Smoking CessationNCT03749382
Testing Smoking Interventions in Women
A study testing AprilAge- facial morphing appearance based intervention for smoking in people with Smoking Cessation, run by Manchester Metropolitan University at 1 site in United Kingdom.
Trial summary
The study is a randomised controlled trial (RCT) designed to test two tailored conditions of an appearance-based intervention for smoking in female smokers, compared to a control group administered a general stop smoking intervention. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- AprilAge- facial morphing appearance based intervention for smoking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jan 2019to 20 Aug 2020
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Aged 18-55
- Smoke at least 1 cigarette a week
Who cannot join
- Non-smokers
- Self-reported appearance related mental health issue
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Smoking Interventions in Women
The study is a randomised controlled trial (RCT) designed to test two tailored conditions of an appearance-based intervention for smoking in female smokers, compared to a control group administered a general stop smoking intervention.
The intervention delivery is being tested to assess whether the level of physiological arousal evoked by the intervention and the instruction type has an influence on the outcome measures. To do this one condition will receive the intervention with a neutral instruction and the other the intervention with additional instructions, measures of physiological stress reactivity will be used to measure level of stress evoked by the intervention and delivery.
Read the detailed description
Background
Despite health-related smoking cessation campaigns, still one in five of adults in the UK smokes and it is estimated that half of all regular smokers will eventually die from smoking-related diseases. Innovative smoking cessation campaigns are needed to reach the remaining smoker population and prevent smoking-related diseases.
Smoking interventions have previously focused on smoking impact on health. However, besides health-related diseases, smoking causes aging effects to the skin and recent research suggests that smoking interventions based on threats to appearance may be more effective. Further research using an age-appearance facial morphing intervention for smoking, which shows women realistic images of the effects of smoking on their own face, research found that female smokers aged 18-34 reported increased motivation to quit after the intervention. Quantitative results from a randomised control trial support the interventions effectiveness .
The previous research on appearance-based interventions for smoking show promising results however these studies had report small sample sizes and differences in the age range of participants. Additionally, previous research has focused on the primary outcome measures of smoking including smoking cognitions, behaviours and CO readings and have not investigated further moderating variables such as, anxiety, depression, appearance orientation and stage of change.
In previous research participants have consistently reported a 'shock' reaction, and findings from a pilot and feasibility study (unpublished) suggest that this 'shock' reaction as measured by physiological reactivity to the intervention could mediate smoking outcomes. Therefore, the present research proposes to assess facial morphing intervention effectiveness in relation to individual's physiological shock reactions to viewing the morphed images and moderator variables in a large sample of women across a broad age range.
Objectives:
Primary Objectives- To assess effectiveness of an appearance-based intervention on smoking outcomes in a female population (18-55 years old) immediately after the intervention session and at 1, 3 and 6 months post intervention session. In addition to compare the results to that of a standard stop smoking intervention.
An additional primary objective will be to compare the primary outcome measures for both appearance-based intervention instruction conditions (neutral vs additional) immediately after the intervention and at 1, 3 and 6 months after to assess which instruction type is more effective in reducing smoking behaviour.
Other objectives-
- Investigate the mediating effects of physiological arousal [measured during the intervention by electro dermal activity and beats per a minute (BPM, derived from pulse rate)] on the intervention efficacy as measured by the primary and secondary outcome measures.
- Investigate the impact of moderating variables on the primary outcome measures.
Measures
Outcome measures -
- The primary outcomes will be smoking intentions measured pre, immediately after and at 1, 3 and 6 months post intervention.
- Secondary outcome measures will be smoking cognitions (attitudes, subjective norms and perceived behavioural control), nicotine dependence and self-reported smoking behaviour measured pre, immediately after and at 1, 3 and 6 month post the intervention.
Participants:
Current female smokers aged 18-55 will be recruited and randomised into one of three conditions. (1) Appearance-based intervention neutral, (2) Appearance-based intervention additional instructions, (3) Control general stop smoking intervention. Participants are eligible to take part if they are a female between the ages of 18-55 and that they smoke at least one cigarette a week. Participants are informed to withhold from taking part if they have any mental health issues that may be affected by appearance-based imagery.
