Plain English Summary
Background and study aims
Obesity (being very overweight) and harm caused by drinking too much alcohol are major public health problems. People who are obese and also drink too much alcohol are at a very high risk of developing a number of health problems, particularly liver disease. Many obese men want to lose weight, but are reluctant to try the conventional ways to do so. This study will develop a treatment (or intervention) designed especially for men that aims to reduce the amount of alcohol they drink through the motivation of weight loss. It will offer help and support in order to change the behaviour of those taking part. A key feature of the intervention will be an emphasis on the benefits of losing weight. It is designed to reach large numbers of men at risk of obesity and alcohol-related problems and targets those who might not be identified through the health care system. We want to find out whether a full clinical trial that tests that the intervention works is feasible. If so, the intervention will subsequently be tested in a full randomised controlled trial.
Who can participate?
Men aged 35-64 years who regularly drink over 21 units of alcohol per week and are obese (BMI>30).
What does the study involve?
Men are recruited to the study by two methods: by letter of invitation from their own GP and through a community outreach approach where men are recruited from a variety of venues and work-places within the community. Participants are randomly allocated to either a intervention or control group. Those in the intervention group have a 20-30 minute face to face session with a trained coordinator which focuses on how they may lose weight though cutting down on their alcohol intake. It looks at, among other things, strategies for coping in situations which may encourage heavy drinking, and a personal plan to reduce how much alcohol they drink. Motivational text messages are then sent to each participant over the next two months. Those in the control group are given a conventional 10-20 minute face to face session on alcohol abuse. Participants in both groups are followed up five months later to assess their progress.
What are the possible benefits and risks of participating?
The potential benefits are that participants will be encouraged to reduce the amount of alcohol they drink.
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, Newcastle and Stirling in the UK.
When is the study starting and how long is it expected to run for?
May 2014 to January 2016
Who is funding the study?
NIHR Health Technology Assessment (NIHR HTA), UK.
Who is the main contact?
Professor Iain Crombie
Prof Iain K Crombie
University of Dundee
Population Health Sciences
Medical Research Institute
The Mackenzie Building
Kirsty Semple Way
+44 (0) 1382 383745
Modifying Alcohol Consumption to Reduce Obesity (MACRO): developing and feasibility testing of a complex community-based intervention for men
A tailored alcohol intervention will reduce alcohol consumption among obese men through the motivation of weight loss
East of Scotland Research Ethics Service (EoSRES) REC 2, 28/05/2014, ref. 14/ES/0050
Feasibility study with a randomised controlled component
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Obese men who regularly drink alcohol
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.
The intervention will be delivered in two stages: an initial face to face session and a series of text messages. The face to face session will focus on weight loss through reduced alcohol consumption. It will include: feedback on the persons alcohol use and weight and will use motivational enhancement to clarify how reducing alcohol consumption can assist with weight loss and can reduce the harmful synergistic effects of obesity and heavy alcohol consumption. It will encourage the analysis of high risk situations for drinking; assist with planning coping strategies; and introduce the development of a personal plan to reduce consumption. This session will be delivered by trained lay coordinators and will last approximately 20 - 30minutes. Sessions will be audio recorded and will be scrutinised by an independent researcher to assess fidelity of delivery of the intervention. After the face to face session a series of messages and images will be delivered by mobile phone over two months. These messages will reinforce the content of the face to face intervention and extend the behaviour change strategy.
The comparator group will receive a conventional brief alcohol intervention which will be delivered in one face to face session by a trained lay person. The session will last approximately 10 20 minutes.
Primary outcome measures
Primary outcomes for assessing the success of the feasibility study are:
1. Recruitment and retention of participants
2. Acceptability of the intervention
3. Engagement with components of the behaviour change strategy
These measure test whether the feasibility study was successfully conducted. Each will be based on data collected at several time points throughout the study, as they are concerned with study conduct.
Secondary outcome measures
1. The impact of the study on the perceived benefits of moderated drinking
2. Intention to reduce alcohol consumption
3. Self-efficacy in ability to reduce drinking and lose weight
The two primary outcome measures for a full RCT of the intervention will also be measured, although there will be insufficient numbers of participants in the feasibility study to detect treatment effects:
1. Reported weekly alcohol consumption
2. Weight loss
These will be measured at 5 months from randomisation
Overall trial start date
Overall trial end date
Participant inclusion criteria
Men aged 35-64 years; who regularly consume >21 units of alcohol per week; and are obese (BMI>30).
Target number of participants
Participant exclusion criteria
1. Men who are currently attending an Alcohol Problem Service
2. Men who are currently attending a weight loss programme
3. Men who cannot communicate in English (verbally and by text message)
4. Men who cannot be contacted by mobile phone for any part of the intervention period
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University of Dundee
University of Dundee and Tayside Health Board (UK)
Tayside Medical Science Centre (TASC)
Ninewells Hospital & Medical School
Research & Development Office
George Pirie Way
+44 (0)1382 383890
National Institute for Health Research Health Technology Assessment (NIHR HTA) (UK) Reference: 12/139/12
Funding Body Type
Funding Body Subtype
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