Smoking, TobaccoNCT06762756
Impact of Positive Mental Vs. Physical Health Messaging on Motivation to Stop Smoking
A study testing Messages on tobacco packaging labels in people with Smoking, Tobacco, run by Katherine Sawyer at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco
- What is being tested?
- Messages on tobacco packaging labels
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 631 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2022to 28 Feb 2023
- 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
- Self-reported weekly tobacco smokers
- Aged at least 18 years
- Could read English
Who cannot join
- Did not smoke tobacco at least weekly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Smoking, Tobacco
- Being tested
- Messages on tobacco packaging labels
- Keywords
- Smoking, Smoking cessation, Public health, Mental health, Tobacco warning labels
- Medical subject headings
- Tobacco Smoking, Smoking, Smoking Cessation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Messages on tobacco packaging labelsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Positive mental health labels | Experimental | Participants viewed four messages, formatted as tobacco packaging labels, communicating the benefits of smoking cessation for mental health. The messages were:
* "Quitting smoking improves your mental health"
* "Quitting smoking reduces feelings of depression"
* "Quitting smoking reduces feelings of anxiety"
* "Quitting smoking can improve your mood" Receives: Behavioral: Messages on tobacco packaging labels |
| Positive physical health labels | Active comparator | Participants viewed four messages, formatted as tobacco packaging labels, communicating the benefits of smoking cessation for physical health. The messages were:
* "Quitting smoking improves your health"
* "Quitting smoking reduces risk your risk of having a heart attack"
* "Quitting smoking reduces shortness of breath and coughing"
* "Quitting smoking can improve your oral health" Receives: Behavioral: Messages on tobacco packaging labels |
| Blank labels | Placebo comparator | Participants viewed four blank messages, formatted as tobacco packaging labels. The messages were:
* Blank template
* Template with "Example"
* Template with "Template"
* Template with "Image, Text" Receives: Behavioral: Messages on tobacco packaging labels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivation to stop smoking
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".
Measured: At baseline and follow up immediately after viewing the labels
Secondary outcomes (6)
Intention to Quit
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
Measured: Measured at baseline and follow up immediately after viewing the labels
Quitting Self-Efficacy
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
Measured: Measured at baseline and follow up immediately after viewing the labels
Smoking Beliefs
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: Measured at baseline and follow up immediately after viewing the labels
Attention
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
Measured: Measured at follow up immediately after viewing the labels
Affective Reactions
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: Measured at follow up immediately after viewing the labels
Believability
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: Measured at follow up immediately after viewing the labels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Sep 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking, TobaccoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention was tobacco warning labels with three conditions: i) positive mental health labels; ii) positive physical health labels; iii) blank labels. Participants were randomly allocated to one label condition using Qualtrics embedded randomisation function, stratified by mental health status, and viewed four labels for at least 10 seconds each.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 631 participants (actual)
Sponsor and investigators
- Lead sponsor
- Katherine Sawyer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katherine Sawyer, University of Bath
- Investigators
- Gemma Taylor, PhD, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762756
- Sponsor's protocol ID
- 21-244
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and/or analysed during the current study are available in the University of Bath repository.
Publications
Sawyer K, Hanafi A, Freeman TP, Burke C, Adams S, Aveyard P, Jacobsen P, Taylor G. 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. BMC Public Health. 2025 Jul 3;25(1):2331. doi: 10.1186/s12889-025-22795-0.
PubMed 40610984
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06762756
- Acronym / sponsor ID
- 21-244
- Conditions
- Smoking, Tobacco
- Keywords
- Smoking, Smoking cessation, Public health, Mental health, Tobacco warning labels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 631 participants (actual)
- Lead sponsor
- Katherine SawyerUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The intervention was tobacco warning labels with three conditions: i) positive mental health labels; ii) positive physical health labels; iii) blank labels. Participants were randomly allocated to one label condition using Qualtrics embedded randomisation function, stratified by mental health status, and viewed four labels for at least 10 seconds each.
| Arm | Type | Receives |
|---|---|---|
| Positive mental health labels | Experimental | Behavioral: Messages on tobacco packaging labelsParticipants viewed four messages, formatted as tobacco packaging labels, communicating the benefits of smoking cessation for mental health. The messages were: * "Quitting smoking improves your mental health" * "Quitting smoking reduces feelings of depression" * "Quitting smoking reduces feelings of anxiety" * "Quitting smoking can improve your mood" |
| Positive physical health labels | Active comparator | Behavioral: Messages on tobacco packaging labelsParticipants viewed four messages, formatted as tobacco packaging labels, communicating the benefits of smoking cessation for physical health. The messages were: * "Quitting smoking improves your health" * "Quitting smoking reduces risk your risk of having a heart attack" * "Quitting smoking reduces shortness of breath and coughing" * "Quitting smoking can improve your oral health" |
| Blank labels | Placebo comparator | Behavioral: Messages on tobacco packaging labelsParticipants viewed four blank messages, formatted as tobacco packaging labels. The messages were: * Blank template * Template with "Example" * Template with "Template" * Template with "Image, Text" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-reported weekly tobacco smokers
- Aged at least 18 years
- Could read English
Key exclusion criteria (1 listed)
- Did not smoke tobacco at least weekly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Messages on tobacco packaging labelsThe 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. | Behavioural | Blank labels, Positive mental health labels, Positive physical health labels |
Primary outcome
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".
6 secondary outcomes
Intention to Quit
Time frame: 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
Smoking Beliefs
Time frame: Measured at baseline and follow up immediately after viewing the labels
Attention
Time frame: Measured at follow up immediately after viewing the labels
Affective Reactions
Time frame: Measured at follow up immediately after viewing the labels
Believability
Time frame: Measured at follow up immediately after viewing the labels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Derived from this study: PubMed 40610984Sawyer K, Hanafi A, Freeman TP, Burke C, Adams S, Aveyard P, Jacobsen P, Taylor G. 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. BMC Public Health. 2025 Jul 3;25(1):2331. doi: 10.1186/s12889-025-22795-0.
- Pre-registered protocol on Open Science FrameworkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The datasets generated and/or analysed during the current study are available in the University of Bath repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gemma Taylor, PhD principal investigator
University of Bath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Messages on tobacco packaging labels in people with Smoking, Tobacco, run by Katherine Sawyer at 1 site in United Kingdom.
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 3 inclusion and 1 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 9 Jan 2025. 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 United Kingdom. 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?
Motivation to stop smoking (time frame: At baseline and follow up immediately after viewing the labels). 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 NCT06762756, which also lists 1 linked publication.
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 9 Jan 2025.