Randomisation will be achieved through using SPSS (V25) to create two sets of randomisation one for participants over the age of 35 and another for women under the age 35 to allow an equal distribution of ages into each condition.
Protocol:
At the start of the intervention session participants will be asked to provide informed consent, immediately after electrodes and a light sensor will be placed on the participants non-dominant hand. Participants are then asked to fill in a self-report questionnaire including demographic questions and stress confounders, smoking behaviour, cognitions and quit attempts, levels of anxiety and depression, how much they consider their future consequences and how they view their appearance.
Participants in the two appearance-based interventions groups will then have a photo taken of their face and aged with the effects of smoking in a range of morphing sequences and then given a general stop smoking booklet alternatively participants allocated to the control condition will be asked to only read a general stop smoking intervention booklet. All three conditions will then be asked to provide carbon monoxide breath reading using a hand held battery operated device. The participants smoking cognitions and behaviours will then be measured again immediately and longer term at 1, 3 and 6 months post intervention.
Sample size calculation:
In a previous randomized controlled trial (RCT) on an appearance-based intervention for female smokers , 35 women were allocated to one of two conditions (control group or intervention) with a reported effect size of d=.63 for nicotine dependence at 4 weeks post-intervention. Based on previous research and to account for a 30% dropout at six-month follow up 50 participants per group is required in the current study. Additionally, an a priori power analysis has been conducted using GPower which supports the specified number of participants per group. Specifically, to obtain a medium effect of .25 and a power of .80 at alpha .05, a total sample of 158 is required (52 per group).
- Conditions
- Smoking Cessation
- Being tested
- AprilAge- facial morphing appearance based intervention for smoking
- Keywords
- Smoking, Tobacco, Cessation, Intervention
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprilAge- facial morphing appearance based intervention for smokingOther
Also called Appearance-based intervention, Appearance orientated intervention, Internet-based Photo aging intervention
Appearance-based intervention: The intervention is a software that ages an individual's face with and without the effects of smoking. Participants have their photo taken on a laptop webcam, they are then asked to report their age and ethnicity in order to calibrate the software, the participants picture is then matched to a stock image. The participants will see two images on the screen, on the left is there face aged without the effects of smoking and one the right aged with the effects of smoking. Participants will be led through a series of morphing sequences (1-5). In-between each of the morphing sequences (Morph1 to Morph5) the participant will be asked to comment on the differences they can see between the two images.
General stop smoking intervention: The General stop smoking intervention comes in the form of a NHS stop smoking information leaflet. The participants will be given the leaflet on a laptop screen and asked to read through the whole document.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Neutral instructions | Experimental | Appearance based intervention group delivered with neutral instructions from the investigator alongside general stop smoking intervention leaflet. Receives: Other: AprilAge- facial morphing appearance based intervention for smoking |
| Intervention Additional instructions | Experimental | Appearance based intervention group delivered with neutral instructions with additional reassuring messages from the investigator alongside general stop smoking intervention leaflet. Receives: Other: AprilAge- facial morphing appearance based intervention for smoking |
| Control | No intervention | Neutral task plus the general stop smoking intervention in the form of a leaflet, administered by the investigator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Smoking Intentions
Smoking Intentions, which are intentions the participant has to quit smoking are measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Three items are each asked on a 13-point scale producing a combined score between 0-39. The score from each individual item is then averaged together to create a total score for smoking intentions. The higher the averaged score the more intention the participant has to quit smoking.The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011).
Measured: Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
Secondary outcomes (5)
Change in Smoking Attitudes
Smoking Attitudes, is the attitude a participant has to smoking cessation, measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Four items are each asked on a 13-point scale producing a score between 0-52. Scores from individual items are then averaged together to create a total score for Smoking Attitudes. The higher the averaged score the more positive the participants attitude is to smoking cessation. The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011).
Measured: Measures obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
Change in Smoking Subjective Norms
Smoking Subjective Norms, is the perceived social pressure the participant feels to stop smoking, measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Three items are each asked on a 13-point scale producing a combined score between 0-39. Scores from each individual item is then averaged together to create a total score for Smoking Subjective Norms. The higher the averaged score the more the participants feels it socially acceptable to quit smoking .The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011).
