Randomised controlled trial of tailored support to increase physical activity and reduce smoking in smokers not immediately ready to quit: protocol for the Trial of physical Activity-assisted Reduction of Smoking (TARS) Study

Abstract

IntroductionSmoking reduction can lead to increased success in quitting. This study aims to determine if a client-focused motivational support package for smoking reduction (and quitting) and increasing (or otherwise using) physical activity (PA) can help smokers who do not wish to quit immediately to reduce the amount they smoke, and ultimately quit. This paper reports the study design and methods.Methods and analysisA pragmatic, multicentred, parallel, two group, randomised controlled superiority clinical trial, with embedded process evaluation and economics evaluation. Participants who wished to reduce smoking with no immediate plans to quit were randomised 1:1 to receive either (1) tailored individual health trainer face-to-face and/or telephone support to reduce smoking and increase PA as an aid to smoking reduction (intervention) or (2) brief written/electronic advice to reduce or quit smoking (control). Participants in both arms of the trial were also signposted to usual local support for smoking reduction and quitting. The primary outcome measure is 6-month carbon monoxide-confirmed floating prolonged abstinence following participant self-reported quitting on a mailed questionnaire at 3 and 9 months post-baseline. Participants confirmed as abstinent at 9 months will be followed up at 15 months.Ethics and disseminationApproved by SW Bristol National Health Service Research Committee (17/SW/0223). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will be disseminated to trial participants and healthcare providers.Trial registration numberNCT47776579.

Effectiveness and cost‐effectiveness of behavioural support for prolonged abstinence for smokers wishing to reduce but not quit: Randomised controlled trial of physical activity assisted reduction of smoking (TARS)

“…Briefly, intervention participants were offered up to eight, usually weekly, behavioural support sessions, face-to-face or by phone, lasting 10 to 60 minutes, to reduce smoking and increase physical activity, as described in detail elsewhere [20]. Up to six additional cessation-support sessions were offered to participants who decided to make a quit attempt.…”

“…We conducted a pragmatic, multi-centred, parallel two-arm, community-based, randomised controlled, superiority trial. The published protocol describes the trial procedures in detail [20].…”

Motivational support intervention to reduce smoking and increase physical activity in smokers not ready to quit: the TARS RCT

“…The intervention components and content and the delivery details have been described elsewhere. 32 Adaptations from the EARS pilot trial intervention included the following: (1) accommodating participants who were using or wanted to use vaping to manage smoking and align with guidance and practice in usual care; (2) improving the focus in the training and supervision of HTs on encouraging participants to manage social influence to increase PA and reduce smoking, which appeared to be the least evident HT competency; 33 and (3) improving the focus in the training and supervision of HTs on promoting PA as well as smoking reduction (and quitting), which was also identified in an analysis of HT competencies.…”

“…Adult smokers wanting to reduce the amount they smoke, but with no immediate plans to quit smoking, were recruited from general practices, secondary care and community settings around four collaborating university sites in the UK: Nottingham, Oxford, Plymouth, and St George's, University of London (South London). 32 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.…”

“…The intervention is described in detail elsewhere. 32 Briefly, participants in the intervention arm were offered individually tailored behavioural support from a HT in up to eight weekly sessions, the goal being to build a participant's motivation and confidence to reduce smoking and increase PA, and possibly to make a quit attempt. An additional six weekly sessions were offered to those participants who wanted support after quitting smoking.…”