Clinical trial NCT03749382: Testing Smoking Interventions in Women
Official title: A Randomized Controlled Trial of Smoking Interventions in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking
Tobacco
Cessation
Intervention
Lead sponsor: Manchester Metropolitan University
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: OTHER

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.

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-

1. 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.
2. Investigate the impact of moderating variables on the primary outcome measures.

Measures

Outcome measures -

1. The primary outcomes will be smoking intentions measured pre, immediately after and at 1, 3 and 6 months post intervention.
2. 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Smoking Intentions
timeFrame: Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
Secondary outcomes:
measure: Change in Smoking Attitudes
timeFrame: Measures obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
measure: Change in Smoking Subjective Norms
timeFrame: Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
measure: Change in Smoking Perceived Behavioural Control
timeFrame: Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
measure: Change in Nicotine dependence
timeFrame: Measure obtained pre-intervention and again at 1, 3 and 6 months post-intervention.
measure: Change in Self-reported smoking behaviour
timeFrame: Measure obtained pre-intervention and again at 1, 3 and 6 months post-intervention.
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Brooks Building
Study officials:
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