Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-01 @ 1:47 PM
Study NCT ID:
NCT06762756
Status:
COMPLETED
Last Update Posted:
2025-01-09
First Post:
2024-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Positive Mental Vs. Physical Health Messaging on Motivation to Stop Smoking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 631}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2025-01-06', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motivation to stop smoking', 'timeFrame': 'At baseline and follow up immediately after viewing the labels', 'description': '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".'}], 'secondaryOutcomes': [{'measure': 'Intention to Quit', 'timeFrame': 'Measured at baseline and follow up immediately after viewing the labels', 'description': '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'}, {'measure': 'Quitting Self-Efficacy', 'timeFrame': 'Measured at baseline and follow up immediately after viewing the labels', 'description': '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'}, {'measure': 'Smoking Beliefs', 'timeFrame': 'Measured at baseline and follow up immediately after viewing the labels', 'description': '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'}, {'measure': 'Attention', 'timeFrame': 'Measured at follow up immediately after viewing the labels', 'description': "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"}, {'measure': 'Affective Reactions', 'timeFrame': 'Measured at follow up immediately after viewing the labels', 'description': "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"}, {'measure': 'Believability', 'timeFrame': 'Measured at follow up immediately after viewing the labels', 'description': '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\')'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smoking', 'Smoking cessation', 'Public health', 'Mental health', 'Tobacco warning labels'], 'conditions': ['Smoking, Tobacco']}, 'referencesModule': {'availIpds': [{'url': 'https://researchdata.bath.ac.uk', 'type': 'Individual Participant Data Set', 'comment': 'The datasets generated and/or analysed during the current study are available in the University of Bath repository.'}, {'url': 'https://osf.io/v5deq/?view_only=d5dd1f5903a0480d94402c7c6528c6a4', 'type': 'Analytic Code', 'comment': 'Scripts are available on Open Science Framework'}], 'references': [{'pmid': '40610984', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.17605/OSF.IO/3C75J', 'label': 'Pre-registered protocol on Open Science Framework'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Self-reported weekly tobacco smokers\n2. Aged at least 18 years\n3. Could read English\n\nExclusion Criteria:\n\nDid not smoke tobacco at least weekly'}, 'identificationModule': {'nctId': 'NCT06762756', 'briefTitle': 'Impact of Positive Mental Vs. Physical Health Messaging on Motivation to Stop Smoking', 'organization': {'class': 'OTHER', 'fullName': 'University of Bath'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '21-244'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Positive mental health labels', 'description': 'Participants viewed four messages, formatted as tobacco packaging labels, communicating the benefits of smoking cessation for mental health. The messages were:\n\n* "Quitting smoking improves your mental health"\n* "Quitting smoking reduces feelings of depression"\n* "Quitting smoking reduces feelings of anxiety"\n* "Quitting smoking can improve your mood"', 'interventionNames': ['Behavioral: Messages on tobacco packaging labels']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Positive physical health labels', 'description': 'Participants viewed four messages, formatted as tobacco packaging labels, communicating the benefits of smoking cessation for physical health. The messages were:\n\n* "Quitting smoking improves your health"\n* "Quitting smoking reduces risk your risk of having a heart attack"\n* "Quitting smoking reduces shortness of breath and coughing"\n* "Quitting smoking can improve your oral health"', 'interventionNames': ['Behavioral: Messages on tobacco packaging labels']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Blank labels', 'description': 'Participants viewed four blank messages, formatted as tobacco packaging labels. The messages were:\n\n* Blank template\n* Template with "Example"\n* Template with "Template"\n* Template with "Image, Text"', 'interventionNames': ['Behavioral: Messages on tobacco packaging labels']}], 'interventions': [{'name': 'Messages on tobacco packaging labels', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Blank labels', 'Positive mental health labels', 'Positive physical health labels']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BA2 7AY', 'city': 'Bath', 'country': 'United Kingdom', 'facility': 'University of Bath', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}], 'overallOfficials': [{'name': 'Gemma Taylor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bath'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available on publication and indefinitely', 'ipdSharing': 'YES', 'description': 'The datasets generated and/or analysed during the current study are available in the University of Bath repository.', 'accessCriteria': 'Scripts are available at https://osf.io/v5deq/?view\\_only=d5dd1f5903a0480d94402c7c6528c6a4'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Katherine Sawyer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Katherine Sawyer', 'investigatorAffiliation': 'University of Bath'}}}}