Irvine Linda, Crombie Iain K, Cunningham Kathryn B, Williams Brian, Sniehotta Falko F, Norrie John, Melson Ambrose J, Jones Claire, Rice Peter, Slane Peter W, Achison Marcus, McKenzie Andrew, Dimova Elena D, Allan Sheila
Division of Population Health Sciences, School of Medicine, University of Dundee, The Mackenzie Building, Kirsty Semple Way, Dundee, UK.
School of Health & Social Care, Edinburgh Napier University, Sighthill Campus, Sighthill Court, Edinburgh, UK.
Alcohol Alcohol. 2017 Nov 1;52(6):677-684. doi: 10.1093/alcalc/agx067.
Being obese and drinking more than 14 units of alcohol per week places men at very high risk of developing liver disease. This study assessed the feasibility of a trial to reduce alcohol consumption. It tested the recruitment strategy, engagement with the intervention, retention and study acceptability.
Men aged 35-64 years who drank >21 units of alcohol per week and had a BMI > 30 were recruited by two methods: from GP patient registers and by community outreach. The intervention was delivered by a face to face session followed by a series of text messages. Trained lay people (Study Coordinators) delivered the face to face session. Participants were followed up for 5 months from baseline to measure weekly alcohol consumption and BMI.
The recruitment target of 60 was exceeded, with 69 men recruited and randomized. At baseline, almost all the participants (95%) exceeded the threshold for a 19-fold increase in the risk of dying from liver disease. The intervention was delivered with high fidelity. A very high follow-up rate was achieved (98%) and the outcomes for the full trial were measured. Process evaluation showed that participants responded as intended to key steps in the behaviour change strategy. The acceptability of the study methods was high: e.g. 80% of men would recommend the study to others.
This feasibility study identified a group at high risk of liver disease. It showed that a full trial could be conducted to test the effectiveness and cost-effectiveness of the intervention.
Current controlled trials: ISRCTN55309164.
National Institute for Health Research Health Technology Assessment (NIHR HTA).
This feasibility study recruited 69 men at high risk of developing liver disease. The novel intervention, to reduce alcohol consumption through the motivation of weight loss, was well received. A very high follow-up rate was achieved. Process evaluation showed that participants engaged with key components of the behaviour change strategy.
男性肥胖且每周饮酒超过14单位会使其患肝病的风险极高。本研究评估了一项减少酒精摄入量试验的可行性。它测试了招募策略、对干预措施的参与度、留存率以及研究的可接受性。
通过两种方法招募年龄在35 - 64岁、每周饮酒超过21单位且BMI大于30的男性：从全科医生患者登记册中招募以及通过社区外展活动招募。干预措施通过一次面对面会议以及一系列短信来实施。经过培训的非专业人员（研究协调员）进行面对面会议。从基线开始对参与者进行5个月的随访，以测量每周的酒精摄入量和BMI。
招募人数超过了60人的目标，共招募并随机分配了69名男性。在基线时，几乎所有参与者（95%）都超过了因肝病死亡风险增加19倍的阈值。干预措施得到了高度忠实的实施。随访率非常高（98%），并对整个试验的结果进行了测量。过程评估表明，参与者对行为改变策略的关键步骤做出了预期反应。研究方法的可接受性很高：例如，80%的男性会向他人推荐该研究。
这项可行性研究确定了一个患肝病风险高的群体。它表明可以进行一项全面试验来测试干预措施的有效性和成本效益。
当前对照试验：ISRCTN55309164。
国家卫生研究院卫生技术评估（NIHR HTA）。
这项可行性研究招募了69名患肝病风险高的男性。通过减肥动机来减少酒精摄入量的新型干预措施受到了好评。随访率非常高。过程评估表明，参与者参与了行为改变策略的关键组成部分。
