317
  • Fataar F, Hammond D. The Prevalence of Vaping and Smoking as Modes of Delivery for Nicotine and Cannabis among Youth in Canada, England and the United States. Int J Environ Res Public Health. 2019 Oct 25;16(21):4111. doi: 10.3390/ijerph16214111.

    PubMed 31731420
  • Gaston A, Prapavessis H. Using a combined protection motivation theory and health action process approach intervention to promote exercise during pregnancy. J Behav Med. 2014 Apr;37(2):173-84. doi: 10.1007/s10865-012-9477-2. Epub 2012 Nov 23.

    PubMed 23180287
  • Gay B, Field Z, Patel S, Alvarez RM, Nasser W, Madruga M, Carlan SJ. Vaping-Induced Lung Injury: A Case of Lipoid Pneumonia Associated with E-Cigarettes Containing Cannabis. Case Rep Pulmonol. 2020 Apr 3;2020:7151834. doi: 10.1155/2020/7151834. eCollection 2020.

    PubMed 32309002
  • Giovino GA, Mirza SA, Samet JM, Gupta PC, Jarvis MJ, Bhala N, Peto R, Zatonski W, Hsia J, Morton J, Palipudi KM, Asma S; GATS Collaborative Group. Tobacco use in 3 billion individuals from 16 countries: an analysis of nationally representative cross-sectional household surveys. Lancet. 2012 Aug 18;380(9842):668-79. doi: 10.1016/S0140-6736(12)61085-X.

    PubMed 22901888

Questions about this trial

What is this clinical trial studying?

A study testing PMT Threat Appraisal and General Nutrition and Lifestyle in people with Vaping Related Disorder, run by Western University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of Threat Appraisal on Vaping Intention (time frame: 6-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04982978, which also lists 57 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.

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