Oldham, M., Beard, E., Loebenberg, G. et al. (12 more authors) (2024) Effectiveness of a smartphone app (Drink Less) versus usual digital care for reducing alcohol consumption among increasing-and-higher-risk adult drinkers in the UK: a two-arm, parallel-group, double-blind, randomised controlled trial. EClinicalMedicine, 70. 102534. ISSN 2589-5370
Abstract
Background
Digital interventions, including apps and websites, can be effective for reducing alcohol consumption. However, many are not evidence- or theory-informed and have not been evaluated. We tested the effectiveness of the Drink Less app for reducing alcohol consumption compared with usual digital care in the UK.
Methods
In this two-arm, parallel group, double-blind, randomised controlled trial, we enrolled increasing-and-higher-risk drinkers (AUDIT ≥ 8) in the UK, who were motivated to reduce their alcohol consumption and willing to use a digital intervention to do so, via online methods. Participants were randomly assigned (1:1), using an online algorithm, to receive a web link to download the Drink Less app (intervention) or to the NHS alcohol advice webpage (usual digital care). Researchers were masked to group allocation. Participants were followed up at one, three and six months. The primary outcome was self-reported weekly alcohol consumption at six months, adjusting for baseline consumption. The full analytic sample was used in most analyses, though missing data was treated in different ways. The primary, pre-registered intention-to-treat analysis assumed baseline-carried-forwards. Secondary pre-registered analyses also focused on the full analytic sample and used alternatives including multiple imputation and last observation carried forwards. This trial is registered with the ISRCTN registry, ISRCTN64052601.
Findings
Between 07/13/2020 and 03/29/2022, 5602 people were randomly assigned to the Drink Less app (n = 2788) or comparator (n = 2814) groups. Six-month follow-up rates were 79% and 80%, respectively. The primary pre-registered conservative intention-to-treat approach assuming non-responders were drinking at baseline levels of consumption, found a non-significant greater reduction of 0.98 units in weekly alcohol consumption in the intervention group at 6-month follow-up (95% CI −2.67 to 0.70). The data were insensitive to detect the hypothesised effect (Bayes factor = 1.17). Data were not missing completely at random, with 6-month follow-up rates differing in terms of education, occupation, and income. We therefore conducted the pre-registered sensitivity analysis using multiple imputation, showing that the Drink Less app resulted in a 2.00-unit greater weekly reduction at 6-month follow-up compared with the NHS alcohol advice webpage (95% CI −3.76 to −0.24). Fewer than 0.1% of participants in both arms who responded to one, three or six-month follow-up reported adverse events linked to participation in the trial.
Interpretation
The Drink Less app may be effective in reducing the alcohol consumption in increasing-and-higher-risk drinkers motivated to reduce their consumption.
Funding
NIHR Public Health Research Programme.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2024 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). |
Keywords: | Alcohol reduction app; MHealth; Randomised Controlled Trial; Drink Less; Digital Intervention |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Science (Sheffield) > Department of Psychology (Sheffield) |
Funding Information: | Funder Grant number DEPARTMENT OF HEALTH AND SOCIAL CARE NIHR127651 |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 28 Feb 2024 15:34 |
Last Modified: | 13 May 2024 12:39 |
Status: | Published |
Publisher: | Elsevier |
Refereed: | Yes |
Identification Number: | 10.1016/j.eclinm.2024.102534 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:209532 |