Plain English Summary
Background and study aims
Alcohol-related problems represent a major public health challenge. People who are socially disadvantaged are at a substantially higher risk of developing alcohol-related diseases. The group who drink most alcohol and binge drink most frequently are young to middle aged disadvantaged men. There is a pressing need to change the culture of drinking among this group in order to prevent alcohol-related problems in later life. The main objective of this study is to determine whether a brief intervention delivered by mobile phone is an effective and cost-effective method of reducing the frequency of binge drinking by disadvantaged men. The impact of the intervention on other measures of drinking, such as total consumption, will also be assessed.
Who can participate?
Men aged 25-44 years living in areas of high deprivation will be recruited. Men will be included in the study if they have had two or more episodes of heavy drinking (more than eight units in a single session) in the preceding month.
What does the study involve?
Men will be recruited to the study by two methods: by letter of invitation from their own GP; and through a community outreach approach where men will be recruited from a variety of venues and work-places within the community. Participants will be randomly allocated to one of two groups. Both groups will receive a series of text messages delivered by mobile phone over a period of three months. Messages sent to the intervention group are designed to help the men to realise that they are at risk from their drinking and motivate them to change their drinking behaviour. The messages will help to increase their self-confidence to refuse drinks, encourage them to make a commitment to drinking less and support them to continue a pattern of reduced binge drinking. The control group will receive text messages on general health promotion. Participants will be followed up at three months and twelve months after the intervention has been delivered. The men will be asked to complete questionnaires by telephone interview.
What are the possible benefits and risks of participating?
The potential benefits are that participants will reduce their frequency of binge drinking. Participants in the intervention group will receive specific information about reducing alcohol consumption and strategies to for relapse prevention, so that they may achieve sustained behaviour change.No potential risks have been identified. The intervention is based on Alcohol Brief Interventions (ABI) to reduce alcohol consumption which have been extensively used in health care settings and have been shown to be effective in reducing consumption.
Where is the study run from?
The study is being run from the University of Dundee. Collaborators are also based at the Universities of Aberdeen, Glasgow Caledonian, Newcastle, St Andrews and Stirling in the UK and Melbourne, Australia. Participants will be recruited at four centres which cover major regions of Scotland, UK: Tayside, Glasgow, Forth Valley and Fife.
When is the study starting and how long is it expected to run for?
The study started in July 2013 and will run for three years and three months. Recruitment of participants will begin in March 2014 and will last for ten months.
Who is funding the study?
The study is funded by the NIHR Public Health Research Programme, UK.
Who is the main contact?
Professor Iain Crombie
i.k.crombie@dundee.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Iain K Crombie
ORCID ID
http://orcid.org/0000-0003-2623-3016
Contact details
University of Dundee
Population Health Sciences
Medical Reseach Institute
The Mackenzie Building
Kirsty Semple Way
Dundee
DD2 4BF
United Kingdom
+44 (0)1382 383745
i.k.crombie@dundee.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PHR 11/3050/30; 1.0
Study information
Scientific title
Reducing binge drinking among disadvantaged men through an intervention delivered by mobile phone: a multi-centre randomised controlled trial
Acronym
TRAM
Study hypothesis
A brief alcohol intervention delivered by mobile phone will reduce binge drinking among disadvantaged young to middle-aged men.
Ethics approval
East of Scotland Research Ethics Service (EoSRES) REC 1, 18/06/2013, ref: 13/ES0058
Study design
Randomised 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 to request a patient information sheet
Condition
Alcohol-related problems
Intervention
Current interventions as of 26/08/2014:
Participants are randomised to two groups. Randomisation will be carried out using the secure remote web-based system provided by the Tayside Clinical Trials Unit. Randomisation will be stratified by participating centre and the recruitment method and restricted using block sizes of randomly varying lengths.
1. Intervention group: A series of interactive text messages will be delivered over a three month period. The intervention will be delivered in four stages:
Stage 1 will welcome participants, establish empathy and raise awareness about alcohol harms.
