Testing Smoking Interventions in Women

NCT03749382 | Completed

• 1 other identifier: 0245
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Smoking Cessation

Keywords

Smoking; Tobacco; Cessation; Intervention

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  Measures obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.

• Change in Smoking Subjective Norms

  Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.

• Change in Smoking Perceived Behavioural Control

  Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.

• Change in Nicotine dependence

  Measure obtained pre-intervention and again at 1, 3 and 6 months post-intervention.

• Change in Self-reported smoking behaviour

  Measure obtained pre-intervention and again at 1, 3 and 6 months post-intervention.

Study Arms (3)

Intervention Neutral instructions

EXPERIMENTAL

Appearance based intervention group delivered with neutral instructions from the investigator alongside general stop smoking intervention leaflet.

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.

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.

Interventions

AprilAge- facial morphing appearance based intervention for smoking OTHER

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.

Also known as: Appearance-based intervention, Appearance orientated intervention, Internet-based Photo aging intervention

Intervention Additional instructions; Intervention Neutral instructions

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Aged 18-55
• Smoke at least 1 cigarette a week

You may not qualify if:

• Non-smokers
• Self-reported appearance related mental health issue

Sponsors & Collaborators

• Manchester Metropolitan University: lead

Study Sites (1)

Brooks Building

Manchester, M156GX, United Kingdom

Location

Related Publications (12)

• 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.

  PMID: 11832252 BACKGROUND

• Borrelli 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.

  PMID: 9768298 BACKGROUND

• Cash, 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

• 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.

  PMID: 2030191 BACKGROUND

• Flett 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.

  PMID: 22573734 BACKGROUND

• Flett 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.

  PMID: 26338489 BACKGROUND

• Grogan 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.

  PMID: 21199543 BACKGROUND

• Grogan 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.

  PMID: 21767016 BACKGROUND

• Gupta SK. Intention-to-treat concept: A review. Perspect Clin Res. 2011 Jul;2(3):109-12. doi: 10.4103/2229-3485.83221.

  PMID: 21897887 BACKGROUND

• Koh 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.

  PMID: 11895509 BACKGROUND

• Strathman, 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.

  BACKGROUND

• 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. 2024 May 9. doi: 10.1007/s12529-024-10285-3. Online ahead of print.

  PMID: 38724879 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Smoking

Interventions

Smoking Devices

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will receive a brief description of both the appearance-based intervention and general stop smoking intervention. Participants will not know prior to taking part which condition they will be randomised into, on completion of the intervention it will become apparent whether they received the appearance-based intervention or general intervention. For participants randomised to the appearance intervention the instruction type will remain concealed. The investigator will not be blind throughout.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinical Investigator

Model Details: Parallel assignment

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 21, 2018
• Study Start: January 10, 2019
• Primary Completion: August 20, 2020
• Study Completion: August 20, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)