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      Brief intervention on Smoking, Nutrition, Alcohol and Physical (SNAP) inactivity for smoking relapse prevention after release from smoke-free prisons: a study protocol for a multicentre, investigator-blinded, randomised controlled trial

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          Abstract

          Introduction

          Smoking remains the leading risk factor for disease burden and mortality worldwide. Heavy Smoking is often associated with poor Nutrition, Alcohol abuse and Physical inactivity (known as ‘SNAP’). Australia’s first prison smoking ban was introduced in the Northern Territory in July 2013. However, relapse to smoking after release from prison is normative. Holistic and cost-effective interventions are needed to maintain post-release abstinence to realise the potential public health impact of smoke-free prison policies. Rigorous, large-scale trials of innovative and scalable interventions are crucial to inform tobacco control policies in correctional settings.

          Methods and analysis

          This multicentre, investigator-blinded, randomised parallel superiority trial will evaluate the effectiveness of a brief intervention on SNAP versus usual care in preventing smoking relapse among people released from smoke-free prisons in the Northern Territory, Australia. A maximum of 824 participants will be enrolled and randomly assigned to either SNAP intervention or usual care at a 1:1 ratio at baseline. The primary endpoint is self-reported continuous smoking abstinence three months after release from prison, verified by breath carbon monoxide test. Secondary endpoints include seven-day point prevalence abstinence, time to first cigarette, number of cigarettes smoked post release, Health Eating Index for Australian Adults, Alcohol Use Disorder Identification Test-Consumption and International Physical Activity Questionnaire scores. The primary endpoint will be analysed on an intention-to-treat basis using a simple log binomial regression model with multiple imputation for missing outcome data. A cost-effectiveness analysis of the brief intervention will be conducted subsequently.

          Ethics and dissemination

          This study was approved by the University of New South Wales Human Research Ethics Committee (HREC), Menzies HREC and Central Australia HREC. Primary results of the trial and each of the secondary endpoints will be submitted for publication in a peer-review journal.

          Trial registration number

          ACTRN12617000217303; Pre-results.

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          Most cited references31

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          Reliability and validity of a smoking timeline follow-back interview.

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            A tutorial on count regression and zero-altered count models for longitudinal substance use data.

            Critical research questions in the study of addictive behaviors concern how these behaviors change over time: either as the result of intervention or in naturalistic settings. The combination of count outcomes that are often strongly skewed with many zeroes (e.g., days using, number of total drinks, number of drinking consequences) with repeated assessments (e.g., longitudinal follow-up after intervention or daily diary data) present challenges for data analyses. The current article provides a tutorial on methods for analyzing longitudinal substance use data, focusing on Poisson, zero-inflated, and hurdle mixed models, which are types of hierarchical or multilevel models. Two example datasets are used throughout, focusing on drinking-related consequences following an intervention and daily drinking over the past 30 days, respectively. Both datasets as well as R, SAS, Mplus, Stata, and SPSS code showing how to fit the models are available on a supplemental website.
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              Randomized experiments in criminology: What have we learned in the last two decades?

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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2018
                18 October 2018
                : 8
                : 10
                : e021326
                Affiliations
                [1 ] departmentNational Drug and Alcohol Research Centre , University of New South Wales , Randwick, New South Wales, Australia
                [2 ] departmentThe Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders , The University of Sydney , Sydney, New South Wales, Australia
                [3 ] departmentCentre for Adolescent Health , Murdoch Children’s Research Institute , Melbourne, Victoria, Australia
                [4 ] departmentMelbourne School of Population and Global Health , University of Melbourne , Melbourne, Victoria, Australia
                [5 ] departmentMater Research Institute , University of Queensland , Brisbane, Queensland, Australia
                [6 ] departmentGriffith Criminology Institute , Griffith University , Brisbane, Queensland, Australia
                [7 ] departmentSchool of Public Health and Preventive Medicine , Monash University , Melbourne, Victoria, Australia
                [8 ] Northern Territory Correctional Services , Darwin, Northern Territory, Australia
                [9 ] departmentCentre for Health Economics , Monash University , Melbourne, Victoria, Australia
                Author notes
                [Correspondence to ] Dr Xingzhong Jin; xingzhong.jin@ 123456sydney.edu.au
                Author information
                http://orcid.org/0000-0003-4293-8665
                Article
                bmjopen-2017-021326
                10.1136/bmjopen-2017-021326
                6196819
                30341114
                00f3cb05-4136-45e9-9c31-9f64b04221cf
                © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 24 December 2017
                : 17 May 2018
                : 19 July 2018
                Funding
                Funded by: Australian Commonwealth Government Department of Health Tackling Indigenous Smoking Grant;
                Categories
                Smoking and Tobacco
                Protocol
                1506
                1734
                Custom metadata
                unlocked

                Medicine
                clinical trials,public health,health policy
                Medicine
                clinical trials, public health, health policy

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