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. 2020 Dec 1;10(12):e043331.
doi: 10.1136/bmjopen-2020-043331.

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

Adrian Taylor  1 , Tom P Thompson  2 , Michael Ussher  3   4 , Paul Aveyard  5 , Rachael L Murray  6 , Tess Harris  3 , Siobhan Creanor  2 , Colin Green  7 , Adam Justin Streeter  2 , Jade Chynoweth  2 , Wendy Ingram  2 , Colin J Greaves  8 , Helen Hancocks  2 , Tristan Snowsill  7 , Lynne Callaghan  2 , Lisa Price  9 , Jane Horrell  2 , Jennie King  2 , Alex Gude  2 , Mary George  3 , Charlotte Wahlich  3 , Louisa Hamilton  5 , Kelisha Cheema  6 , Sarah Campbell  2 , Dan Preece  10
Affiliations

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

Adrian Taylor et al. BMJ Open. .

Abstract

Introduction: Smoking 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 analysis: A 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 dissemination: Approved 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 number: ISRCTN47776579; Pre-results.

Keywords: clinical trials; primary care; public health.

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Conflict of interest statement

Competing interests: AG, AJS, AT, CJG, CG, CW, DP, HH, JC, JK, LC, LH, MG, MU, PA, RLM, SCr, SCa, TH, TS, TPT and WI report a grant from NIHR (NIHR HTA award ref 15/111/01) during the conduct of the study. PA is an NIHR Senior Investigator and is part funded by NIHR Oxford Biomedical Research Centre and Applied Research Centre. SCr reports grants from NIHR HTA during the conduct of the study, and various other grants from NIHR and UK charities outside the submitted work. She is also Interim Codirector (and previously Director) of the UKCRC-registered Peninsula Clinical Trials Unit, which is in receipt of NIHR Clinical Trials Unit Support Funding (current award ends 31 August 2021). LP reports consultancy fees from NIHR during the conduct of the study; grants from Living Streets Charity, personal fees from NIHR, personal fees from NIHR PHR, personal fees from NIHR PHR rapid response, grants from Wellcome Trust seed corn (internal funding) outside the submitted work; and discloses that the physical activity group in Sport and Health Sciences at the University of Exeter has a collaboration with Activinsights (the manufacturer of the physical activity monitor), to provide study design advice and data analysis, but that analysis of the physical activity data in the present study was not undertaken as part of that service.

Figures

Figure 1
Figure 1
Participant flow chart. GP, general practitioner; NHS, National Health Service; NICE, National Institute for Health and Care Excellence.
Figure 2
Figure 2
Indicative map of the TARS intervention components. TARS, Trial of physical Activity-assisted Reduction of Smoking.
See this image and copyright information in PMC

References

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