Condition category
Mental and Behavioural Disorders
Date applied
17/12/2009
Date assigned
17/02/2010
Last edited
05/08/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Iain K Crombie

ORCID ID

Contact details

Department of Public Health
Division of Clinical & Population Sciences & Education
Mackenzie Building
Kirsty Semple Way
Dundee
DD2 4BF
United Kingdom
+44 (0)1382 420 102

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.1

Study information

Scientific title

Reducing alcohol-related harm in disadvantaged men: development and feasibility assessment of a brief intervention delivered by mobile phone

Acronym

Study hypothesis

Can a brief intervention delivered by mobile reduce heavy drinking among disadvantaged young to middle aged men?

Ethics approval

Tayside Committee on Medical Research Ethics A, 13/11/2009, ref: 09/S1401/78

Study design

Feasibility study with a randomised controlled component

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 patient information sheet

Condition

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/03/2010

Overall trial end date

30/11/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Phase 1: 50 focus group participants; Phase 2: 60 men; Phase 3: 20 men recruited from Phase 2

Participant exclusion criteria

Cannot communicate (verbally and by text message) in English

Recruitment start date

01/03/2010

Recruitment end date

30/11/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Public Health
Dundee
DD2 4BF
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

Research and Innovation Services
11 Perth Road
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 344 644
j.houston@dundee.ac.uk

Sponsor type

University/education

Website

http://www.dundee.ac.uk/

Funders

Funder type

Government

Funder name

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

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

Publication citations

Additional files

Editorial Notes