Dataset Information

Reducing Alcohol Consumption Among Risky Drinkers in the General Population of Sweden Using an Interactive Mobile Health Intervention: Protocol for a Randomized Controlled Trial.

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 (mobile health [mHealth] interventions) could potentially support risky drinkers seeking help to reduce their alcohol consumption.

Objective

This protocol describes a randomized controlled trial that aims to validly estimate the effect of a novel mHealth intervention targeting risky drinkers in the general population of Sweden. Nested within the trial are 3 substudies that focus on methodological and user satisfaction research questions.

Methods

A 2-arm parallel group randomized controlled trial will be employed to estimate the effect of the novel intervention. Participants will be recruited through Web advertisements and social media. The inclusion criteria are as follows: 18 years or older, ownership of a mobile phone, and being classified as a risky drinker according to Swedish guidelines. Participants allocated to the intervention group will receive a novel mHealth intervention. The intervention consists of weekly screening, personalized feedback on current consumption, functions allowing for planning of future consumption, as well as a series of messages delivered throughout the week. Participants allocated to the control group will receive a short message regarding negative consequences of alcohol consumption and a hyperlink that offers more information. Following 2 and 4 months after randomization, both groups will be asked to complete follow-up questionnaires (2-month interval being primary). Primary outcomes are weekly alcohol consumption and heavy episodic drinking. Participants in the control group will be given access to the novel intervention after completing the 4-month follow-up. The trial includes 3 substudies: We will explore whether the mode of presenting information before participants giving informed consent affects participation rates and recall of trial parameters, investigate if the content of the short message received by the control group affects study outcomes and requests for more information, and explore user satisfaction with the intervention and reactions of the control group.

Results

Participant recruitment is planned to begin in April 2019 and to last for a maximum of 24 months. The first dataset will be available approximately 2 months after the final participant has been recruited, and the final dataset will be available approximately 2 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.

Trial registration

ISRCTN Registry ISRCTN48317451; http://www.isrctn.com/ISRCTN48317451 (Archived by WebCite at http://www.webcitation.org/779tKLsu3).

International registered report identifier (irrid)

PRR1-10.2196/13119.

SUBMITTER: Bendtsen M

PROVIDER: S-EPMC6495288 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Publications

Reducing Alcohol Consumption Among Risky Drinkers in the General Population of Sweden Using an Interactive Mobile Health Intervention: Protocol for a Randomized Controlled Trial.

Bendtsen Marcus M McCambridge Jim J

JMIR research protocols 20190418 4

<h4>Background</h4>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 (mobile health [mHealth] interventions) could potentially support risky drinkers seeking help to reduce their alcohol consumption.<h4>Objective</h4>Thi ...[more]

PMID: 30998221

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Project description:BackgroundRecent research has investigated the utility of mobile phone-delivered interventions for reducing risky single-occasion drinking, also known as binge drinking. In the past five years, focus has been placed on ecological momentary interventions (EMIs), which aim to deliver intervention content in correspondence to real-time assessments of behavior, also known as ecological momentary assessments (EMAs).ObjectiveThis study aims to assess the effect of a fully automated, tailored, mobile phone-delivered EMI termed Mobile Intervention for Drinking in Young people (MIDY) on young people's risky single-occasion drinking behavior.MethodsWe will use a three-armed randomized controlled trial design to determine the impact of MIDY on peak consumption of alcohol among young people. A list of mobile telephone numbers for random digit dialing will be generated, and researchers will telephone potential participants to screen for eligibility. Participants will be randomized into one of three intervention groups. For 6 weeks, EMI, EMA, and attention control groups will complete hourly EMA surveys on their mobile phones on Friday and Saturday nights. EMI participants will receive personalized feedback in the form of text messages corresponding to their EMA survey responses, which focus on alcohol consumption, spending, and mood. EMA participants will not receive feedback. A third group will also complete EMA and receive feedback text messages at the same time intervals, but these will be focused on sedentary behavior and technology use. All groups will also complete a short survey on Saturday and Sunday mornings, with the primary outcome measure taken on Sunday mornings. A more detailed survey will be sent on the final Sunday of the 6-week period, and then again 1 year after recruitment.ResultsThe primary outcome measure will be an observed change (ie, reduction) in the mean peak number of drinks consumed in a single night over the 6-week intervention period between the EMI and attention control groups as measured in the weekly EMA. We expect to see a greater reduction in mean peak drinking in the EMI group compared to that in the attention control group. As a secondary aim, we will assess whether mean peak drinking is reduced in the EMA group compared to the attention control group. We will use a random-effects mixed-modeling approach using maximum-likelihood estimation to provide estimates of differences in peak drinking across time periods between those receiving the intervention (EMI) and attention control participants. An intention-to-treat approach will be taken for the analysis. Individuals and study groups will be modeled as random and fixed factors, respectively.ConclusionsThis study extends our previous work investigating the efficacy of a mobile EMI (MIDY) for reducing risky drinking among young adults in Australia, and will add to the expanding literature on the use of mobile interventions for reducing risky alcohol consumption.Trial registrationAustralian New Zealand Clinical Trials Registration (ANZCTR): ACTRN12617001509358p; http://www.anzctr.org.au/ACTRN12617001509358p.aspx.International registered report identifier (irrid)DERR1-10.2196/14190.

