Perman-Howe Parvati R, Davies Emma L, Foxcroft David R
King's College London, Addiction Sciences Building, 4 Windsor Walk, Denmark Hill Campus, London, SE5 8BB, UK.
Oxford Brookes University, Gipsy Lane Campus, Gipsy Lane, Oxford, OX3 0BP, UK.
Pilot Feasibility Stud. 2021 Jan 30;7(1):37. doi: 10.1186/s40814-021-00777-4.
Reducing the alcohol content of drinks has the potential to reduce alcohol consumption. The aims of this study are to (1) test the feasibility of a randomised controlled trial (RCT) to assess the effect of alcohol strength on alcohol consumption within licensed premises in the United Kingdom (UK), and to (2) provide data to estimate key parameters for a RCT.
This study is a double-blind randomised controlled cross-over pilot trial based within four licensed premises in the UK. Participants (n = 36) purchased and consumed ad libitum a 3.5% lager and a 4.8% lager during two separate study sessions. Descriptive statistics reported the efficacy and efficiency of the study processes, and the rates of licensed premises recruitment, and participant recruitment and attrition. Mean and the 95% confidence interval (CI) compared alcohol consumption between conditions. The mean, standard deviation (SD) and CI of UK units of alcohol consumed were used to calculate a sample size for a RCT. Responses to participant questionnaires and duration of participation in study sessions between conditions were analysed.
Components of the study protocol were effective and efficient. The venue recruitment rate was less than anticipated. The participant recruitment rate was greater than anticipated. The rate of attrition was 23% and varied by less than 1% according to the arm of the trial. There was a reduction of alcohol consumed under the intervention conditions. Estimated mean difference, and 95% CI (UK units): - 3.76 (- 5.01 to - 2.52). The sample size required for a RCT is 53. Participants did not find one lager more pleasant in taste: (on a scale of one to 10) - 0.95 (- 2.11 to 0.21). Participants found the reduced-strength lager less enjoyable: (on a scale of one to 10) - 1.44 (- 2.64 to - 0.24) and they perceived themselves to be less intoxicated after consuming it: (on a scale of one to 10) - 1.00 (- 1.61 to - 0.40).
A RCT is feasible with minor alterations to the study protocol and scoping work to establish different brands of alcohol that are more alike and more enjoyable than the products used in the pilot trial.
Registered in the American Economic Association (AEA) Randomised Controlled Trial (RCT) Registry as of 16 June 2017. Unique identifying number: AEARCTR-0002266 .
降低饮品中的酒精含量有可能减少酒精摄入量。本研究的目的是:(1)测试一项随机对照试验(RCT)的可行性,以评估酒精浓度对英国持牌场所内酒精消费的影响;(2)提供数据以估算RCT的关键参数。
本研究是一项双盲随机对照交叉试点试验,在英国的四个持牌场所内进行。参与者(n = 36)在两个单独的研究时段内随意购买并饮用了酒精度为3.5%的淡啤酒和4.8%的淡啤酒。描述性统计报告了研究过程的有效性和效率、持牌场所的招募率以及参与者的招募和流失率。通过均值和95%置信区间(CI)比较不同条件下的酒精消费量。用英国酒精单位消费量的均值、标准差(SD)和CI来计算RCT的样本量。分析了参与者问卷的回答以及不同条件下参与研究时段的时长。
研究方案的各个组成部分有效且高效。场所招募率低于预期。参与者招募率高于预期。流失率为23%,根据试验组的不同,差异小于1%。在干预条件下,酒精消费量有所减少。估计平均差值及95%CI(英国单位):-3.76(-5.01至-2.52)。RCT所需的样本量为53。参与者并未觉得一种淡啤酒的口感更好(1至10分制):-0.95(-2.11至0.21)。参与者发现酒精度降低的淡啤酒没那么好喝(1至10分制):-1.44(-2.64至-0.24),并且他们认为饮用后自己的醉酒程度没那么高了(1至10分制):-1.00(-1.61至-0.40)。
对研究方案进行 minor alterations(此处原文可能有误,推测为minor alterations)并开展范围界定工作,以确定比试点试验中使用的产品更相似且更美味的不同品牌酒精,在此情况下进行RCT是可行的。
于2017年6月16日在美国经济协会(AEA)随机对照试验(RCT)注册库注册。唯一识别编号:AEARCTR - 0002266 。