Excercise Assisted Reduction then Stop (EARS) 

An exploratory trial to evaluate the effects of a physical activity intervention as a smoking cessation induction and cessation aid among the 'hard to reach'.

Aims

• To develop a multi-component Physical Activity intervention aimed at helping smokers (not intending to quit in the next month), among 'hard to reach' groups, to cut down

The study has also a number of secondary objectives:

• To assess via interview the acceptability of such a PA intervention as an aid to cutting down, among 'hard to reach' smokers
• To assess via interview the acceptability of recruitment, assessment and randomisation procedures within a pilot pragmatic randomised controlled trial to compare the effects of a PA intervention versus brief advice (usual care) on quitting, among 'hard to reach' smokers
• To obtain an estimate of the intervention (PA vs brief advice) effect size, relative risk and its precision to inform sample size calculations for a fully powered trial, from a pilot randomised trial to assess cabon monoxide confirmed abstinence at 4 weeks post-quit date
• To assess process measures at 4, 8 and 16 weeks post-baseline including: self-reported cigarettes smoked; number of quit attempts; self-reported quality of life; mood and physical symptoms; cravings; PA by self-report and accelerometer (in a sub-sample); pharmacological and behavioural support used; and weight
• To estimate the resource used and costs associated with delivery of the intervention, and to pilot methods for determinging future cost-effectiveness analyses

Study design

A preliminary phase to the study will explore the utility of using various approaches to recruit ‘hard to reach’ smokers, including via GPs and advertisements placed in the community.

This will inform the recruitment methods to be used in an exploratory randomised controlled trial involving 120 heavy smokers (>15 cigarettes per day) from ‘hard to reach’ groups who wish to cut down the number of cigarettes they smoke but do not wish to quit within the next month.

Smokers will be randomised equally to one of two groups:

1.Brief advice

Advice on cutting down will be given: written and verbal information on the NHS Stop Smoking Service (SSS) with information on the benefits of quitting and how to quit, will be provided at baseline. Those expressing a desire to make a quit attempt will subsequently be referred to the relevant NHS SSS.

2.Brief advice plus Physical Activity intervention

Written and verbal information on NHS SSS (Stop Smoking Service), with information on the benefits of quitting and how to quit provided at baseline. Smokers will select one of three strategies for smoking reduction and receive weekly support to attain this. Face to face physical activity support sessions will be conducted at weeks 1, 4, and 8 along with supportive phone calls in each intermediate week.

The communications will involve tailored physical activity counselling guidance on using a free pedometer to achieve SMART goals, signposting to local exercise opportunities with subsidised access as required, with the aim of increasing the amount of regular physical activity completed by each participant for both implicit and explicit purposes as an aid to quit. Those expressing a desire to make a quit attempt will subsequently be referred to NHS SSS

Data collection

Date will be collected at the following time points:

• Screening/Baseline Assessment: demorgraphics, height and weight, expired carbon monoxide (CO) measurement, randomisation, questionnaires, accelerometer (1 week, sub sample)
• At 4 weeks: questionnaires will be administered to participants
• At 8 weeks (or start of quit attempt): questionnaires, height and weight, expired CO measurement, accelerometer (1 week, sub sample)
• At 16 weeks (or 4 weeks post quit) follow up assessment: questionnaires, height and weight, expired CO measurement, accelerometer (1 week, sub sample)