Project description:RationaleChronic alcohol misuse can escalate into alcohol use disorder (AUD). The causal mechanisms through which recreational social drinking develops into compulsive uncontrolled alcohol misuse are multifaceted. For example, stress is an important risk factor that influences alcohol craving in both healthy and addicted individuals. In addition, those that are high in impulsivity/risk taking drink more and are at greater risk of developing addiction. At present, however, it is not possible accurately to predict those at risk of escalation in alcohol use, or of developing AUD.ObjectivesThe aim of this study was to investigate how underlying physiological and personality traits affect stress-induced craving for, and consumption of, alcohol, in a sample of social drinkers. The primary hypothesis was that impulsivity/risk-taking would modulate stress-induced alcohol craving and consumption.MethodsThirty-nine participants (22 male and 17 female; mean age = 23.92 years [SD = 4.90]) were randomly allocated to 'stress' and 'no-stress' groups; in the stress group, participants took part in the Trier Social Stress Test (TSST). Participants completed several questionnaires and computer tasks in order to assess prior alcohol use, impulsivity/risk-taking, stress-reactivity, craving and physiological biomarkers of stress. Finally, participants completed a voluntary drinking task, in which increasing numbers of presses on a computer keyboard were reinforced with 5-ml shots of 37% ABV vodka (plus mixer).ResultsParticipants exposed to the TSST showed an increase in craving following the stressor. Several factors predicted voluntary drinking, including risky decision making, slow HR recovery from stress, poor vagal tone during recovery from stress and greater stress reactivity. Surprisingly, we found no correlation between craving and consumption.ConclusionsOur data suggest that variation in physiological stress parameters and poor decision-making abilities increase risk of stress-induced alcohol consumption. This may provide a useful translational framework through which we can further study early predictive markers for the shift between controlled recreational drinking to uncontrolled alcohol misuse, including AUD.

Project description:BackgroundThe World Health Organization, governments, and communities agree that community action is likely to reduce risky alcohol consumption and harm. Despite this agreement, there is little rigorous evidence that community action is effective: of the six randomised trials of community action published to date, all were US-based and focused on young people (rather than the whole community), and their outcomes were limited to self-report or alcohol purchase attempts. The objective of this study was to conduct the first non-US randomised controlled trial (RCT) of community action to quantify the effectiveness of this approach in reducing risky alcohol consumption and harms measured using both self-report and routinely collected data.Methods and findingsWe conducted a cluster RCT comprising 20 communities in Australia that had populations of 5,000-20,000, were at least 100 km from an urban centre (population ? 100,000), and were not involved in another community alcohol project. Communities were pair-matched, and one member of each pair was randomly allocated to the experimental group. Thirteen interventions were implemented in the experimental communities from 2005 to 2009: community engagement; general practitioner training in alcohol screening and brief intervention (SBI); feedback to key stakeholders; media campaign; workplace policies/practices training; school-based intervention; general practitioner feedback on their prescribing of alcohol medications; community pharmacy-based SBI; web-based SBI; Aboriginal Community Controlled Health Services support for SBI; Good Sports program for sports clubs; identifying and targeting high-risk weekends; and hospital emergency department-based SBI. Primary outcomes based on routinely collected data were alcohol-related crime, traffic crashes, and hospital inpatient admissions. Routinely collected data for the entire study period (2001-2009) were obtained in 2010. Secondary outcomes based on pre- and post-intervention surveys (n?=?2,977 and 2,255, respectively) were the following: long-term risky drinking, short-term high-risk drinking, short-term risky drinking, weekly consumption, hazardous/harmful alcohol use, and experience of alcohol harm. At the 5% level of statistical significance, there was insufficient evidence to conclude that the interventions were effective in the experimental, relative to control, communities for alcohol-related crime, traffic crashes, and hospital inpatient admissions, and for rates of risky alcohol consumption and hazardous/harmful alcohol use. Although respondents in the experimental communities reported statistically significantly lower average weekly consumption (1.90 fewer standard drinks per week, 95% CI?=?-3.37 to -0.43, p?=?0.01) and less alcohol-related verbal abuse (odds ratio?=?0.58, 95% CI?=?0.35 to 0.96, p?=?0.04) post-intervention, the low survey response rates (40% and 24% for the pre- and post-intervention surveys, respectively) require conservative interpretation. The main limitations of this study are as follows: (1) that the study may have been under-powered to detect differences in routinely collected data outcomes as statistically significant, and (2) the low survey response rates.ConclusionsThis RCT provides little evidence that community action significantly reduces risky alcohol consumption and alcohol-related harms, other than potential reductions in self-reported average weekly consumption and experience of alcohol-related verbal abuse. Complementary legislative action may be required to more effectively reduce alcohol harms.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12607000123448.

