ClinicalTrials.gg
Not yet recruitingNCT06615648Updated Sep 26, 2024

Effectiveness of a PMT Intervention to Reduce Alcohol in Young Adults

An interventional study of PMT and Non-contact Control in Behavior, Drinking, Alcohol Drinking and Colorectal Cancer Control and Prevention, sponsored by Western University, Canada. Not yet recruiting at 1 site in Canada. Open to participants aged 19 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-26.

Primary conditionAlcohol DrinkingRegistry: Drinking BehaviorReclassifiedWhy we changed it
Registry
Drinking Behavior — the first condition term the registry derived for this study.
ClinicalTrials.gg
Alcohol Drinking
Why
  1. The study's listed conditions name Alcohol Drinking, a narrower term within Drinking Behavior.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Western University, Canada · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
19 Years to 25 Years
Sex
All
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Study summary

This study will examine the effectiveness of a 7-minute informational video using the threat and coping components of the Protection Motivation Theory (PMT) reduces alcohol intention and behaviour among young Canadian adults. Our aim is to determine whether perceived vulnerability, perceived severity, response efficacy and self-efficacy are associated with goal intentions to reduce drinking alcohol, and whether goals intentions to reduce alcohol drinking are associated with actual reductions in alcohol use among this population. Participants will be randomized to view either a specific PMT-video or a non-specific video on coffee and then complete questionnaires that relate to the PMT constructs. Intention and behaviour to drink alcohol will be compared between the two conditions over a 4-week period.

Read the detailed description

According to Statistics Canada, over three-quarters of Canadians drink alcohol, with those aged 20 to 24 being the most likely to report drinking alcohol. The National Cancer Institute reports that there is strong evidence that alcohol drinking can cause several types of cancers and the consumption of alcoholic beverages is recognized as a known human carcinogen. The evidence shows that increased alcohol consumption, especially regular drinking over time, elevates the risk of developing alcohol-related cancers. Clear patterns have emerged between alcohol consumption and the development of colorectal cancer, with cases increasing particularly in young adults. With rising cases of alcohol-related cancers, particularly colorectal cancer in younger adults, and the widespread prevalence of alcohol consumption among this age group, this demographic becomes an important focus for preventative health strategies including targeted research and interventions. Therefore, the objective of the present study is to assess the effectiveness of an intervention grounded in the Protection Motivation Theory (PMT) to reduce alcohol-related intentions and behaviours among young Canadian adults. This study will provide valuable insights into young adults\' drinking patterns and cancer awareness while supporting the development of effective interventions for reducing alcohol-related cancer risks in this vulnerable population. If the proposed intervention is successful, it can guide young adults into creating healthier habits and reduce the incidence and prevalence of colorectal cancer. Protection Motivation Theory (PMT) was introduced to explain the impact of persuasive communication on behaviour, with an emphasis on cognitive mechanisms underpinning the rationale to follow or not to follow a recommended behaviour. The framework outlines how threat and coping appraisals predict behavioural intentions, which then predict behaviour. Understanding the role that perceived vulnerability, perceived severity, response efficacy and self-efficacy of the PMT model play in affecting health behaviour change will help public health educators understand how to develop specific interventions to inform this population about the relationship between colorectal cancer and alcohol and enact positive change in the decision-making related to alcohol drinking.

This study will be a two-armed randomized control trial (RCT) with repeated measures (i.e., baseline, post-intervention, and 4-week follow-up). Participants will be randomly allocated to treatment groups using block randomization and a random number generator to place participants in groups of two (intervention and attention control). The block randomization method will be conducted following the Student Investigator (SI) acquiring consent and the LOI form. Participants will then be provided with their specific study number via email. Participants will be recruited through a variety of avenues: through the Mass Recruitment system at Western University, through Facebook groups, and presentations at university club meetings and classes. Posters will be displayed across the Western campus and London and lastly through informal conversation between peers. All recruitment aids will inform the interested participant to contact the SI to receive the information letter. The PMT intervention group will be given a video podcast relating to the threat and coping appraisal components of PMT (perceived severity, perceived vulnerability, response-efficacy and self-efficacy) and include information pertaining to alcohol and its correlation to colorectal cancer. The attention control group will also be given a video podcast, however, this video will focus on general information about coffee instead of specific alcohol and colorectal cancer information. This study will be conducted entirely online, with no in-person components for participants. Upon enrollment, participants will be provided with a Letter of Information (LOI) to review, electronically sign, and submit via email. At baseline, participants will be required to complete a series of surveys that assess their drinking patterns, drinking intentions, Protection Motivation Theory (PMT) constructs, and demographic information via Qualtrics. After submitting this baseline data, one week later, participants will receive a podcast video link via YouTube. The PMT intervention video podcast will be created using iMovie on MacOS and will be a 7-minute informational video explaining the current research on alcohol and its relationship to colorectal cancer and colorectal cancer risks associated with alcohol. This will be within the context of both the threat and coping appraisals of the PMT that highlights the severity of colorectal cancer, the susceptibility of colorectal cancer and the efficacy of a coping response to reduce alcohol consumption., while those in the attentional-control group will receive general information about coffee. Following the video, participants will be asked to immediately complete surveys on the PMT constructs and their alcohol-related intentions. At the final time point, 4 weeks post-intervention, participants will be asked to complete the same surveys again, including those assessing PMT, intentions, and actual drinking behaviour. All study materials, including links to the surveys, will be sent to participants via the email address they provided at the start of the study to the SI.

