NCT06762756

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
631

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

December 19, 2024

Last Update Submit

January 7, 2025

Conditions

Keywords

SmokingSmoking cessationPublic healthMental healthTobacco warning labels

Outcome Measures

Primary Outcomes (1)

  • 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".

    At baseline and follow up immediately after viewing the labels

Secondary Outcomes (6)

  • Intention to Quit

    Measured at baseline and follow up immediately after viewing the labels

  • Quitting Self-Efficacy

    Measured at baseline and follow up immediately after viewing the labels

  • Smoking Beliefs

    Measured at baseline and follow up immediately after viewing the labels

  • Attention

    Measured at follow up immediately after viewing the labels

  • Affective Reactions

    Measured at follow up immediately after viewing the labels

  • +1 more secondary outcomes

Study Arms (3)

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"

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"

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"

Behavioral: Messages on tobacco packaging labels

Interventions

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.

Blank labelsPositive mental health labelsPositive physical health labels

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-reported weekly tobacco smokers
  • Aged at least 18 years
  • Could read English

You may not qualify if:

  • Did not smoke tobacco at least weekly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bath

Bath, BA2 7AY, United Kingdom

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Tobacco SmokingSmokingSmoking CessationPsychological Well-Being

Condition Hierarchy (Ancestors)

BehaviorTobacco UseHealth BehaviorPersonal Satisfaction

Study Officials

  • Gemma Taylor, PhD

    University of Bath

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

December 19, 2024

First Posted

January 8, 2025

Study Start

September 1, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

January 9, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

The datasets generated and/or analysed during the current study are available in the University of Bath repository.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
Data will be available on publication and indefinitely
Access Criteria
Scripts are available at https://osf.io/v5deq/?view\ only=d5dd1f5903a0480d94402c7c6528c6a4

Available IPD Datasets

Individual Participant Data Set Access
Analytic Code Access

Locations