Project description:Brief interventions via the internet have been shown to reduce university students' alcohol intake. This study tested two smartphone applications (apps) targeting drinking choices on party occasions, with the goal of reducing problematic alcohol intake among Swedish university students.Students were recruited via e-mails sent to student union members at two universities. Those who gave informed consent, had a smartphone, and showed risky alcohol consumption according to the Alcohol Use Disorders Identification Test (AUDIT) were randomized into three groups. Group 1 had access to the Swedish government alcohol monopoly's app, Promillekoll, offering real-time estimated blood alcohol concentration (eBAC) calculation; Group 2 had access to a web-based app, PartyPlanner, developed by the research group, offering real-time eBAC calculation with planning and follow-up functions; and Group 3 participants were controls. Follow-up was conducted at 7 weeks.Among 28574 students offered participation, 4823 agreed to join; 415 were excluded due to incomplete data, and 1932 fulfilled eligibility criteria for randomization. Attrition was 22.7-39.3 percent, higher among heavier drinkers and highest in Group 2. Self-reported app use was higher in Group 1 (74%) compared to Group 2 (41%). Per-protocol analyses revealed only one significant time-by-group interaction, where Group 1 participants increased the frequency of their drinking occasions compared to controls (p?=?0.001). Secondary analyses by gender showed a significant difference among men in Group 1 for frequency of drinking occasions per week (p?=?0.001), but not among women. Among all participants, 29 percent showed high-risk drinking, over the recommended weekly drinking levels of 9 (women) and 14 (men) standard glasses.Smartphone apps can make brief interventions available to large numbers of university students. The apps studied using eBAC calculation did not, however, seem to affect alcohol consumption among university students and one app may have led to a negative effect among men. Future research should: 1) explore ways to increase user retention, 2) include apps facilitating technical manipulation for evaluation of added components, 3) explore the effects of adapting app content to possible gender differences, and 4) offer additional interventions to high-risk users.clinicaltrials.gov: NCT01958398.

Project description:BACKGROUND:The literature shows that computer-delivered interventions with personalized normative feedback can reduce problem drinking for up to 6 months in the West. Meanwhile, no studies have been conducted to examine the effects of such interventions among Japanese problem drinkers. Possible moderators associated with effectiveness of the intervention need to be also explored. OBJECTIVE:The purpose of this study is to conduct a trial and examine the efficacy of a brief intervention with personal normative feedback and psychoeducation on several measures of alcohol consumption among Japanese problem drinkers. Additionally, this study will examine whether the level of alcohol use disorder and beliefs about the physical and psychological outcomes of drinking moderate the effect of the intervention on outcome measures. METHODS:This study will conduct a single-blind, 2-armed randomized controlled trial. Japanese adults with an Alcohol Use Disorder Identification Test score of 8 or higher will be enrolled in the trial. Participants allocated to the intervention group will receive the intervention immediately after the baseline measurements, and participants allocated to the waitlist group will receive the intervention at the end of the trial. Outcome measures include drinking quantity, drinking frequency, and alcohol-related consequences. Follow-up assessment will take place at 1 month, 2 months, and 6 months following the baseline measurement. The authors will not know the group allocation during trial. The authors will plan to collect a sample of 600 participants. Mixed-effect analyses of variance will be used to examine the main effects of condition, the main effects of time, and the interaction effects between condition and time on outcome variables. RESULTS:Enrollment for the trial began on January 6, 2018 and data are expected to be available by August 2018. CONCLUSIONS:This study will contribute to the literature by demonstrating the efficacy of Web-based screenings and brief interventions among Japanese problem drinkers and indicating several possible moderators between the intervention and outcomes. This type of Web-based brief intervention has the possibility of being implemented in Japanese schools and workplaces as a prevention tool. TRIAL REGISTRATION:UMIN Clinical Trials Registry R000034388; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000034388 (Archived by WebCite at http://www.webcitation.org/6xmOoTfTI). REGISTERED REPORT IDENTIFIER:RR1-10.2196/10650.

Dataset Information

Reducing Alcohol Consumption Among Risky Drinkers in the General Population of Sweden Using an Interactive Mobile Health Intervention: Protocol for a Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

Reducing Alcohol Consumption Among Risky Drinkers in the General Population of Sweden Using an Interactive Mobile Health Intervention: Protocol for a Randomized Controlled Trial.

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