The effect of alcohol strength on alcohol consumption: a randomised controlled cross-over pilot trial

Background 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. Methods 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. Results 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). Conclusion 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. Trial registration Registered in the American Economic Association (AEA) Randomised Controlled Trial (RCT) Registry as of 16 June 2017. Unique identifying number: AEARCTR-0002266.

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“…The primary outcome was the feasibility of a RCT. A RCT was deemed feasible if it met the following prespecified criteria [32]:…”

Section: Feasibility Criteriamentioning

confidence: 99%

“…According to the study protocol, a RCT would be deemed feasible if the pilot study met six criteria for success [32].…”

Section: Outcomes and Estimationmentioning

confidence: 99%

The effect of alcohol strength on alcohol consumption: findings from a randomised controlled cross-over pilot trial

Perman-Howe

Davies

Foxcroft

2021

Pilot Feasibility Stud

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“…The primary outcome was the feasibility of a RCT. A RCT was deemed feasible if it met the following pre-speci ed criteria [32]:…”

Section: Feasibility Criteriamentioning

confidence: 99%

The Effect of Alcohol Strength on Alcohol Consumption: Findings from A Randomised Controlled Cross-Over Pilot Trial.

Perman-Howe

Davies

Foxcroft

2020

Preprint

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Background Reducing the alcohol content of drinks has the potential to reduce population level alcohol consumption. This pilot study aimed 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 (2) provide data to estimate key parameters for a RCT. MethodsA double-blind randomised controlled cross-over pilot trial was based within four licensed premises in the UK. Participants (n=36) purchased and consumed ad libitum a 3.5% lager (intervention), and a taste matched 4.8% lager (control) 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 study 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.ResultsComponents of the study protocol were effective and efficient. The venue recruitment rate was less than anticipated whilst 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). Based on a conservative estimate, using the smallest effect size in the CI (-2.52) and allowing for 23% attrition, the sample size required for a RCT powered at 95% is 53. Participants did not find one lager notably more pleasant in taste than the other: (on a scale of one to 10) -0.95 (-2.11 to 0.21). However, participants found the reduced-strength lager notably less enjoyable than the regular-strength lager: (on a scale of one to 10) -1.44 (-2.64 to -0.24) and they perceived themselves to be notably less intoxicated after consuming the reduced-strength lager: (on a scale of one to 10) -1.00 (-1.61 to -0.40).ConclusionA RCT is feasible with minor alterations to the study protocol and prior scoping work to establish different brands of alcohol that are more alike and more enjoyable than the intervention and control products used in the pilot trial. Trial registrationThe trial is registered in the American Economic Association (AEA) Randomised Controlled Trial (RCT) Registry as of 16 June 2017: https://www.socialscienceregistry.org/trials/2266. The unique identifying number is: AEARCTR-0002266.

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“…In 2015, there were 8758 avoidable deaths in the UK that were directly caused by alcohol. Moreover, 2.5 million people who regularly drink alcohol report exceeding weekly alcohol thresholds in a single drinking occasion [23]. Alcohol is second only to tobacco as a cause of drug-related death and hospitalization, responsible for 5.1% of the total burden of disease and injury in Australia in 2011.…”

Section: Alcohol Consumption and Related Liver Diseasesmentioning

confidence: 99%

“…INDUCED LIVER DISEASES Both alcohol addiction and alcohol induced diseases, both have separate issues of economic burden. The financial burden of alcohol-related harm is estimated to annually cost UK society between 1.3 and 2.7% gross GDP [23]. Approximately 64,000,000 people in the US report binge drinking at least once in a single month of 2018 [32].…”

Section: Economical Burden Of Alcoholmentioning

confidence: 99%

Alcohol Induced Fatty Liver: A Tragic Inception of Wrong Turn

2019

ARC Journal of Nursing and Healthcare

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Alcohol is a noteworthy reason for liver cirrhosis in the Western world and records for most of instances of liver cirrhosis found in region general emergency clinics in the UK. Alcoholic liver disease is a term that incorporates the liver appearances of alcohol overconsumption, including fatty liver, alcoholic hepatitis, and constant hepatitis with liver fibrosis or cirrhosis. As per the American Liver Foundation (ALF), somewhere in the range of 10 and 20 percent of substantial consumers will develop cirrhosis. The disease is a piece of a progression. It might begin with fatty liver disease, at that point advancement to alcoholic hepatitis, and after that to alcoholic cirrhosis. Be that as it may, it's conceivable an individual can develop alcoholic liver cirrhosis while never having alcoholic hepatitis. Symptoms of alcoholic liver cirrhosis regularly develop when an individual is between the ages of 30 and 40. All things considered, it takes around one hour for the body to utilize (separate) one standard beverage as characterized by U.S. rules (for example 12 ounces of 4.5% brew, 5 ounces of 11% wine, or 1.5 ounces of 35% alcohol). Utilization of 60-80g every day (14g is viewed as one standard beverage in the US, i.e., 1.5 fl oz hard alcohol, 5 fl oz wine, 12 fl oz lager; drinking a six-pack of brew day by day would be amidst the range) for a long time or more in men, or 20g/day for ladies fundamentally builds the danger of hepatitis and fibrosis by 7% to 47%. Of all endless substantial consumers, just 15-20% develop hepatitis or cirrhosis, which can happen correspondingly or in progression. The purpose for is accepted to be the liver has gigantic ability to recover and notwithstanding when 75% of hepatocytes are dead, it keeps on working as should be expected. As indicated by NIAAA (1993), somewhere in the range of 10% and 35% of substantial consumers develop alcoholic hepatitis. While development of hepatitis isn't specifically identified with the portion of alcohol, a few people appear to be more prone to this response than others. This is called alcoholic steato-necrosis (Steatosis) and the inflammation seems to incline to liver fibrosis.

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The effect of alcohol strength on alcohol consumption: a randomised controlled cross-over pilot trial

Cited by 3 publications

References 21 publications

The effect of alcohol strength on alcohol consumption: findings from a randomised controlled cross-over pilot trial

The effect of alcohol strength on alcohol consumption: findings from a randomised controlled cross-over pilot trial

The Effect of Alcohol Strength on Alcohol Consumption: Findings from A Randomised Controlled Cross-Over Pilot Trial.

Alcohol Induced Fatty Liver: A Tragic Inception of Wrong Turn

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