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

Abstract Background Reducing the alcohol content of drinks has the potential to reduce alcohol consumption. Aims: (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), (2) provide data to estimate key parameters for a RCT. Methods 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: https://www.socialscienceregistry.org/trials/2266. Unique identifying number: AEARCTR-0002266.

Download Full-text

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

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00777-4 ◽

2021 ◽

Vol 7 (1) ◽

Cited By ~ 1

Author(s):

Parvati R. Perman-Howe ◽

Emma L. Davies ◽

David R. Foxcroft

Keyword(s):

Randomised Controlled Trial ◽

Alcohol Consumption ◽

Sample Size ◽

Study Protocol ◽

Controlled Trial ◽

Pilot Trial ◽

Recruitment Rate ◽

Participant Recruitment ◽

Licensed Premises ◽

Randomised Controlled

Abstract 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.

Download Full-text

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

10.21203/rs.3.rs-47586/v1 ◽

2020 ◽

Author(s):

Parvati Rose Perman-Howe ◽

Emma L Davies ◽

David R Foxcroft

Keyword(s):

Randomised Controlled Trial ◽

Alcohol Consumption ◽

Sample Size ◽

Study Protocol ◽

Controlled Trial ◽

Pilot Trial ◽

Recruitment Rate ◽

Participant Recruitment ◽

Licensed Premises ◽

Randomised Controlled

Abstract 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.

Download Full-text

Rethink My Drink : study protocol for a 12‐month randomised controlled trial comparing a brief internet‐delivered intervention to an online patient information booklet in reducing risky alcohol consumption among older adults in Australia

Addiction ◽

10.1111/add.15672 ◽

2021 ◽

Author(s):

Nicholas Hoy ◽

Nicola Newton ◽

Nicole A. Kochan ◽

Matthew Sunderland ◽

Andrew Baillie ◽

...

Keyword(s):

Older Adults ◽

Randomised Controlled Trial ◽

Alcohol Consumption ◽

Study Protocol ◽

Patient Information ◽

Controlled Trial ◽

Information Booklet ◽

Risky Alcohol ◽

Risky Alcohol Consumption ◽

Randomised Controlled

Download Full-text

A cluster randomised controlled trial of a comprehensive accreditation intervention to reduce alcohol consumption at community sports clubs: study protocol

BMJ Open ◽

10.1136/bmjopen-2011-000328 ◽

2011 ◽

Vol 1 (2) ◽

Cited By ~ 10

Author(s):

M. Kingsland ◽

L. Wolfenden ◽

B. C. Rowland ◽

J. Tindall ◽

K. E. Gillham ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Alcohol Consumption ◽

Study Protocol ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Sports Clubs ◽

Reduce Alcohol Consumption ◽

Cluster Randomised ◽

Community Sports ◽

Randomised Controlled

Download Full-text

Effectiveness of breathing exercises, foot reflexology and back massage (BRM) on labour pain, anxiety, duration, satisfaction, stress hormones and newborn outcomes among primigravidae during the first stage of labour in Saudi Arabia: a study protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-033844 ◽

2020 ◽

Vol 10 (6) ◽

pp. e033844

Author(s):

Kamilya Jamel Baljon ◽

Muhammad Hibatullah Romli ◽

Adibah Hanim Ismail ◽

Lee Khuan ◽

Boon How Chew

Keyword(s):

Saudi Arabia ◽

Randomised Controlled Trial ◽

Sample Size ◽

Study Protocol ◽

Human Subjects ◽

Controlled Trial ◽

Labour Pain ◽

Control Group ◽

Breathing Exercises ◽

Randomised Controlled

IntroductionLabour pain is among the severest pains primigravidae may experience during pregnancy. Failure to address labour pain and anxiety may lead to abnormal labour. Despite the many complementary non-pharmacological approaches to coping with labour pain, the quality of evidence is low and best approaches are not established. This study protocol describes a proposed investigation of the effects of a combination of breathing exercises, foot reflexology and back massage (BRM) on the labour experiences of primigravidae.Methods and analysisThis randomised controlled trial will involve an intervention group receiving BRM and standard labour care, and a control group receiving only standard labour care. Primigravidae of 26–34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal clinics. Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use. The BRM intervention will be delivered by a trained massage therapist. The primary outcomes of labour pain and anxiety will be measured during and after uterine contractions at baseline (cervical dilatation 6 cm) and post BRM hourly for 2 hours. The secondary outcomes include maternal stress hormone (adrenocorticotropic hormone, cortisol and oxytocin) levels, maternal vital signs (V/S), fetal heart rate, labour duration, Apgar scores and maternal satisfaction. The sample size is estimated based on the between-group difference of 0.6 in anxiety scores, 95% power and 5% α error, which yields a required sample size of 154 (77 in each group) accounting for a 20% attrition rate. The between-group and within-group outcome measures will be examined with mixed-effect regression models, time series analyses and paired t-test or equivalent non-parametric tests, respectively.Ethics and disseminationEthical approval was obtained from the Ethical Committee for Research Involving Human Subjects of the Ministry of Health in the Saudi Arabia (H-02-K-076-0319-109) on 14 April 2019, and from the Ethics Committee for Research Involving Human Subjects (JKEUPM) Universiti Putra Malaysia on 23 October 2019, reference number: JKEUPM-2019–169. Written informed consent will be obtained from all participants. Results from this trial will be presented at regional, national and international conferences and published in indexed journals.Trial registration numberISRCTN87414969, registered 3 May 2019.

Download Full-text