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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: 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.

SUBMITTER: Taylor A

PROVIDER: S-EPMC7709511 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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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.

Taylor Adrian A Thompson Tom P TP Ussher Michael M Aveyard Paul P Murray Rachael L RL Harris Tess T Creanor Siobhan S Green Colin C Streeter Adam Justin AJ Chynoweth Jade J Ingram Wendy W Greaves Colin J CJ Hancocks Helen H Snowsill Tristan T Callaghan Lynne L Price Lisa L Horrell Jane J King Jennie J Gude Alex A George Mary M Wahlich Charlotte C Hamilton Louisa L Cheema Kelisha K Campbell Sarah S Preece Dan D

BMJ open 20201201 12

<h4>Introduction</h4>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.<h4>Methods and analysis</h4>A pragmatic, multicentred, parallel, two group, randomised c ...[more]

PMID: 33262194

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Project description:IntroductionThis study used data from a randomized controlled trial evaluating the efficacy of motivational interviewing (MI) relative to health education (HE) and brief advice (BA) to encourage quit attempts and cessation in order to determine their relative cost-effectiveness.Aims and methodsUrban community residents (n = 255) with low desire to quit smoking were randomized to MI, HE, or BA which differed in communication style and/or number of treatment sessions. Incremental cost-effectiveness ratios were used to compare the intensive interventions (MI and HE) to BA for facilitating quit attempts and smoking cessation. Costs were calculated from the perspective of an agency that might engage in program delivery. Sensitivity analysis examined different assumptions for MI training and pharmacotherapy costs.ResultsTotal intervention delivery time costs per participant for MI, HE, and BA were $46.63, $42.87, and $2.4, respectively. Cost-effectiveness ratios per quit attempt at 24 weeks were $380 for MI, $272 for HE, and $209 for BA. The cost per additional quit attempt for MI and HE relative to BA was $508 and $301, respectively. The cost per additional quit for MI and HE relative to BA was $2030 and $752, respectively. Four separate sensitivity analyses conducted in our study did not change the conclusion the HE had a lower Incremental Cost-Effectiveness Ratio for both quit attempts and cessation.ConclusionsHE was the most cost-effective of the three types of smoking cessation induction therapies and therefore may be preferable for smokers who are less motivated to quit. Providing valuable cost information in choosing different clinical methods for motivating smokers to quit.ImplicationsAll direct costs and activity-based time costs associated with delivering the intervention were analyzed from the perspective of an agency that may wish to replicate these strategies. A randomized controlled trial evaluating the efficacy of MI relative to HE and BA to encourage quit attempts and cessation determined their relative cost-effectiveness. HE was the most cost-effective of the three types of smoking cessation induction therapies and therefore may be preferable. Despite guideline recommendations, MI may not be the best approach to encourage quit attempts in diverse populations. Rather, a structured, intensive HE intervention might be the most cost-effective alternative.