Measured: Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
Change in Smoking Perceived Behavioural Control
Smoking Subjective Perceived Behavioural Control, is the Perceived Control the participant has over their own smoking behaviour, measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Four items are each asked on a 13-point scale producing a combined score between 0-52. Scores from each individual item is then averaged together to create a total score for Smoking Perceived Behavioural Control. The higher the averaged score the more control a participants feels they have over their own smoking behaviour. The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011).
Measured: Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
Change in Nicotine dependence
Nicotine dependence as measured by the Fagerstrom test for nicotine dependence (Heatherton et al.,1991) a validated instrument that determines the extent to which participants are physically addicted to nicotine. The measure includes six items that are summed to create a score between 0-10. Higher scores equate to a higher dependence to nicotine.
Measured: Measure obtained pre-intervention and again at 1, 3 and 6 months post-intervention.
Change in Self-reported smoking behaviour
Participants report the amount of cigarettes smoked each day for the week prior to each measurement time point, the cigarettes consumed on each day are summed to create a total cigarette consumption score for the week. The measure is administered to the participant as part of the Smoking Questionnaire (Grogan et al., 2011).
Measured: Measure obtained pre-intervention and again at 1, 3 and 6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start10 Jan 2019
- Primary completion20 Aug 2020
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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
- Parallel assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucy Walker, Manchester Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749382
- Sponsor's protocol ID
- 0245
- Status last verified
- Sep 2020
- First submitted
- 15 Nov 2018
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
PubMed 11832252Borrelli B, Mermelstein R. The role of weight concern and self-efficacy in smoking cessation and weight gain among smokers in a clinic-based cessation program. Addict Behav. 1998 Sep-Oct;23(5):609-22. doi: 10.1016/s0306-4603(98)00014-8.
PubMed 9768298Cash, T. F. (2016) 'Multidimensional Body-Self Relations Questionnaire (MBSRQ).' In Wade, T. (ed.) Encyclopedia of Feeding and Eating Disorders. Singapore: Springer Singapore, pp. 1-4.
DiClemente CC, Prochaska JO, Fairhurst SK, Velicer WF, Velasquez MM, Rossi JS. The process of smoking cessation: an analysis of precontemplation, contemplation, and preparation stages of change. J Consult Clin Psychol. 1991 Apr;59(2):295-304. doi: 10.1037//0022-006x.59.2.295.
PubMed 2030191Flett K, Clark-Carter D, Grogan S, Davey R. How effective are physical appearance interventions in changing smoking perceptions, attitudes and behaviours? A systematic review. Tob Control. 2013 Mar;22(2):74-9. doi: 10.1136/tobaccocontrol-2011-050236. Epub 2012 May 9.
PubMed 22573734Flett K, Grogan S, Clark-Carter D, Gough B, Conner M. Male smokers' experiences of an appearance-focused facial-ageing intervention. J Health Psychol. 2017 Mar;22(4):422-433. doi: 10.1177/1359105315603477. Epub 2016 Jul 10.
PubMed 26338489Grogan S, Flett K, Clark-Carter D, Gough B, Davey R, Richardson D, Rajaratnam G. Women smokers' experiences of an age-appearance anti-smoking intervention: a qualitative study. Br J Health Psychol. 2011 Nov;16(4):675-89. doi: 10.1348/2044-8287.002006. Epub 2010 Dec 6.
PubMed 21199543Grogan S, Flett K, Clark-Carter D, Conner M, Davey R, Richardson D, Rajaratnam G. A randomized controlled trial of an appearance-related smoking intervention. Health Psychol. 2011 Nov;30(6):805-9. doi: 10.1037/a0024745. Epub 2011 Jul 18.
PubMed 21767016Gupta SK. Intention-to-treat concept: A review. Perspect Clin Res. 2011 Jul;2(3):109-12. doi: 10.4103/2229-3485.83221.
PubMed 21897887Koh JS, Kang H, Choi SW, Kim HO. Cigarette smoking associated with premature facial wrinkling: image analysis of facial skin replicas. Int J Dermatol. 2002 Jan;41(1):21-7. doi: 10.1046/j.1365-4362.2002.01352.x.
