Alcohol and disadvantaged men: developing a brief intervention for delivery by mobile phone

ISRCTN	ISRCTN10515845
DOI	https://doi.org/10.1186/ISRCTN10515845
Secondary identifying numbers	1.1

Submission date: 17/12/2009
Registration date: 17/02/2010
Last edited: 08/10/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Iain K Crombie
Scientific

Department of Public Health
Division of Clinical & Population Sciences & Education
Mackenzie Building
Kirsty Semple Way
Dundee
DD2 4BF
United Kingdom

Phone	+44 (0)1382 420 102
Email	abc@email.com

Study information

Study design	Feasibility study with a randomised controlled component
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Community
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Reducing alcohol-related harm in disadvantaged men: development and feasibility assessment of a brief intervention delivered by mobile phone
Study objectives	Can a brief intervention delivered by mobile reduce heavy drinking among disadvantaged young to middle aged men?
Ethics approval(s)	Tayside Committee on Medical Research Ethics A, 13/11/2009, ref: 09/S1401/78
Health condition(s) or problem(s) studied	Alcohol-related problems
Intervention	A series of 28 interactive text messages and images to be delivered over a 4-week period to participants in both arms of the study. The intervention group will receive messages to address four areas: 1. Increasing awareness of and perceived risk of experiencing alcohol-related harm 2. Modifying the balance between perceived benefits and harms of alcohol 3. Addressing misperceptions about alcohol consumption by peers 4. Increasing the ability to refuse drinks The comparator group will receive the same number of text messages and images. These will cover the general health promotion messages from current government public health policy. These include diet, physical activity, smoking and mental wellbeing. The total duration of the intervention is 28 days. Participants will be followed up for 3 months.
Intervention type	Behavioural
Primary outcome measure	The change in frequency of heavy drinking (consumption of 8 or more units in a single session), measured at 3 months
Secondary outcome measures	Measured at 3 months: 1. The extent to which the intervention has influenced perceptions of harms 2. The benefits of moderated drinking 3. Intentions for future drinking
Overall study start date	01/03/2010
Completion date	30/11/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	Phase 1: 50 focus group participants; Phase 2: 60 men; Phase 3: 20 men recruited from Phase 2
Key inclusion criteria	1. Men aged 25 - 44 years 2. Living in deprived urban communities 3. Have consumed 8 or more units of alcohol in a single drinking session at least twice in the preceding 4 weeks
Key exclusion criteria	Cannot communicate (verbally and by text message) in English
Date of first enrolment	01/03/2010
Date of final enrolment	30/11/2011

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Department of Public Health

Dundee
DD2 4BF
United Kingdom

Sponsor information

University of Dundee (UK)
University/education

Research and Innovation Services
11 Perth Road
Dundee
DD1 4HN
Scotland
United Kingdom

Phone	+44 (0)1382 344 644
Email	j.houston@dundee.ac.uk
Website	http://www.dundee.ac.uk/
"ROR"	https://ror.org/03h2bxq36

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Public Health Research Programme (ref: 09/3001/09)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2017	08/10/2020	Yes	No

Editorial Notes

08/10/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.