Title: A multi-centred Trial of physical Activity assisted Reduction of Smoking (TARS)
Funder: Department of Health and Social Care

Abstract: Study design: A 4 site, parallel, two group RCT, with internal pilot, to compare (i) tailored support to reduce smoking and increase physical activity as an aid to smoking reduction (and possible cessation) with (ii) brief advice to reduce or quit smoking. Setting: Recruitment in primary care including searching electronic health records and mailed invitation. Reviewing literature: A pilot RCT tested the feasibility and acceptability of trial methods and the intervention, and found preliminary evidence for effectiveness. We updated a systematic review on exercise and smoking cessation; no other studies relevant to this bid were identified. The findings from a larger trial could contribute to updates of NICE guidelines for smoking harm reduction. Target group: Adult smokers wishing to reduce smoking but with no immediate plans to quit. Inclusion/Exclusion Criteria: Smokers registered with a GP, aged 18 yrs or over, smoking 10 or more cigarettes per day, able to engage in moderate intensity physical activity. Health technologies being assessed: Access to pharmacological and behavioural support to gradually reduce smoking, and increase physical activity as a reduction aid, delivered in up to 8 client-centred individual motivational support sessions, via phone or in person, for up to 8 weeks. Smokers will also be directed to Stop Smoking Services for support if they wish to quit. Measurement of costs and outcomes: Primary outcome: Carbon monoxide (CO) verified prolonged abstinence at 8 months post baseline. Secondary outcomes: CO verified abstinence at 3 and 15 months post baseline (only contacting those abstinent at 8 months). Surveys mailed at 3 and 8 months to assess cigarettes smoked (and reduction), health related quality of life, physical activity, mental health, cravings, weight, smoking related costs, health service utilisation and costs. Physical activity (accelerometer) assessed at 3 mths in random sample. Those self-reporting abstinence at 3, 8 and 15 mths will have face to face assessment of CO expired air. Embedded mixed methods process evaluation to assess intervention fidelity, behaviour change processes and moderators and mediators of any effects. Sample size: Various assumptions are made about the expected control and intervention abstinence rates, drawing on relevant literature. A sample size of 450 per group would give 90% power to detect an increase in CO confirmed abstinence rate from 5% to 11% (alpha=0.05, 2-sided test) at 8 months post baseline. The main analyses of abstinence rates will be conducted on an intention-to-treat basis, with participants lost to follow up regarded as still smoking. Difference between current and planned care pathways: Usual care will be guided by NICE. Health trainers typically advise smokers to stop or refer smokers to NHS Stop Smoking Services: In the proposed intervention they will support smoking reduction integrated with physical activity promotion. Project timetable: Set up phase (month 1-8), recruitment (month 9-20), final 15 month data collection (mth 35), data cleaning and analysis (month 36-43); final report (month 44). In mth 12 we will assess progression rules (for recruitment and intervention engagement) from internal pilot to full trial. If data analysis (months 29-30) shows no intervention effect then the trial will be stopped with no follow-up at 15 mths, and final report submitted in month 39. We aim to recruit 20 participants per month at each of 4 sites.

Lay abstract: Background: The NHS provides Stop Smoking Services to help smokers quit smoking because using help like nicotine patches and behavioural support is very effective. A recent small pilot study showed some evidence that providing personal support to reduce cigarettes and to increase physical activity may reduce smoking, and induce more quit attempts and short-term abstinence. By also focusing on increasing healthy behaviours some smokers may to want to reduce and ultimately quit. There are recent national guidelines to help smokers who are not ready to quit but until a larger study provides evidence that reducing smoking and increasing physical activity is effective such an approach will not feature in any future updated guidelines. Aims: The overall aim of the proposed research is to examine if supporting smokers (who do not want to quit immediately) to reduce smoking and increase physical activity results in a reduction in smoking and, most importantly, in more smokers deciding to quit, and remain abstinent for at least 12 months, compared to those receiving usual support. The research will also determine if the intervention improves measures of well-being, weight and physical activity. The effects of the intervention and estimated cost will also be used to determine if the novel intervention is cost-effective, and would have long-term savings for the NHS. Design & methods: To achieve the aims we will conduct a study in which suitable smokers recruited from primary health care will be assigned at random to receive either usual advice on reducing smoking and where to get further support, or up to 8 face to face or phone contacts with a health trainer for up to 8 weeks with support to reduce smoking and increase physical activity as decided by the smoker. After completing an initial assessment, all participants will be asked to complete various surveys and measures after 3, and 8 months. Only if participants report that they are no longer smoking at 3 and 8 months will they be asked to attend a face to face meeting with a researcher, to confirm abstinence using expired air levels of carbon monoxide. Only if after 8 months they are abstinent will they be followed up after 15 months. The number of participants needed for the study will be 900, coming from 4 sites (Plymouth, Oxford, Nottingham and London). This will allow us to say with certainty whether the health trainer support is effective or not. We will also estimate the intervention costs and predict what long-term health and social care savings this may produce. Patient and public involvement: The research team have had extensive engagement with smokers about how they reduce their smoking or quit, and use physical activity to manage urges to smoke, weight gain from smoking cessation, and as a diversionary activity, for the past 15 years. The proposed study will involve further public & patient input into the study methods and management, what the health trainer support will involve, and interpretation and dissemination of the findings. Dissemination: We shall publish our results in medical and health journals as well as the popular press and present at conferences. We will work with various stakeholders at local, regional and national level to ensure the findings are fully disseminated, and influence policy and practice, such as NICE Guidelines for tobacco harm reduction as appropriate.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;RESPIRATORY;STROKE