Trial Title:
Effectiveness of a PMT Intervention to Reduce Alcohol in Young Adults
NCT ID:
NCT06615648
Condition:
Behavior, Drinking
Alcohol Drinking
Colorectal Cancer Control and Prevention
Healthy Volunteers
Conditions: Official terms:
Colorectal Neoplasms
Alcohol Drinking
Drinking Behavior
Conditions: Keywords:
Protection Motivation Theory
Alcohol
Alcohol Intention
Alcohol Behaviour
Colorectal Cancer
Behaviour Change
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
PMT
Description:
7-minute PMT intervention video
Arm group label:
PMT Information
Intervention type:
Behavioral
Intervention name:
Non-contact Control
Description:
6-minute alternative video
Arm group label:
Non-contact Control
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.
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.
Criteria for eligibility:
Criteria:
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:
- 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
Gender:
All
Minimum age:
19 Years
Maximum age:
25 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Western University
Address:
City:
London
Zip:
N6A3K7
Country:
Canada
Start date:
November 1, 2024
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Western University, Canada
Agency class:
Other
Source:
Western University, Canada
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06615648
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6876515/
https://journals-scholarsportal-info.proxy1.lib.uwo.ca/pdf/1359107x/v20i0004/688_eoanmsifrsac.xml_en
https://www.yalemedicine.org/news/colorectal-cancer-in-young-people
https://open.ncl.ac.uk/theories/10/protection-motivation-theory/
https://www.cancer.gov/about-cancer/causes-prevention/risk/alcohol/alcohol-fact-sheet
