- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06762756
Impact of Positive Mental Vs. Physical Health Messaging on Motivation to Stop Smoking
What is the Effect of Presenting Evidence of the Mental Vs Physical Health Benefits of Quitting Smoking on Motivation to Stop Smoking? an Online Randomised Controlled Experiment
This study tested whether positive messages on tobacco packaging about the mental health benefits of quitting smoking could help motivate people to stop smoking. It compared three types of labels: ones focusing on mental health benefits, ones focusing on physical health benefits, and blank labels.
The experiment involved 631 people who smoke who were randomly shown one of these label types on an online survey platform. Participants' motivation to quit smoking was measured before and after viewing the labels.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bath, United Kingdom, BA2 7AY
- University of Bath
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Self-reported weekly tobacco smokers
- Aged at least 18 years
- Could read English
Exclusion Criteria:
Did not smoke tobacco at least weekly
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Positive mental health labels
Participants viewed four messages, formatted as tobacco packaging labels, communicating the benefits of smoking cessation for mental health. The messages were:
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The intervention was messages of the benefits of smoking cessation formatted as tobacco packaging labels with three conditions.
Participants viewed the messages online.
There were four messages in each condition.
The intervention was informed by relevant patient and public groups.
|
|
Active Comparator: Positive physical health labels
Participants viewed four messages, formatted as tobacco packaging labels, communicating the benefits of smoking cessation for physical health. The messages were:
|
The intervention was messages of the benefits of smoking cessation formatted as tobacco packaging labels with three conditions.
Participants viewed the messages online.
There were four messages in each condition.
The intervention was informed by relevant patient and public groups.
|
|
Placebo Comparator: Blank labels
Participants viewed four blank messages, formatted as tobacco packaging labels. The messages were:
|
The intervention was messages of the benefits of smoking cessation formatted as tobacco packaging labels with three conditions.
Participants viewed the messages online.
There were four messages in each condition.
The intervention was informed by relevant patient and public groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motivation to stop smoking
Time Frame: At baseline and follow up immediately after viewing the labels
|
Motivation to stop smoking was measured using the Motivation to Stop Scale (MTSS).
The MTSS asks participants "Which of the following best describes you?" with the following ordinal scale: 1) "I don't want to stop smoking"; 2) "I think I should stop smoking but don't really want to"; 3) "I want to stop smoking but haven't thought about when"; 4) "I REALLY want to stop smoking but I don't know when I will"; 5) "I want to stop smoking and hope to soon"; 6) "I REALLY want to stop smoking and intend to in the next 3 months"; 7) "I REALLY want to stop smoking and intend to in the next month".
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At baseline and follow up immediately after viewing the labels
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intention to Quit
Time Frame: Measured at baseline and follow up immediately after viewing the labels
|
Participants were asked their intention to quit smoking "Are you planning to quit smoking within the next month?"
using a 10-point visual analogue scale, where 1 indicates low intention to quit and 10 indicates higher intention to quit smoking
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Measured at baseline and follow up immediately after viewing the labels
|
|
Quitting Self-Efficacy
Time Frame: Measured at baseline and follow up immediately after viewing the labels
|
To measure participants' self-efficacy to quit smoking, participants responded to the questions "Overall, how confident are you that you can stop smoking within the next month?"
on a 5-point scale 1 ('not at all') to 5 ('completely confident') and "For me cutting down on the number of cigarettes that I smoke in the next month would be…."
On a scale off 1 ('very difficult') to 5 ('very easy').
The mean score across the two items was calculated, with a higher score indicating higher self-efficacy
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Measured at baseline and follow up immediately after viewing the labels
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Smoking Beliefs
Time Frame: Measured at baseline and follow up immediately after viewing the labels
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Participants rated their agreement to the statements "smoking helps people relax", "smoking helps to reduce stress", "smoking helps to keep weight down" "smoking increases social comfort" "those who smoke are more popular" and "second hand smoke is not harmful" using a 5-point scale from 1 ('not at all') to 5 ('a lot').
The mean score across the five items was calculated, with a higher score indicating more favourable beliefs towards smoking
|
Measured at baseline and follow up immediately after viewing the labels
|
|
Attention
Time Frame: Measured at follow up immediately after viewing the labels
|
Participants rated two statements 'these labels are worth remembering' and 'these labels grabbed my attention' on a 5-point scale from 1 ('not at all') to 5 ('a lot'), mean score across the two items was calculated, with a higher score indicating greater attention
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Measured at follow up immediately after viewing the labels
|
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Affective Reactions
Time Frame: Measured at follow up immediately after viewing the labels
|
To measure affective reactions to the health labels we used the Self-Assessment Manakin (SAM, (Bradley & Lang, 1994)).
Participants rated their affective reactions: valence, arousal, and dominance on a 9-point visual analogue scale.
Scales for valence range from 1 'unpleasant' to 9 'pleasant', arousal ranged from 1 'calm' to 9 'excited', and dominance ranged from 1 'controlled' to 9 'in control' with 5 as neutral for all items
|
Measured at follow up immediately after viewing the labels
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Believability
Time Frame: Measured at follow up immediately after viewing the labels
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Perceptions of believability of the health label were measured using the question "How believable are these health labels?",
participants rated this on a 5-point scale from 1 ('not at all') to 5 ('a lot')
|
Measured at follow up immediately after viewing the labels
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gemma Taylor, PhD, University of Bath
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 21-244
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Study Data/Documents
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Individual Participant Data Set
Information comments: The datasets generated and/or analysed during the current study are available in the University of Bath repository.
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Analytic Code
Information comments: Scripts are available on Open Science Framework
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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