Project description:BackgroundSetting a target quit date (TQD) is often an important component in smoking cessation treatment, but ambiguity remains concerning the optimal timing (ie, quitting spontaneously versus delaying to prepare).ObjectiveWe examined four questions about the timing of TQDs and smoking outcomes in secondary analyses of The iQUITT Study, a randomized trial of Internet and telephone treatment for cessation: (1) What are the characteristics of TQDs set using an online interactive quit date tool?, (2) What are the characteristics of individuals who use a quit date tool and do they differ from those who do not?, (3) Are there differences in smoker characteristics, treatment utilization, and cessation outcomes based TQD timing?, and (4) Is maintenance of an initial TQD predictive of abstinence or do changes to TQDs lead to cessation?MethodsA total of 825 adult current cigarette smokers were randomized to enhanced Internet or enhanced Internet plus telephone counseling. Latency to TQD in days was calculated as the date difference between the initial TQD and enhanced Internet registration; prospective TQD setters were stratified into four latency groups (0, 1-14, 15-28, 29+ days). Baseline variables, website utilization, and 3-month cessation outcomes were examined between prospective TQD groups. Desire and confidence to quit, number of TQDs, and website logins were tested as predictors of 30-day point prevalence abstinence (ppa) at 3 months (responder-only analyses). Classification and regression tree (CART) analysis explored interactions among baseline variables, website utilization, and latency to TQD as predictors of 30-day ppa.ResultsThere were few baseline differences between individuals who used the quit date tool and those who did not. Prospective TQDs were set as follows: registration day was 17.1% (73/427), 1-14 days was 37.7% (161/427), 15-28 days was 18.5% (79/427), and 29+ days was 26.7% (114/427). Participants with a TQD within 2 weeks had higher baseline self-efficacy scores but did not differ on smoking variables. Individuals whose TQD was the same day as registration had the highest logins, page views, number of TQDs set using the tool, and messages sent to other members. Logistic regression revealed a significant interaction between number of TQDs and website logins for 30-day ppa (P=.005). Among those with high logins, 41.8% (33/79) with 1 TQD were abstinent versus 25.9% (35/135) with 2+TQDs. Logins and self-efficacy predicted 30-day ppa in the CART model.ConclusionsTQD timing did not predict cessation outcomes in standard or exploratory analyses. Self-efficacy and an apparent commitment to an initial TQD were the components most highly related to abstinence but only via interactions with website utilization. Findings highlight the importance of feeling efficacious about handling specific smoking situations and engaging with treatment. Additional research focused on increasing engagement in Web-based cessation studies is needed.Trial registrationClinicalTrials.gov: NCT00282009; http://clinicaltrials.gov/show/NCT00282009 (Archived by WebCite at http://www.webcitation.org/6Kt7NrXDl).

Project description:AimsTo test whether, in comparison to usual care, brief motivational or reduction interventions increase quit attempts (QA) or abstinence among smokers who are not ready to quit.DesignA parallel-group randomized controlled trial of brief motivational (n = 185), reduction (n = 186) or usual care (n = 189) telephone interventions delivered over the course of 4 weeks. Outcomes were assessed at 6- and 12-month follow-ups. No medication was provided.SettingUnited States.ParticipantsA total of 560 adult smokers of ≥ 10 cigarettes per day who were not ready to quit in the next 30 days.MeasurementsThe primary outcomes were whether participants made a QA that lasted ≥ 24 hours and whether they made a QA of any length between baseline and 6 months. Secondary outcomes included 7-day point-prevalence abstinence at 6 and 12 months. The 12-month follow-up was added after the study began.FindingsA priori-defined comparisons were between motivational versus usual care and reduction versus usual care conditions. The probability of making a QA that lasted ≥ 24 hours was not significantly different between the motivational (38%) or the reduction (31%) conditions and the usual care (34%) condition [motivational versus usual care odds ratio (OR) = 1.19, 95% confidence interval (CI) = 0.78-1.82; reduction versus usual care OR = 0.89, 95% CI = 0.57-1.36]. Bayes factors ranged from 0.13 to 0.18. Findings regarding a QA of any length were similar. At 6 months, the motivational condition had marginally more abstinence than usual care (11 versus 5%, OR = 2.17, 95% CI = 0.99-4.77), but the reduction condition was not significantly different from usual care (8 versus 5%, OR = 1.57, 95% CI = 0.69-3.59). At 12 months, the motivational condition had significantly more abstinence than usual care (10 versus 4%, OR = 2.80, 95% CI = 1.14-6.88) and the reduction condition had marginally more abstinence than usual care (9 versus 4%, OR = 2.45, 95% CI = 0.98-6.09).ConclusionsAmong adult smokers who are not ready to quit, both logistic regression and Bayesian analysis indicate that neither motivational nor reduction-based telephone interventions increased the odds of making a quit attempt in comparison to usual care at 6 months. The motivational intervention appeared to increase abstinence at 6 months and did increase abstinence at 12 months. The reduction intervention did not increase abstinence at 6 months but appeared to increase abstinence at 12 months.

Dataset Information

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.

Publications

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.

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