Condition category
Mental and Behavioural Disorders
Date applied
24/06/2014
Date assigned
10/07/2014
Last edited
08/08/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.isgf.ch

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

Publication citations

  1. 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.

Additional files

Editorial Notes