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Aims To test the effectiveness of a theoretically based text‐message intervention to reduce binge drinking among socially disadvantaged men. Design A multi‐centre parallel group, pragmatic, individually randomized controlled trial. Setting Community‐based study conducted in four regions of Scotland. Participants A total of 825 men aged 25–44 years recruited from socially disadvantaged areas who had two or more episodes of binge drinking (> 8 UK units on a single occasion) in the preceding 28 days: 411 men were randomized to the intervention and 414 to the control. Intervention and comparator A series of 112 interactive text messages was delivered by mobile phone during a 12‐week period. The intervention was structured around the Health Action Process Approach, a comprehensive model which allows integration of a range of evidence‐based behaviour change techniques. The control group received 89 texts on general health, with no mention of alcohol or use of behaviour change techniques. Measurements The primary outcome measure was the proportion of men consuming > 8 units on three or more occasions (in the previous 28 days) at 12 months post‐intervention. Findings The proportion of men consuming > 8 units on three or more occasions (in the previous 28 days) was 41.5% in the intervention group and 47.8% in the control group. Formal analysis showed that there was no evidence that the intervention was effective [odds ratio (OR) = 0.79, 95% confidence interval (CI) = 0.57–1.08; absolute reduction 5.7%, 95% CI = −13.3 to 1.9]. The Bayes factor for this outcome was 1.3, confirming that the results were inconclusive. The retention was high and similar in intervention (84.9%) and control (86.5%) groups. Most men in the intervention group engaged with the text messages: almost all (92%) replied to text messages and 67% replied more than 10 times. Conclusions A theoretically based text‐messaging intervention aimed at reducing binge drinking in disadvantaged men was not found to reduce prevalence of binge drinking at 12‐month follow‐up.

Background: Socially disadvantaged men are more likely to binge drink frequently and to experience high levels of alcohol-related harm. Objectives: To test the effectiveness and cost-effectiveness of a text message intervention in reducing the frequency of binge drinking among disadvantaged men. Study design: A four-centre, parallel-group, pragmatic, individually randomised controlled trial was conducted. Randomisation was carried out using a secure remote web-based system. It was stratified by participating centre and recruitment method and restricted using block sizes of randomly varying lengths. Setting: The study was conducted in the community. Members of the public helped to develop the study methods. Participants: Participants were men aged 25–44 years who had ≥ 2 episodes of binge drinking (> 8 units of alcohol in a single session) in the preceding 28 days. Men were recruited from areas of high deprivation. Interventions: An empirically and theoretically based text message intervention was delivered by 112 interactive text messages over a 12-week period. The control group received an attentional control comprising 89 text messages on general health. Primary outcome measure: The primary outcome measure was the proportion of men consuming > 8 units of alcohol on ≥ 3 occasions (in the previous 28 days) at 12 months post intervention. Results: The recruitment target of 798 was exceeded and 825 men were randomised. Retention was high and similar in the intervention (84.9%) and control (86.5%) groups. Most men in the intervention group engaged enthusiastically with the text messages: almost all (92%) replied to text messages and over two-thirds (67%) replied more than 10 times. The intervention was estimated to have had a modest, statistically non-significant effect on the primary outcome at the 12-month follow-up [odds ratio 0.79, 95% confidence interval (CI) 0.57 to 1.08]. This corresponds to a net reduction of 5.7% in regular binge drinking. Five secondary outcomes showed small non-significant and inconsistent effects on alcohol consumption, with one suggesting a positive effect and four suggesting an adverse effect. Both the shortand the long-term cost per quality-adjusted life-year (QALY) analysis suggested that the brief intervention was dominated by a ‘do-nothing’ option. The intervention’s impacts on patterns of alcohol consumption, QALYs and downstream costs were inconsistent and uncertain. Limitations: The study used an active control that, combined with the recruitment procedures and baseline assessments, could have biased the treatment effect towards the null. The measurement of alcohol consumption relied on self-reported drinking. Conclusions: The trial has demonstrated that it is possible to recruit and retain large numbers of socially disadvantaged men in a research study. The text messages delivered a complex theoretically and empirically based intervention that fostered enthusiastic engagement with the key components of the behaviour change sequence. The intervention produced a modest, statistically non-significant effect on the primary outcome, with wide CIs. Further research is needed to reduce uncertainty about the treatment effect. The methods developed for this study provide a platform for the design and testing of interventions to reduce inequalities in health. Future work: A future trial could reduce the uncertainty around the treatment effect of the intervention. Trial registration: Current Controlled Trials ISRCTN07695192. Funding: This study was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 6, No. 6. See NIHR Journals Library website for further information.

