Plain English Summary
Background and study aims
Binge drinking is drinking a significant number of alcoholic beverages with the intention of having enough to become intoxicated, or drunk, over a short period of time. It can lead to antisocial behavior and violence, and also to a number of health problems; this not only affects the individual, it also results in increased costs to healthcare services. There have been studies involving the use of tailored feedback generated by a computer programme that have been successful in reducing binge drinking among university and college students in the United States. It works by providing the student with information on their own drinking habits compared with what is considered the social norm in order to change their perception of what they would consider normal drinking behavior. It is hoped that a similar approach will reduce alcohol use in young people with a lower level of education as well, but little research has been done on this as yet. It is thought, however, that shorter and more frequent feedback messages may be needed for individuals with a poorer educational background and that they might benefit from getting support for a longer time period in order to change their drinking behavior long-term. Text messaging (SMS) is a proactive and low cost way of sending short messages at any time and place and it is a way of delivering tailored information to young people at times when they are most likely to drink alcohol. The main aim of this study is to assess how successful a combined web and test messaging based programme (the intervention) is reducing problem drinking in young people with different educational backgrounds.
Who can participate?
Young people over the age of 15 who have a mobile phone.
What does the study involve?
Participants are randomly allocated to one of two groups. Group 1 receive the intervention and have their alcohol use monitored. Group 2 just have their alcohol use monitored. Group 1 get a individually tailored web-based feedback on the number of drinks they have each week compared to a reference group that represents what would be the social norm for their age and gender. The number of times they have indulged in risky drinking (5 drinks on any one occasion for males, 4 times for females) is recorded. They are told how much they spend on alcohol and how many calories their drinks contain. They also get individually tailored mobile phone messages over a 3 month period that encourage the participant to keep their drinking to a safe limit and resist alcohol altogether. The drinking habits of the participants are then followed up 6 months later.
What are the possible benefits and risks of participating?
We expect that the intervention will reduce binge drinking. There are considered to be no risks.
Where is the study run from?
Swiss Research Institute for Public Health and Addiction (Switzerland)
When is the study starting and how long is it expected to run for?
September 2014 to August 2016
Who is funding the study?
Swiss National Science Foundation (Switzerland)
Who is the main contact?
Dr. Severin Haug
severin.haug@isgf.uzh.ch
Trial website
Contact information
Type
Scientific
Primary contact
Dr Severin Haug
ORCID ID
Contact details
Konradstrasse 32
Zurich
8031
Switzerland
+41 (0) 44 448 11 74
severin.haug@isgf.uzh.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
100014_149209/1
Study information
Scientific title
Efficacy of a web and text messaging based intervention to reduce problem drinking in young people: a cluster-randomized controlled trial
Acronym
Study hypothesis
The main objective of the planned study is to test the efficacy of a combined web and text messaging based intervention to reduce problem drinking in young people. Our main hypothesis is that the intervention will be more effective than assessment only in reducing indicators of problem drinking assessed at six month follow-up.
Ethics approval
Ethics committee of the Philosophical Faculty of the University of Zurich, Switzerland, 24/06/2014
Study design
Single center, two-arm, cluster randomized, single blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet.
Condition
Alcohol consumption, Problem drinking
Intervention
Intervention Group:
Web-based feedback including individually tailored graphical and textual information concerning:
1. The number of drinks consumed per week in relation to the age and gender-specific reference group
2. Financial costs of drinking
3. Calories consumed with alcoholic drinks
4. Number of RSOD occasions in relation to the age and gender-specific reference group
The participants in the intervention group will receive a single web-based feedback immediately after the baseline assessment.
Individually tailored mobile phone text messages to stimulate
1. Positive outcome expectations to drink within low-risk limits
2. Self-efficacy to resist alcohol
3. Planning processes to translate intentions to resist alcohol into action
Participants will receive up to two weekly text messages over a time period of 3 months.
Control Group: No intervention
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Frequency of risky single occasion drinking (RSOD) occasions in the last 30 days (How often did you have (male: 5 female: 4) or more drinks on one occasion in the last 30 days?).
Secondary outcome measures
1. Quantity of alcohol consumption, assessed by a 7 day drinking calendar for which participants are asked to think about a typical week in the past month and, for each day, to record the number of standard drinks they typically consume on that day.
2. Peak blood alcohol concentration assessed by asking participants to report the number of standard drinks consumed and the duration of their heaviest drinking episode in the previous 30 days. This information will be used along with the sex and weight to calculate an estimated peak blood alcohol concentration based on the Widmark Formula.
3. Normative misperceptions of alcohol consumption.
Overall trial start date
01/09/2014
Overall trial end date
31/08/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age > 15 years
2. Possession of a mobile phone
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
n=467 per study group (intervention and control) resulting in a total of n=934 study participants
Participant exclusion criteria
None
Recruitment start date
01/09/2014
Recruitment end date
31/08/2016
Locations
Countries of recruitment
Switzerland
Trial participating centre
Konradstrasse 32
Zurich
8031
Switzerland
Sponsor information
Organisation
Swiss Research Institute for Public Health and Addiction (Switzerland)
Sponsor details
c/o Severin Haug
Konradstrasse 32
Zurich
8031
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Funding for this study is provided by the Swiss National Science Foundation (No. 100014_149209/1) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25099872
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/27606700
Publication citations
-
Protocol
Haug S, Kowatsch T, Castro RP, Filler A, Schaub MP, Efficacy of a web- and text messaging-based intervention to reduce problem drinking in young people: study protocol of a cluster-randomised controlled trial., BMC Public Health, 2014, 14, 809, doi: 10.1186/1471-2458-14-809.