Stage 2 consists of a series of pre-intentional texts which will encourage intention to change.
Stage 3 is designed to transform intentions into action.
Stage 4 addresses relapse prevention to achieve sustained behaviour change.
2. The control group will also receive a series of interactive text messages for the twelve weeks of the intervention. The texts will be designed to be behaviourally neutral, by avoiding the behaviour change strategies employed in the active intervention. The messages will consist of jokes and interesting or unusual facts about health, unrelated to alcohol. They will be designed to maintain interest in the study to ensure that the control group complete the outcome assessments.
Previous interventions:
Participants are randomised to two groups. Randomisation will be carried out using the secure remote web-based system provided by the Tayside Clinical Trials Unit. Randomisation will be stratified by participating centre and the recruitment method and restricted using block sizes of randomly varying lengths.
1. Intervention group: A series of interactive text messages and images will be delivered over a three month period. The intervention will be delivered in four stages:
Stage 1 will welcome participants, establish empathy and raise awareness about alcohol harms.
Stage 2 consists of a series of pre-intentional texts which will encourage intention to change.
Stage 3 is designed to transform intentions into action.
Stage 4 addresses relapse prevention to achieve sustained behaviour change.
2. The control group will receive one text message per week for the twelve weeks of the intervention. The texts will be designed to be behaviourally neutral, by avoiding the behaviour change strategies employed in the active intervention. The messages will consist of jokes and interesting or unusual facts about health, unrelated to alcohol. They will be designed to maintain interest in the study to ensure that the control group complete the outcome assessments.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The proportion of men consuming more than 8 units of alcohol on at least three occasions in the previous 30 days, one year after the intervention has been delivered
Secondary outcome measures
1. The proportion of men consuming more than 8 units of alcohol on at least three occasions in the previous 30 days, three months after the intervention has been delivered.
2. The proportion of men consuming more than 16 units in a single session in the previous 30 days, three months after the intervention has been delivered.
3. The proportion of men consuming more than 16 units in a single session in the previous 30 days, twelve months after the intervention has been delivered.
4. The proportion of men drinking hazardously [measured by the Fast Alcohol Screening Test (FAST)], twelve months after the intervention has been delivered.
5. Total alcohol consumption (units in the previous 30 days), twelve months after the intervention has been delivered.
Overall trial start date
01/07/2013
Overall trial end date
30/09/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Men aged 25 - 44 years living in socially disadvantaged communities who have consumed more than eight units of alcohol in a single drinking session at least twice in the preceding four weeks.
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
798
Participant exclusion criteria
1. Men who are currently attending an Alcohol Problem Service
2. Men who cannot communicate in English (verbally and by text message)
3. Men who will not be contactable by mobile phone for any part of the intervention period.
Recruitment start date
01/03/2014
Recruitment end date
01/01/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Dundee
Dundee
DD2 4BF
United Kingdom
Sponsor information
Organisation
University of Dundee and Tayside Health Board (UK)
Sponsor details
Tayside Medical Science Centre (TASC)
Ninewells Hospital & Medical School
Research & Development Office
Residency Block
Level 3
George Pirie Way
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 383890
c.forde@dundee.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Public Health Research Programme
Alternative name(s)
NIHR Public Health Research Programme, PHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The full results will be published in Public Health Research. The anticipated publication date is January 2018. Further papers in high-impact peer reviewed journals are planned to be published in late 2017 and early 2018.
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available because the NHS Research Ethics approval for the study was on the basis of only the research team and individuals from regulatory authorities having access to the raw data.
Intention to publish date
01/01/2018
Participant level data
Not expected to be available
Basic results (scientific)
See additional file ISRCTN07695192_BasicResults_22Sep17
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25526870
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28702758
2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29927564
Publication citations
Additional files
- ISRCTN07695192_BasicResults_22Sep17.pdf Uploaded 23/11/2017