PubMed 11895509Strathman, A., Gleicher, F., Boninger, D. S. and Edwards, C. S. (1994) 'The consideration of future consequences: Weighing immediate and distant outcomes of behavior.' Journal of Personality and Social Psychology, 66(4) pp. 742-752.
Walker L, Grogan S, Denovan A, Scholtens K, McMillan B, Conner M, Epton T, Armitage CJ, Cordero MI. An Age-Progression Intervention for Smoking Cessation: A Pilot Study Investigating the Influence of Two Sets of Instructions on Intervention Efficacy. Int J Behav Med. 2026 Feb;33(1):128-137. doi: 10.1007/s12529-024-10285-3. Epub 2024 May 9.
PubMed 38724879
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Smoking Interventions in Women
- ClinicalTrials.gov ID
- NCT03749382
- Acronym / sponsor ID
- 0245
- Conditions
- Smoking Cessation
- Keywords
- Smoking, Tobacco, Cessation, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Manchester Metropolitan UniversityUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 21 Nov 2018 (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.
The study is a randomised controlled trial (RCT) designed to test two tailored conditions of an appearance-based intervention for smoking in female smokers, compared to a control group administered a general stop smoking intervention.
The intervention delivery is being tested to assess whether the level of physiological arousal evoked by the intervention and the instruction type has an influence on the outcome measures. To do this one condition will receive the intervention with a neutral instruction and the other the intervention with additional instructions, measures of physiological stress reactivity will be used to measure level of stress evoked by the intervention and delivery.
Detailed description
Background
Despite health-related smoking cessation campaigns, still one in five of adults in the UK smokes and it is estimated that half of all regular smokers will eventually die from smoking-related diseases. Innovative smoking cessation campaigns are needed to reach the remaining smoker population and prevent smoking-related diseases.
Smoking interventions have previously focused on smoking impact on health. However, besides health-related diseases, smoking causes aging effects to the skin and recent research suggests that smoking interventions based on threats to appearance may be more effective. Further research using an age-appearance facial morphing intervention for smoking, which shows women realistic images of the effects of smoking on their own face, research found that female smokers aged 18-34 reported increased motivation to quit after the intervention. Quantitative results from a randomised control trial support the interventions effectiveness .
The previous research on appearance-based interventions for smoking show promising results however these studies had report small sample sizes and differences in the age range of participants. Additionally, previous research has focused on the primary outcome measures of smoking including smoking cognitions, behaviours and CO readings and have not investigated further moderating variables such as, anxiety, depression, appearance orientation and stage of change.
In previous research participants have consistently reported a 'shock' reaction, and findings from a pilot and feasibility study (unpublished) suggest that this 'shock' reaction as measured by physiological reactivity to the intervention could mediate smoking outcomes. Therefore, the present research proposes to assess facial morphing intervention effectiveness in relation to individual's physiological shock reactions to viewing the morphed images and moderator variables in a large sample of women across a broad age range.
Objectives:
Primary Objectives- To assess effectiveness of an appearance-based intervention on smoking outcomes in a female population (18-55 years old) immediately after the intervention session and at 1, 3 and 6 months post intervention session. In addition to compare the results to that of a standard stop smoking intervention.
An additional primary objective will be to compare the primary outcome measures for both appearance-based intervention instruction conditions (neutral vs additional) immediately after the intervention and at 1, 3 and 6 months after to assess which instruction type is more effective in reducing smoking behaviour.
Other objectives-
- Investigate the mediating effects of physiological arousal [measured during the intervention by electro dermal activity and beats per a minute (BPM, derived from pulse rate)] on the intervention efficacy as measured by the primary and secondary outcome measures.
- Investigate the impact of moderating variables on the primary outcome measures.
Measures
Outcome measures -
- The primary outcomes will be smoking intentions measured pre, immediately after and at 1, 3 and 6 months post intervention.
- Secondary outcome measures will be smoking cognitions (attitudes, subjective norms and perceived behavioural control), nicotine dependence and self-reported smoking behaviour measured pre, immediately after and at 1, 3 and 6 month post the intervention.