Background Obese men who consume alcohol are at a greatly increased risk of liver disease; those who drink > 14 units of alcohol per week have a 19-fold increased risk of dying from liver disease. Objectives To develop an intervention to reduce alcohol consumption in obese men and to assess the feasibility of a randomised controlled trial (RCT) to investigate its effectiveness. Design of the intervention The intervention was developed using formative research, public involvement and behaviour change theory. It was organised in two phases, comprising a face-to-face session with trained laypeople (study co-ordinators) followed by a series of text messages. Participants explored how alcohol consumption contributed to weight gain, both through direct calorie consumption and through its effect on increasing food consumption, particularly of high-calorie foodstuffs. Men were encouraged to set goals to reduce their alcohol consumption and to make specific plans to do so. The comparator group received an active control in the form of a conventional alcohol brief intervention. Randomisation was carried out using the secure remote web-based system provided by the Tayside Clinical Trials Unit. Randomisation was stratified by the recruitment method and restricted using block sizes of randomly varying lengths. Members of the public were involved in the development of all study methods. Setting Men were recruited from the community, from primary care registers and by time–space sampling (TSS). The intervention was delivered in community settings such as the participant’s home, community centres and libraries. Participants Men aged 35–64 years who had a body mass index (BMI) of > 30 kg/m2 and who drank > 21 units of alcohol per week. Results The screening methods successfully identified participants meeting the entry criteria. Trial recruitment was successful, with 69 men (36 from 419 approached in primary care, and 33 from 470 approached via TSS) recruited and randomised in 3 months. Of the 69 men randomised, 35 were allocated to the intervention group and 34 to the control group. The analysis was conducted on 31 participants from the intervention group and 30 from the control group. The participants covered a wide range of ages and socioeconomic statuses. The average alcohol consumption of the men recruited was 47.2 units per week, more than twice that of the entry criterion (> 21 units per week). Most (78%) engaged in binge drinking (> 8 units in a session) at least weekly. Almost all (95%) exceeded the threshold for a 19-fold increase in the risk of dying from liver disease (BMI of > 30 kg/m2 and > 14 units of alcohol per week). Despite this, they believed that they were at low risk of harm from alcohol, possibly because they seldom suffered acute harms (e.g. hangovers) and made few visits to a general practitioner or hospital. Intervention The intervention was delivered with high fidelity. A high follow-up rate was achieved (98%) and the outcomes for the full RCT were measured. A process evaluation showed that participants engaged with the main components of the intervention. The acceptability of the study methods was high. Conclusions This feasibility study developed a novel intervention and evaluated all of the stages of a RCT that would test the effectiveness of the intervention. The main stages of a trial were completed successfully: recruitment, randomisation, intervention delivery, follow-up and measurement of study outcomes. Most of the men recruited drank very heavily and were also obese. This places them at a very high risk of liver disease, making them a priority for intervention. Future work A RCT to test the effectiveness and cost-effectiveness of the intervention. Trial registration Current Controlled Trials ISRCTN55309164.

INTRODUCTION AND AIMS: Disadvantaged men suffer substantial harm from heavy drinking. This feasibility study developed and evaluated the methods for a trial of a brief intervention delivered by text messages to disadvantaged men. It aimed to test the methods for recruitment and retention, to monitor engagement with the intervention and assess the overall acceptability of study methods.DESIGN AND METHODS: Disadvantaged men aged 25-44 years who had ≥2 episodes of binge drinking (≥8 units in one session) in the preceding month were recruited. Two recruitment strategies were assessed: recruitment from general practice registers and by a community outreach strategy. Theoretically and empirically based text messages were tailored to the target group.RESULTS: The study recruited 67 disadvantaged men at high risk of alcohol-related harm, exceeding the target of 60. Evaluation showed that 95% of text messages were delivered, and the men engaged enthusiastically with the intervention. Retention at follow up was 96%. Outcomes were successfully measured on all men followed up. This provided data for the sample size calculation for the full trial. Post-study evaluation showed high levels of satisfaction with the study.DISCUSSION AND CONCLUSIONS: This study has shown that disadvantaged men can be recruited and follow-up data obtained in an alcohol intervention study. The study methods were acceptable to the participants. The men recruited were at high risk of alcohol-related harms. It also clarified ways in which the recruitment strategy, the baseline questionnaire and the intervention could be improved. The full trial is currently underway. [Crombie IK, Irvine L, Falconer DW, Williams B, Ricketts IW, Jones C, Humphris G, Norrie J, Slane P, Rice P. Alcohol and disadvantaged men: A feasibility trial of an intervention delivered by mobile phone. Drug Alcohol Rev 2017;00:000-000].