Title: Reducing binge drinking among disadvantaged men through a brief intervention delivered by mobile phone: a multi-centre randomised controlled trial
Funder: Chief Scientist Office (Scotland)

Abstract: Design: The study is a four centre parallel group randomised controlled trial. The components of the study were developed and tested in a feasibility study.Target population: Men aged 25-44 years living in areas of high deprivation who have had two or more episodes of binge drinking (>8 units in a single session) in the preceding month. To ensure good coverage of disadvantaged men two recruitment strategies will be used: through primary care and by community outreach. Intervention: The intervention is a series of Short Message Service (SMS) delivered by mobile phone. The intervention is based on effective empirical studies on alcohol and text message interventions. It employs theoretical models of behaviour change particularly the Health Action Process Approach and incorporates techniques from Motivational Interviewing and Communication Theory. The messages were constructed to take advantage of the conventional pattern of heavy weekend drinking: before weekend drinking after a heavy drinking episode and midweek sobriety. Messages are tailored to the drinking culture of disadvantaged young men and use popular texting terms and abbreviations. Techniques to increase message effectiveness include: use of gain-framed texts; pairing of messages; and inclusion of questions to promote interactivity. The text messages will be sent over a 12 week period and will deliver the behaviour change strategy in four stages. Stage 1 welcomes the men to the study establishes empathy and increases the salience of the short term harms of binge drinking. Stage 2 creates the intention to reduce binge drinking by highlighting the discrepancy between an individuals drinking habits (becoming drunk) and the intended aims of drinking (having fun and socialising). It will promote engagement with the benefits of moderated drinking and increase self-efficacy for refusing drinks. Stage 3 transforms intention into action by encouraging goal setting and the formation of action plans and coping plans. Stage 4 supports the maintenance of long term behaviour change. Outcome measures and duration of outcome: Outcomes will be assessed at 3 months and 12 months from the end of the intervention. The primary outcome measure is the frequency of binge drinking (consumption of >8 units in a single session) at 12 months. This outcome is particularly suitable for disadvantaged men: the feasibility study showed that most of the participants had regular episodes of binge drinking with periods of complete abstinence in between. The frequency of binge drinking at 3 months will assess the short term impact of the intervention. The Fast Alcohol Screening Test (FAST) will be used to determine the frequency of hazardous drinking. Total consumption of alcohol will be measured to ensure comparability with previous brief intervention trials. Sample size: The sample size is 798 men. The feasibility study showed that 57% of men had 3 or more binge drinking sessions in the previous 30 days. We aim to detect a reduction in the proportion of men drinking in this way from 57% to 46% a net reduction of 11% (as significance at p=0.05 with a power of 80%). A recent systematic review of conventional brief interventions found an 11% difference in frequency of binge drinking between intervention and control. The sample size allows for a 20% loss to follow-up. We expect that the loss to follow-up will be less than this as the loss in our three month feasibility study was only 4%. However as most alcohol brief intervention trials have a loss to follow-up at 12 months of over 20% it is prudent to make suitable allowance. Planned analyses: The effect size of the primary outcome will be presented as proportions odds ratios and 95% confidence intervals. The secondary outcomes will be assessed in a similar way. Further analyses will use logistic regression to explore which of the cognitive antecedents of behaviour change predict change in the primary outcome. The analysis will also explore whether the recruitment method (through primary care or community outreach) influences treatment effect. Project timetable: Months 1-2: Trial manager induction. Obtain for ethical permission. Establish the steering committee and register the trial. Months 3-8: Conduct fieldwork for recruitment. Update the text messages the computer programme for intervention delivery and the questionnaires. Prepare for the economic evaluation. Train research staff. Months 9-18: Screen disadvantaged men to recruit 798 in total. Conduct baseline interviews. Randomise. Deliver the intervention. Months 15-24: Conduct three month post-intervention delivery follow-up interviews. Months 24-33: Conduct twelve month post-intervention follow-up interviews. Months 34-39: Analysis report preparation and dissemination. Prepare papers for publication.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: STROKE;CANCER AND NEOPLASMS;CARDIOVASCULAR;ORAL AND GASTROINTESTINAL