Participants:
Current female smokers aged 18-55 will be recruited and randomised into one of three conditions. (1) Appearance-based intervention neutral, (2) Appearance-based intervention additional instructions, (3) Control general stop smoking intervention. Participants are eligible to take part if they are a female between the ages of 18-55 and that they smoke at least one cigarette a week. Participants are informed to withhold from taking part if they have any mental health issues that may be affected by appearance-based imagery.
Randomisation will be achieved through using SPSS (V25) to create two sets of randomisation one for participants over the age of 35 and another for women under the age 35 to allow an equal distribution of ages into each condition.
Protocol:
At the start of the intervention session participants will be asked to provide informed consent, immediately after electrodes and a light sensor will be placed on the participants non-dominant hand. Participants are then asked to fill in a self-report questionnaire including demographic questions and stress confounders, smoking behaviour, cognitions and quit attempts, levels of anxiety and depression, how much they consider their future consequences and how they view their appearance.
Participants in the two appearance-based interventions groups will then have a photo taken of their face and aged with the effects of smoking in a range of morphing sequences and then given a general stop smoking booklet alternatively participants allocated to the control condition will be asked to only read a general stop smoking intervention booklet. All three conditions will then be asked to provide carbon monoxide breath reading using a hand held battery operated device. The participants smoking cognitions and behaviours will then be measured again immediately and longer term at 1, 3 and 6 months post intervention.
Sample size calculation:
In a previous randomized controlled trial (RCT) on an appearance-based intervention for female smokers , 35 women were allocated to one of two conditions (control group or intervention) with a reported effect size of d=.63 for nicotine dependence at 4 weeks post-intervention. Based on previous research and to account for a 30% dropout at six-month follow up 50 participants per group is required in the current study. Additionally, an a priori power analysis has been conducted using GPower which supports the specified number of participants per group. Specifically, to obtain a medium effect of .25 and a power of .80 at alpha .05, a total sample of 158 is required (52 per group).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention Neutral instructions | Experimental | Other: AprilAge- facial morphing appearance based intervention for smokingAppearance based intervention group delivered with neutral instructions from the investigator alongside general stop smoking intervention leaflet. |
| Intervention Additional instructions | Experimental | Other: AprilAge- facial morphing appearance based intervention for smokingAppearance based intervention group delivered with neutral instructions with additional reassuring messages from the investigator alongside general stop smoking intervention leaflet. |
| Control | No intervention | –Neutral task plus the general stop smoking intervention in the form of a leaflet, administered by the investigator. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female
- Aged 18-55
- Smoke at least 1 cigarette a week
Key exclusion criteria (2 listed)
- Non-smokers
- Self-reported appearance related mental health issue
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 |
|---|---|---|
| AprilAge- facial morphing appearance based intervention for smokingAlso: Appearance-based intervention, Appearance orientated intervention, Internet-based Photo aging interventionAppearance-based intervention: The intervention is a software that ages an individual's face with and without the effects of smoking. Participants have their photo taken on a laptop webcam, they are then asked to report their age and ethnicity in order to calibrate the software, the participants picture is then matched to a stock image. The participants will see two images on the screen, on the left is there face aged without the effects of smoking and one the right aged with the effects of smoking. Participants will be led through a series of morphing sequences (1-5). In-between each of the morphing sequences (Morph1 to Morph5) the participant will be asked to comment on the differences they can see between the two images. General stop smoking intervention: The General stop smoking intervention comes in the form of a NHS stop smoking information leaflet. The participants will be given the leaflet on a laptop screen and asked to read through the whole document. | Other | Intervention Additional instructions, Intervention Neutral instructions |
Primary outcome
Change in Smoking Intentions
Time frame: Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
Smoking Intentions, which are intentions the participant has to quit smoking are measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Three items are each asked on a 13-point scale producing a combined score between 0-39. The score from each individual item is then averaged together to create a total score for smoking intentions. The higher the averaged score the more intention the participant has to quit smoking.The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011).
5 secondary outcomes
Change in Smoking Attitudes
Time frame: Measures obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
Change in Smoking Subjective Norms
Time frame: Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
Change in Smoking Perceived Behavioural Control
Time frame: Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
Change in Nicotine dependence
Time frame: Measure obtained pre-intervention and again at 1, 3 and 6 months post-intervention.
