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Benefits of temporary alcohol restriction: a feasibility randomized trial.
Pilot and Feasibility Studies ( IF 1.5 ) Pub Date : 2020-01-31 , DOI: 10.1186/s40814-020-0554-y
Matt Field 1 , Jo-Anne Puddephatt 2 , Laura Goodwin 2 , Lynn Owens 3 , Danielle Reaves 2 , John Holmes 4
Affiliation  

Background Participation in temporary alcohol abstinence campaigns such as 'Dry January' may prompt enduring reductions in alcohol consumption. A randomized controlled trial (RCT) is required to establish any long-term benefits or negative consequences of temporary abstinence. In the present study, we randomized heavy drinkers to complete or intermittent alcohol abstinence for 4 weeks, in order to evaluate the feasibility of conducting a large-scale RCT. Methods This was a mixed methods feasibility study in which we explored recruitment and retention to a randomized trial, compliance with alcohol abstinence instructions and barriers to compliance, and acceptability of study procedures (primary feasibility outcomes). A community sample of women aged between 40 and 60 who drank in excess of 28 alcohol units per week were randomized to abstain from alcohol for 4 weeks either completely or intermittently (at least four abstinent days per week). To monitor compliance, both groups provided regular breath samples on a cellular breathalyser. A subsample completed a semi-structured interview that probed barriers to compliance with abstinence instructions and acceptability of study procedures. Results Within 5 months, we recruited, screened and randomized 25 participants (20% of participants who responded to advertisements: 14 in the complete abstinence group, 11 in the intermittent abstinence group), 24 of whom were retained throughout the 28-day intervention period. Participants in both groups tended to comply with the instructions: the median number of breathalyser-verified abstinent days was 24 (IQR = 15.5-25.0; 86% of target) in the complete abstinence group versus 12 (IQR = 10-15; 75% of target) in the intermittent abstinence group. Semi-structured interviews identified some barriers to compliance and methodological issues that should be considered in future research. No adverse events were reported. Conclusions It is feasible to recruit heavy drinking women from community settings and randomize them to either complete or intermittent abstinence from alcohol for 4 weeks. The majority of participants were retained in the study and compliance with the abstinence instructions was good, albeit imperfect. A comprehensive RCT to compare temporary alcohol abstinence with other alcohol reduction strategies on long-term alcohol consumption is feasible. Findings from such a trial would inform implementation of alcohol campaigns and interventions.

中文翻译:

暂时限制饮酒的好处:一项可行性随机试验。

背景 参加“禁酒一月”等临时戒酒活动可能会促使酒精消费量持续减少。需要进行随机对照试验(RCT)来确定暂时禁欲的任何长期益处或负面后果。在本研究中,我们将重度饮酒者随机分为完全或间歇性戒酒4周,以评估进行大规模随机对照试验的可行性。方法 这是一项混合方法的可行性研究,其中我们探讨了随机试验的招募和保留、对戒酒指令的遵守情况和遵守障碍以及研究程序的可接受性(主要可行性结果)。社区样本中年龄在 40 岁至 60 岁之间、每周饮酒超过 28 个酒精单位的女性被随机分为完全戒酒或间歇戒酒 4 周(每周至少戒酒 4 天)。为了监测依从性,两组人员在细胞呼吸分析仪上定期提供呼吸样本。子样本完成了半结构化访谈,探讨了遵守禁欲指示的障碍和研究程序的可接受性。结果 5 个月内,我们招募、筛选和随机化了 25 名参与者(对广告做出反应的参与者的 20%:完全戒断组 14 名,间歇性戒断组 11 名),其中 24 名在整个 28 天的干预期内保留。两组参与者都倾向于遵守指示:完全戒酒组经呼气分析仪验证的戒酒天数中位数为 24 天(IQR = 15.5-25.0;目标的 86%),而完全戒酒组为 12 天(IQR = 10-15;75%)间歇性禁欲组中的目标)。半结构化访谈确定了未来研究中应考虑的一些合规障碍和方法问题。没有不良事件的报告。结论 从社区招募酗酒女性并将她们随机分为完全戒酒或间歇戒酒 4 周是可行的。大多数参与者都保留在研究中,并且对禁欲指示的遵守情况良好,尽管不完美。一项全面的随机对照试验来比较临时戒酒与其他饮酒策略对长期饮酒的影响是可行的。此类试验的结果将为酒精运动和干预措施的实施提供信息。
更新日期:2020-04-22
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