JMIR Publications

ABSTRACT

Background:

Harmful use of alcohol continues to be a leading contributor to premature deaths globally. Not only does harmful drinking have consequences for the individuals consuming at increased levels, but it may also result in a range of negative consequences for their family members and friends. Interventions delivered via mobile phones, included in the umbrella term mHealth interventions, could potentially support risky drinkers seeking help to reduce their alcohol consumption. This protocol describes a randomized controlled trial that aims to validly estimate the effect of a novel mHealth intervention that is targeting risky drinkers in the general population of Sweden. Nested within the trial are three sub-studies that focus on methodological and user satisfaction research questions.

Objective:

This article is a protocol for a randomized controlled trial.

Methods:

A two-arm parallel group randomised controlled trial will be employed to estimate the effect of the novel intervention. Participants will be recruited through online advertisements and social media. Inclusion criteria are: being 18 years of age or older, ownership of a mobile phone, and being classified as a risky drinker according to Swedish guidelines. Note there is no upper limit to alcohol consumption as an exclusion criterion, meaning the study population is anticipated to comprise both harmful and hazardous drinkers. Participants allocated to the control group will receive a short text regarding short and long term negative consequences of alcohol consumption and a hyperlink which offers more information. The control group are given access to the newly developed mobile phone support tool that is evaluated in this study. The primary outcomes are weekly alcohol consumption and heavy episodic drinking. Apart from the main trial, we will also explore whether the mode of presenting information prior to participants giving informed consent affects participation rates and recall of trial parameters. Also, we will investigate if the content of the short text received by the control group affects study outcomes and requests for more information. Finally, we will explore user satisfaction with the intervention and the reactions of the control group.

Results:

Participant recruitment is planned to begin in March 2019, and to last for a maximum of 24 months. The first data set will be available approximately two months after the final participant has been recruited (recall of trial procedures), and the final data set will be available approximately two months later. No participants had been recruited at the time of submitting this protocol.

Conclusions:

If found effective, the intervention has the potential to reduce negative consequences of alcohol consumption for individuals. The technology has been designed to have potential for extensive reach among those who may benefit. Clinical Trial: This trial has been registered with ISRCTN on 06/12/2018 (ISRCTN48317451).