Dataset Information

Smoking cessation using preference-based tools among socially disadvantaged smokers: study protocol for a pragmatic, multicentre randomised controlled trial.

ABSTRACT:

Introduction

Many smoking cessation aids such as nicotine replacement treatments and e-cigarettes have been proven effective in aiding smoking cessation attempts. Encouraging smokers with low socioeconomic position (SEP) to choose their smoking aid tool based on their preferences, and giving that tool free of charge, might increase the odds of smoking cessation. This trial examines the effectiveness of the 'STOP' (Sevrage Tabagique à l'aide d'Outils dédiés selon la Préférence: Smoking cessation using preference-based tools), a preference-based smoking cessation intervention for smokers with low SEP.

Methods and analysis

The STOP study is a randomised, multicentre, controlled trial (RCT). Smokers with low SEP and wishing to quit will be randomised to either the intervention or the control group (standard care). Participants in the intervention group will be asked to choose between different types of nicotine substitutes (patches, inhalers, gum, tablets, etc) and/or an electronic cigarette which will be delivered free of charge to aid their smoking cessation attempt.The primary outcome will be smoking abstinence at 6 months after inclusion, defined as self-reported 7-day point prevalence of tobacco abstinence. Secondary outcomes include the total number of days of abstinence at 6 months after inclusion, 7-day point prevalence tobacco abstinence at 1 and 3 months after inclusion and number of relapses.The study will also include an economic evaluation, and a process evaluation using a mixed methods approach.

Ethics and dissemination

The study was approved by the 'Île de France II' Institutional Review Board on 8 September 2020 (CPP Île de France II; Ref No: 20.01.31.65528 RIPH2 HPS), and results will be published in a peer-reviewed journal.

Trial registration number

NCT04654585.

SUBMITTER: El-Khoury F

PROVIDER: S-EPMC8246378 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveTo evaluate the efficacy of financial incentives dependent on continuous smoking abstinence on smoking cessation and birth outcomes among pregnant smokers.DesignSingle blind, randomised controlled trial.SettingFinancial Incentive for Smoking Cessation in Pregnancy (FISCP) trial in 18 maternity wards in France.Participants460 pregnant smokers aged at least 18 years who smoked ≤5 cigarettes/day or ≤3 roll-your-own cigarettes/day and had a pregnancy gestation of <18 weeks were randomised to a financial incentives group (n=231) or a control group (n=229).InterventionsParticipants in the financial incentives group received a voucher equivalent to €20 (£17; $23), and further progressively increasing vouchers at each study visit if they remained abstinent. Participants in the control group received no financial incentive for abstinence. All participants received a €20 show-up fee at each of six visits.Main outcome measuresThe main outcome measure was continuous smoking abstinence from the first post-quit date visit to visit 6, before delivery. Secondary outcomes in the mothers were point prevalence abstinence, time to smoking relapse, withdrawal symptoms, blood pressure, and alcohol and cannabis use in past 30 days. Secondary outcomes in the babies were gestational age at birth, birth characteristics (birth weight, length, head circumference, Apgar score), and a poor neonatal outcome-a composite measure of transfer to the neonatal unit, congenital malformation, convulsions, or perinatal death.ResultsMean age was 29 years. In the financial incentives and control groups, respectively, 137 (59%) and 148 (65%) were employed, 163 (71%) and 171 (75%) were in a relationship, and 41 (18%) and 31 (13%) were married. The participants had smoked a median of 60 cigarettes in the past seven days. The continuous abstinence rate was significantly higher in the financial incentives group (16%, 38/231) than control group (7%, 17/229): odds ratio 2.45 (95% confidence interval 1.34 to 4.49), P=0.004). The point prevalence abstinence rate was higher (4.61, 1.41 to 15.01, P=0.011), the median time to relapse was longer (visit 5 (interquartile range 3-6) and visit 4 (3-6), P<0.001)), and craving for tobacco was lower (β=-1.81, 95% confidence interval -3.55 to -0.08, P=0.04) in the financial incentives group than control group. Financial incentives were associated with a 7% reduction in the risk of a poor neonatal outcome: 4 babies (2%) in the financial incentives group and 18 babies (9%) in the control group: mean difference 14 (95% confidence interval 5 to 23), P=0.003. Post hoc analyses suggested that more babies in the financial incentives group had birth weights ≥2500 g than in the control group: unadjusted odds ratio 1.95 (95% confidence interval 0.99 to 3.85), P=0.055; sex adjusted odds ratio 2.05 (1.03 to 4.10), P=0.041; and sex and prematurity adjusted odds ratio 2.06 (0.90 to 4.71), P=0.086. As these are post hoc analyses, the results should be interpreted with caution.ConclusionsFinancial incentives to reward smoking abstinence compared with no financial incentives were associated with an increased abstinence rate in pregnant smokers. Financial incentives dependent on smoking abstinence could be implemented as a safe and effective intervention to help pregnant smokers quit smoking.Trial registrationClinicalTrials.gov NCT02606227.

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