Jin Xingzhong, Kinner Stuart A, Hopkins Robyn, Stockings Emily, Courtney Ryan J, Shakeshaft Anthony, Petrie Dennis, Dobbins Timothy, Dolan Kate
National Drug and Alcohol Research Centre, University of New South Wales, Randwick, New South Wales, Australia.
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, The University of Sydney, Sydney, New South Wales, Australia.
BMJ Open. 2018 Oct 18;8(10):e021326. doi: 10.1136/bmjopen-2017-021326.
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.
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.
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.
ACTRN12617000217303; Pre-results.
吸烟仍然是全球疾病负担和死亡率的首要风险因素。重度吸烟往往与营养不良、酗酒和缺乏身体活动（即“SNAP”）相关。2013年7月，澳大利亚北领地实施了该国首个监狱吸烟禁令。然而，出狱后复吸是常态。需要全面且具成本效益的干预措施来维持出狱后的戒烟状态，以实现无烟监狱政策的潜在公共卫生影响。开展严格、大规模的创新且可扩展干预措施试验对于为惩教机构的烟草控制政策提供依据至关重要。
这项多中心、研究者设盲、随机平行优效性试验将评估一种针对SNAP的简短干预措施与常规护理相比，在预防澳大利亚北领地无烟监狱释放人员吸烟复发方面的有效性。最多将招募824名参与者，并在基线时按1:1的比例随机分配至SNAP干预组或常规护理组。主要终点是出狱三个月后自我报告的持续戒烟情况，通过呼气一氧化碳测试进行验证。次要终点包括七天时点戒烟率、首次吸烟时间、出狱后吸烟数量、澳大利亚成年人健康饮食指数、酒精使用障碍识别测试-消费版得分以及国际体力活动问卷得分。主要终点将采用简单对数二项回归模型，对缺失的结局数据进行多重插补，基于意向性分析原则进行分析。随后将对该简短干预措施进行成本效益分析。
本研究已获新南威尔士大学人类研究伦理委员会（HREC）、孟席斯HREC和澳大利亚中部HREC批准。试验的主要结果以及每个次要终点将提交至同行评审期刊发表。
ACTRN12617000217303；预结果。
