Information Interventions to Reduce Vaping in a Student Population

NCT04982978 | Completed

• 1 other identifier: 116734
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Vaping Related Disorder

Keywords

Protection Motivation Theory; Threat Appraisal; Health Psychology; Intention; Behaviour

Outcome Measures

Primary Outcomes (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.

  6-weeks

Secondary Outcomes (2)

• Effect of Perceived Vulnerability on Intention

  6-weeks

• Effect of Perceived Severity on Intention

  6-weeks

Other Outcomes (1)

• Effect of intention on Behaviour Outcome

  6-weeks

Study Arms (2)

PMT Threat Appraisal

ACTIVE COMPARATOR

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

Nutrition and Lifestyle Control

SHAM COMPARATOR

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

Interventions

PMT Threat Appraisal BEHAVIORAL

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.

Also known as: Threat Appraisal, Health Threat Information

PMT Threat Appraisal

General Nutrition and Lifestyle BEHAVIORAL

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.

Also known as: Attention Control, Nutrition and Lifestyle

Nutrition and Lifestyle Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University: lead

Study Sites (1)

Western University

London, Ontario, N6A 3K7, Canada

Location

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Related Links

• Growth in Popularity of Vaping
• Trend of Vaping in North America
• International Vaping Statistics

MeSH Terms

Conditions

Behavior

Interventions

Nutritional Status

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Harry Prapavessi, Ph.D

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 29, 2021
• Study Start: January 7, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)