Smokers who want to cut down but aren’t ready to quit will get support to reduce smoking while increasing physical activity, tested against standard brief advice in a randomised trial across four UK sites. This matters because current NHS stop-smoking services focus on abrupt quitting, leaving a gap for the many smokers who want to reduce first. The trial updates a systematic review on exercise and smoking cessation and could feed directly into NICE guidelines for harm reduction. If the intervention works, it would give GPs and health trainers a practical, evidence-based tool to help a large group of smokers who currently fall through the cracks. The approach combines pharmacological and behavioural support with physical activity—up to eight motivational sessions by phone or in person—and directs those ready to quit to Stop Smoking Services. Success would mean a new, scalable pathway for reducing smoking-related illness without requiring immediate cessation, potentially shifting public health strategy toward harm reduction alongside abstinence.
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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.
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