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
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.
Citation
@article{adrian2020,
author = {Taylor, Adrian and Thompson, Tom P. and Ussher, Michael and
Aveyard, Paul and Murray, Rachael L. and Harris, Tess and Creanor,
Siobhan and Green, Colin and Streeter, Adam Justin and Chynoweth,
Jade and Ingram, Wendy and Greaves, Colin J. and Hancocks, Helen and
Snowsill, Tristan and Callaghan, Lynne and Price, Lisa and Horrell,
Jane and King, Jennie and Gude, Alex and George, Mary and Wahlich,
Charlotte and Hamilton, Louisa and Cheema, Kelisha and Campbell,
Sarah and Preece, Dan},
title = {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}},
journal = {BMJ Open},
volume = {10},
number = {12},
pages = {e043331},
date = {2020-12-01},
url = {https://tristansnowsill.co.uk/randomised-controlled-trial-of-tailored-support.html},
doi = {10.1136/bmjopen-2020-043331},
langid = {en},
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.}
}