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Study protocol: a stepped wedge cluster randomised controlled trial of a healthy lifestyle intervention for people attending residential substance abuse treatment

机译:研究方案:一项针对参加居民滥用药物治疗的人们的健康生活方式干预措施的阶梯楔形聚类随机对照试验

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Background Cardiovascular disease and cancer are leading causes of mortality for people with a history of alcohol or other substance use disorders. These chronic diseases share the same four primary behavioural risk factors i.e. excessive alcohol use, smoking, low intake of fruit and vegetables and physical inactivity. In addition to addressing problematic alcohol use, there is the potential for substance abuse treatment services to also address these other behaviours. Healthy Recovery is an 8-session group-based intervention that targets these multiple behavioural health risk factors and was developed specifically for people attending substance abuse treatment. This protocol describes a Cancer Institute NSW funded study that assesses the effectiveness of delivering Healthy Recovery for people who are attending residential alcohol and other substance abuse treatment. Methods/Design The study uses a stepped wedge randomised controlled design, where randomisation occurs at the service level. Participants will be recruited from residential rehabilitation programs provided by The Australian Salvation Army. All participants who (1) currently smoke tobacco and (2) are expected to be in the residential program for the duration of the 5-week intervention will be asked to participate in the study. Those participants residing at the facilities assigned to the treatment condition will complete Healthy Recovery. The intervention is manual guided and will be delivered over a 5-week period, with participants attending 8 group sessions. All participants will continue to complete The Salvation Army residential program, a predominantly 12-step based, modified therapeutic community. Participants in the control condition will complete treatment as usual. Research staff blind to treatment allocation will complete the primary and secondary outcome assessments at baseline and then at weeks 8, 20 and 32?weeks post intervention. Discussion This study will provide comprehensive data on the effect of delivering a healthy lifestyle intervention (i.e. Healthy Recovery) within a residential substance abuse setting. If shown to be effective, this intervention can be disseminated within other residential substance abuse programs. Trial registration Australian and New Zealand Clinical Trials Register (ANZCTR): ACTRN12615000165?583 . Registered 19th February 2015.
机译:背景技术心血管疾病和癌症是有酒精或其他药物滥用史的人的主要死亡原因。这些慢性病具有相同的四个主要的行为危险因素,即过量饮酒,吸烟,水果和蔬菜摄入少以及缺乏运动。除了解决有问题的饮酒问题外,药物滥用治疗服务还有可能解决其他这些行为。 Healthy Recovery是一项基于8个小组的干预措施,针对这些多种行为健康风险因素,是专门为参加药物滥用治疗的人们而开发的。该协议描述了由新南威尔士州癌症研究所资助的一项研究,该研究评估了正在接受居住性酒精和其他药物滥用治疗的人们提供“健康康复”的有效性。方法/设计本研究使用分步楔形随机控制设计,其中随机发生在服务级别。参加者将从澳大利亚救世军提供的住宅康复计划中招募。将要求所有(1)当前吸烟和(2)在为期5周的干预期间参加住院治疗计划的参与者。居住在分配了治疗条件的设施中的那些参与者将完成健康恢复。干预是人工指导的,将在5周内进行,参与者参加8个小组会议。所有参与者将继续完成救世军的住宿计划,该计划主要是基于12个步骤的改良治疗社区。处于控制状态的参与者将照常完成治疗。不了解治疗方案的研究人员将在基线,干预后第8、20和32周时完成主要和次要结果评估。讨论本研究将提供有关在居民滥用药物的环境中提供健康的生活方式干预措施(即健康恢复)效果的综合数据。如果证明有效,则可以在其他居民滥用药物计划中传播这种干预措施。试验注册澳大利亚和新西兰临床试验注册(ANZCTR):ACTRN12615000165?583。 2015年2月19日注册。

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