Change in Self-reported smoking behaviour
Time frame: Measure obtained pre-intervention and again at 1, 3 and 6 months post-intervention.
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 4 Sep 2020.
- Background: PubMed 11832252Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
- Background: PubMed 9768298Borrelli B, Mermelstein R. The role of weight concern and self-efficacy in smoking cessation and weight gain among smokers in a clinic-based cessation program. Addict Behav. 1998 Sep-Oct;23(5):609-22. doi: 10.1016/s0306-4603(98)00014-8.
- BackgroundCash, T. F. (2016) 'Multidimensional Body-Self Relations Questionnaire (MBSRQ).' In Wade, T. (ed.) Encyclopedia of Feeding and Eating Disorders. Singapore: Springer Singapore, pp. 1-4.
- Background: PubMed 2030191DiClemente CC, Prochaska JO, Fairhurst SK, Velicer WF, Velasquez MM, Rossi JS. The process of smoking cessation: an analysis of precontemplation, contemplation, and preparation stages of change. J Consult Clin Psychol. 1991 Apr;59(2):295-304. doi: 10.1037//0022-006x.59.2.295.
- Background: PubMed 22573734Flett K, Clark-Carter D, Grogan S, Davey R. How effective are physical appearance interventions in changing smoking perceptions, attitudes and behaviours? A systematic review. Tob Control. 2013 Mar;22(2):74-9. doi: 10.1136/tobaccocontrol-2011-050236. Epub 2012 May 9.
- Background: PubMed 26338489Flett K, Grogan S, Clark-Carter D, Gough B, Conner M. Male smokers' experiences of an appearance-focused facial-ageing intervention. J Health Psychol. 2017 Mar;22(4):422-433. doi: 10.1177/1359105315603477. Epub 2016 Jul 10.
- Background: PubMed 21199543Grogan S, Flett K, Clark-Carter D, Gough B, Davey R, Richardson D, Rajaratnam G. Women smokers' experiences of an age-appearance anti-smoking intervention: a qualitative study. Br J Health Psychol. 2011 Nov;16(4):675-89. doi: 10.1348/2044-8287.002006. Epub 2010 Dec 6.
- Background: PubMed 21767016Grogan S, Flett K, Clark-Carter D, Conner M, Davey R, Richardson D, Rajaratnam G. A randomized controlled trial of an appearance-related smoking intervention. Health Psychol. 2011 Nov;30(6):805-9. doi: 10.1037/a0024745. Epub 2011 Jul 18.
- Background: PubMed 21897887Gupta SK. Intention-to-treat concept: A review. Perspect Clin Res. 2011 Jul;2(3):109-12. doi: 10.4103/2229-3485.83221.
- Background: PubMed 11895509Koh JS, Kang H, Choi SW, Kim HO. Cigarette smoking associated with premature facial wrinkling: image analysis of facial skin replicas. Int J Dermatol. 2002 Jan;41(1):21-7. doi: 10.1046/j.1365-4362.2002.01352.x.
- BackgroundStrathman, A., Gleicher, F., Boninger, D. S. and Edwards, C. S. (1994) 'The consideration of future consequences: Weighing immediate and distant outcomes of behavior.' Journal of Personality and Social Psychology, 66(4) pp. 742-752.
- Derived from this study: PubMed 38724879Walker L, Grogan S, Denovan A, Scholtens K, McMillan B, Conner M, Epton T, Armitage CJ, Cordero MI. An Age-Progression Intervention for Smoking Cessation: A Pilot Study Investigating the Influence of Two Sets of Instructions on Intervention Efficacy. Int J Behav Med. 2026 Feb;33(1):128-137. doi: 10.1007/s12529-024-10285-3. Epub 2024 May 9.
- Individual participant dataSharing planned: No
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Smoking Cessation
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AprilAge- facial morphing appearance based intervention for smoking in people with Smoking Cessation, run by Manchester Metropolitan University 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 2 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 4 Sep 2020. 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. 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?
Change in Smoking Intentions (time frame: Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.). 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 NCT03749382, which also lists 12 linked publications.
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 4 Sep 2020.