Background and Aims: Digital interventions are effective for reducing alcohol consumption but evidence is limited regarding smartphone apps. Drink Less is a theory- and evidence-informed app to help people reduce their alcohol consumption that has been refined in terms of its content and design for usability across the sociodemographic spectrum. We aim to evaluate the effectiveness and cost-effectiveness of recommending Drink Less at reducing alcohol consumption compared with usual digital care. Design: Two-arm individually randomised controlled trial. Setting: Online trial in the United Kingdom (UK). Participants: Hazardous or harmful drinkers (Alcohol Use Disorders Identification Test [AUDIT] score ≥8) aged 18+ who want to drink less alcohol (n = 5562). Participants will be recruited from July 2020 to May 2022 using multiple strategies with a focus on remote digital methods. Intervention and comparator: Participants will be randomised to receive either an email recommending that they use Drink Less (intervention) or view the National Health Service (NHS) webpage on alcohol advice (comparator). Measurements: The primary outcome is change in self-reported weekly alcohol consumption, assessed using the extended AUDIT-Consumption, between baseline and 6-month follow-up. Secondary outcomes include change in self-reported weekly alcohol consumption assessed at 1- and 3-month follow-ups, and the proportion of hazardous drinkers; alcohol-related problems and injury; health-related quality of life; and use of health services assessed at 6-month follow-up. Effectiveness will be examined with adjusted regression models, adjusting for baseline alcohol consumption and using an intention-to-treat approach. A mixed-methods process evaluation will assess engagement, acceptability and mechanism of action. Economic evaluations will be conducted using both a short- and longer-term time horizon. Comments: This study will establish the effectiveness and cost-effectiveness of the Drink Less app at reducing alcohol consumption among hazardous and harmful adult drinkers and will be the first randomised controlled trial of an alcohol reduction app for the general population in the United Kingdom. This study will inform the decision on whether it is worth investing resources in large-scale implementation.
Bibliographical noteFunding Information:
C.G., E.P., M.M., M.F., M.O., G.L. and S.M. have no conflicts of interest in undertaking this research. J.B. and E.B. have received unrestricted funding related to smoking cessation research. J.B. sits on the scientific advisory board for the SmokeFree app. M.H. has received unrestricted speaker fees in the last 5 years from MSD, Gillead, Abbvie unrelated to this project. E.K. led two Cochrane Collaboration reviews in the field of screening and brief alcohol interventions including digital interventions and is currently leading an NIHR School of Public Health Research project that involves a network meta‐analysis bringing together both bodies of evidence. M.F. received funding from Alcohol Change UK in 2019 to conduct a rapid evidence review of digital interventions for the reduction of alcohol‐related harm. F.G. is employed by both PHE and Imperial. R.B. is a visiting researcher at King's College London and the Universityv of Southampton and has done consultancy for WHO Europe. C.A. has received funding for commissioned research from Systembolaget, the Swedish government‐owned alcohol retail monopoly and Alko (the Finnish equivalent).
We would like to thank Dr. Dave Crane for his important role in the development and factorial screening trial of the Drink Less app. This project is funded by the National Institute for Health Research (NIHR) (Public Health Research Programme; project reference NIHR127651). The views expressed are those of the author(s) and not necessarily those of the National Institute for Health Research or the Department of Health and Social Care, or Public Health England (PHE). C.G., E.B. and J.B. are also funded by Cancer Research UK (CRUK: C1417/A22962). Drink Less was funded by the NIHR School for Public Health Research (SPHR), the UK Centre for Tobacco and Alcohol Studies (UKCTAS), the Society for the Study of Addiction (SSA) and CRUK. E.P. is supported by the NIHR ARC North Thames. M.H. acknowledges NIHR Health Protection Research Unit in Evaluation, and M.M. and M.H. acknowledge NIHR Biomedical Research Centre at Bristol. J.B. and M.M. are part of the SPECTRUM Consortium, UK. The funders played no role in the design, conduct or analysis of the study, nor in the interpretation or reporting of study findings.
- Alcohol reduction
- behaviour change
- smartphone app