Title: Evaluating the effectiveness of the alcohol reduction smartphone app, Drink Less, compared with the NHS alcohol advice webpage, for the reduction of alcohol consumption among hazardous and harmful drinkers in the UK at six-month follow-up: a randomised controlled trial
Funder: Department of Health and Social Care

Abstract: This research aims to evaluate whether recommending the improved version of Drink Less is effective and cost-effective for helping hazardous and harmful drinkers to reduce their alcohol consumption._x000D_ _x000D_ Hazardous and harmful alcohol consumption is a leading cause of avoidable deaths, ill-health, disability, and cancer in the UK. Health practitioners can help people to cut down by regularly asking about drinking and offering advice. Unfortunately, less than 1 in 10 hazardous and harmful drinkers in England receive this help due to barriers such as lack of time. Using digital technology, such as smartphone apps, provides support that can overcome these barriers and has the added advantages of being widely accessible and available. Health inequalities are a particular concern with regards to alcohol consumption as the most deprived groups in society suffer the most alcohol-related harm. Digital interventions have the potential to reduce health inequalities and help disadvantaged groups when designed with input from these user groups. A recent review of apps to help people reduce their drinking available on UK App Stores showed that none were based on scientific evidence or theory. _x000D_ _x000D_ The app, Drink Less, was developed to help people reduce their alcohol consumption using a systematic and iterative process drawing on evidence and theory to inform its content. The app consists of multiple modules with users being prompted to track their drinks and set goals, provided with feedback on their goals and how their drinking compares with others in the UK, as well as information on the UK drinking guidelines and links for additional support. Drink Less, available on the UK App Store since 2016, has accumulated over 50,000 users. Its evaluation in a preliminary trial assessed the effectiveness of individual modules, allowing us to understand which modules were helping users to reduce their alcohol consumption. Based on these findings and user feedback, the app has been updated and improved._x000D_ _x000D_ A randomised controlled trial will be conducted in which participants will be randomly recommended either the improved version of the Drink Less app or the NHS webpage with alcohol advice. The trial will be conducted online with adults (aged 18+) in the UK who consume hazardous or harmful levels of alcohol. Participants will be followed-up via email with a survey on their drinking behaviour using validated measures at one, three and six months. The study findings will indicate whether investment in promoting the app is warranted._x000D_ _x000D_ Patient and public involvement (PPI) has informed the research plans and will continue throughout this project including: preparing recruitment adverts, information and consent forms; providing feedback on using Drink Less; analysing and interpreting findings, and dissemination. _x000D_ _x000D_ The research outcomes will be disseminated through: links with Public Health England; press releases; conferences; publications in peer-reviewed journals; blog posts co-written with a PPI member on relevant organisations websites (e.g. Cancer Research UK, Society for Study of Addiction, Alcohol Change UK), and through the Alcohol Discussion Group in Stirling. A workshop will be hosted in central London on completion of the trial to engage with stakeholders.

Lay abstract: Research question_x000D_ At a 6-month follow-up, does the digital recommendation to use Drink Less compared with the NHS alcohol advice webpage to hazardous and harmful drinkers reduce alcohol consumption over the previous week?_x000D_ _x000D_ Background_x000D_ Alcohol consumption is a leading cause of avoidable morbidity and mortality in the UK. Digital technologies, such as smartphone apps, can overcome barriers to receiving brief interventions. A recent Cochrane review found that digital (primarily web-based) alcohol interventions are effective at reducing alcohol consumption but that were no randomised controlled trials (RCTs) of apps conducted in the UK. Drink Less is an app to help people reduce their alcohol consumption with over 50,000 unique users. It was developed using a systematic and iterative process drawing on evidence and theory. The app has been optimised based on the findings from an initial factorial trial (that assessed the effectiveness of five intervention modules), user feedback and further user testing with input from disadvantaged groups to ensure that Drink Less is acceptable, usable and effective across the social spectrum._x000D_ _x000D_ Aim_x000D_ To evaluate whether recommending Drink Less to individuals is more effective for the reduction of alcohol consumption compared with usual digital care._x000D_ _x000D_ Methods_x000D_ A two-armed RCT comparing the effectiveness and cost-effectiveness of offering hazardous and harmful drinkers the Drink Less app (intervention) or the NHS alcohol advice webpage (control). The primary outcome is change in self-reported alcohol consumption over the previous week. Secondary outcome measures are proportion of hazardous drinkers; alcohol-related problems and injury; health-related quality of life, and use of health services. Outcomes will be measured by follow-up questionnaires at 1, 3 and 6-months. A sample size of 5562 participants is required to detect a reduction of 2 UK units of alcohol at 90% power. The primary analysis will use a conservative intention-to-treat approach with the assumption of no change for non-responders. Main effects on primary will be examined using one-way ANCOVAs, adjusting for baseline alcohol consumption. The mixed-methods process evaluation will assess engagement, acceptability and the mechanisms of action. Separate economic evaluations will be conducted using a short-term time horizon based on within-trial data and a longer-term time horizon using a prospective modelling approach with the Sheffield Alcohol Policy Model._x000D_ _x000D_ Timelines for delivery_x000D_ The trial will run for 36 months. Recruitment will last 21 months and will be reviewed after 6 months by the trial steering committee._x000D_ _x000D_ Anticipated impact and dissemination_x000D_ This will be the first RCT of an app to reduce hazardous and harmful alcohol consumption for the general population in the UK and will provide evidence on the effectiveness and cost-effectiveness of the Drink Less app. We will submit at least four publications to high-impact peer-reviewed journals, communicate via conference presentations, press releases and blog posts, and follow the principles of Open Science. The research team includes a PHE partner, and has established relationships with key alcohol organisations, journalists and local authorities. We will commission an outline business plan to ensure that Drink Less is financially sustainable, and to maximise its future impact. The Drink Less app, if effective, will be in a strong position to be promoted widely, therefore increasing the number of hazardous and harmful drinkers supported to reduce their alcohol consumption at a low incremental cost.

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