The primary objectives of this study are to investigate whether the use of an informational video linking alcohol use and colorectal cancer, following the threat and coping appraisal components of the Protection Motivation Theory (PMT) framework, reduces alcohol drinking intention and behaviour among young Canadian adults. Additionally, we are aiming to determine whether perceived vulnerability, perceived severity, response efficacy and self-efficacy are associated with goal intentions to reduce drinking alcohol and whether goals intentions to reduce drinking alcohol are associated with actual reductions in alcohol use. Threat and coping appraisals, goal intention and behaviour will be assessed using online self-report questionnaires at baseline, immediately post-intervention and 4 weeks through Qualtrics. We hypothesize that those exposed to the threat and coping appraisal information grounded in the PMT components of severity, vulnerability, response efficacy, and self-efficacy will achieve higher scores on purpose-built questions reflecting these components compared to their control counterparts focused on attentional information. We further hypothesize that those exposed to the threat and coping appraisal information grounded in the PMT components of severity, vulnerability, response efficacy and self-efficacy will show lower intentions to drink alcohol and lower alcohol use compared to their attentional information control counterparts. Finally, we hypothesize that increases in severity, vulnerability, response efficacy and self-efficacy of alcohol usage will be associated with a reduction in intentions to drink. Data collected throughout this study will be quantitative in nature and will be analyzed using a variety of statistical tests which could include t-tests, analysis of variance, correlation analyses, and multiple regression analyses. Descriptive statistics will be done and continuous data will be presented with standard deviation, mean, median and range. As data will be collected at multiple points throughout the study, a repeated measures analysis will be used to analyze the outcomes of variables at different points throughout the study. This will allow for the comparison between the intervention and control groups as the repeated measures correlation model tells us the strength of the linear correlation between the two groups.

02

Conditions studied

  • Behavior, Drinking
  • Alcohol Drinking
  • Colorectal Cancer Control and Prevention
  • Healthy Volunteers

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Keywords

  • Protection Motivation Theory
  • Alcohol
  • Alcohol Intention
  • Alcohol Behaviour
  • Colorectal Cancer
  • Behaviour Change
03

In context

Alcohol Drinking Reclassified

701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.

This study's planned enrollment of 152 is above the median of 122 across 607 interventional studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

Western University, Canada is the lead sponsor of 224 studies on the registry; 56 are open to participants now.

Compared within Alcohol Drinking, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Drinking Behavior. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
19 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 19-25 Able to read, write and understand English
  • Current alcohol drinker
  • Access to necessary resources for a technology-based intervention (i.e., smartphone, computer, internet)

Exclusion criteria

Exclusion Criteria:

  • Under the legal drinking age in Ontario of 19 at the time of signing the consent form
  • Currently actively participating in behaviour therapy treatment for alcohol or attending a rehab centre
  • Are pregnant /plan to become pregnant during the study period
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
152 participants (estimated)

Study arms

  • Experimental
    PMT Information

    The participant will watch the PMT-video and then complete the associated questionnaires.

    Behavioral: PMT

  • Active comparator
    Non-contact Control

    The participant will watch a non-specific video about coffee and then complete the associated questionnaires.

    Behavioral: Non-contact Control

Interventions

  • BehavioralPMT

    7-minute PMT intervention video

  • BehavioralNon-contact Control

    6-minute alternative video

06

What researchers measure

Primary outcomes

  1. Alcohol Intention

    Participants alcohol intentions measured using an online questionnaire.

    Time frame: From enrollment to the end of treatment at 4-weeks post-intervention.

  2. Alcohol Behaviour

    Participants alcohol consumption as measured using an online questionnaire.

    Time frame: From enrollment to the end of treatment at 4-weeks post-intervention.

07

Study locations

1 site
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2024; primary completion for Jan 2025, 2 months later.

Of 328 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 2 months is below that.

Counting every sponsor, half of 336 studies reached it within 24 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2024
First posted
Sep 26, 2024
StartEst.
Nov 1, 2024
Primary completionEst.
Jan 1, 2025
CompletionEst.
Mar 1, 2025
Last update
Sep 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06615648
Responsible party
Dr. Harry Prapavessis (Principle Investigator, Western University, Canada) — Principal investigator
First posted
Sep 26, 2024
Start date
Nov 1, 2024 (estimated)
Primary completion
Jan 1, 2025 (estimated)
Completion
Mar 1, 2025 (estimated)
Last update
Sep 26, 2024

Study contacts

Harry Prapavessis
Contact
hprapave@uwo.ca
5196612111 ext. 80173
Nicole S Moses
Contact
nmoses3@uwo.ca
6472140477
Harry Parapavessis
principal investigator · Western University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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