Title: Modifying Alcohol Consumption to Reduce Obesity (MACRO): developing and feasibility testing of a complex community-based intervention for men
Funder: Chief Scientist Office (Scotland)

Abstract: Design: This community based study will test the feasibility and acceptability of a novel alcohol intervention. Phase 1 will develop the recruitment strategy and the alcohol intervention. It will comprise 6 focus groups with obese men and in-depth interviews with 6 key stakeholders. Phase 2 will recruit and randomise 60 men (35-64 years). The intervention group will receive a novel extended alcohol intervention incorporating behaviour change theory and techniques. The comparator group will receive a conventional brief alcohol intervention. A key feature of the study is that the intervention will be developed to be delivered by a trained lay person. A major output is a manual of all study methods.Setting: Community dwelling individuals will be recruited. The intervention will be delivered in the community at participants’ preferred venues. Target population: Obese men who drink in excess of the recommended guidelines.Recruitment: In Phase 1 obese men will be purposively sampled from community groups and workplaces. In addition stakeholders (e.g. factory manager community centre manager voluntary sector representative) will be recruited from workplaces.In Phase 2 two complementary recruitment strategies will be assessed to ensure recruitment of this group of hard to reach men. The first is the commonly used method of recruiting through primary care records. The second is a community outreach approach time-space sampling that is successful with hard to reach groups. This approach will be supported by initial fieldwork.Inclusion criteria: Men aged 35-64 years who have consumed more than 21 units per week during the previous 4 weeks and who are obese (BMI over 30).Exclusion criteria: Men currently using Alcohol Problem Services or Weight Management Services.Health technology being assessed:A low cost gender-specific interactive intervention will be designed to reach large numbers of men at risk of obesity and alcohol related problems The intervention is based on reviews of successful behaviour change strategies taxonomies of behaviour change techniques and lessons learned from a recent NIHR funded feasibility study of a brief alcohol intervention. The intervention will be structured around the Health Action Process Approach (HAPA) which is the most comprehensive of current models allowing integration of a range of evidence based behaviour change techniques. It will be delivered in 3 parts. Part 1: A face to face session will focus on weight loss through reduced alcohol consumption. It will last around 20 minutes and will include feedback on the person’s alcohol use and weight. Motivational interviewing techniques will be used 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 emphasise the benefits of weight loss including body image and sexual potency. Men will be encouraged to analyse high-risk situations for drinking and develop coping strategies as part of a personal plan to reduce consumption. The face to face session will be delivered by lay trainers who will be selected from the same community as the target group. The training will be developed from the Department of Health trainers’ manual. It will be delivered through small group training with an emphasis on practising the skills delivered. Training will be augmented by practice with volunteers from the target group.Part 2: Men will complete a volitional help sheet a tool designed to enable participants to avoid heavy alcohol consumption through forward planning.Part 3: A series of text messages will be delivered by mobile phone over two months. Messages will reinforce and extend the behaviour change strategy. Texts will increase self-efficacy for maintenance of reduced drinking and men will be asked to develop strategies for relapse prevention. This extended interactive phase will maintain engagement with the behaviour change strategy address relapse prevention and aid sustained behaviour change.Measurement of costs and outcomes: Outcomes will be measured 3 months after delivery of the intervention. Primary outcomes for the feasibility study are: recruitment and retention; acceptability of the intervention; and engagement with components of the behaviour change strategy. Secondary outcomes are: the impact of the study on the perceived benefits of moderated drinking; intention to reduce alcohol consumption; and self-efficacy to reduce drinking and lose weight. The two primary outcome measures for a full RCT reported weekly alcohol consumption and weight loss will be measured. Two validated economic appraisal questionnaires (EQ-5D and CSRI) will be included to inform the design of a definitive economic appraisal.Process measures: Delivery of the text messages will be recorded by the computer system delivering the intervention. Some texts will ask questions the responses to which will be evaluated to monitor engagement with components of the behaviour change strategy. The follow up interview will also be used to assess the acceptability and impact of the intervention by asking detailed questions about all parts of the study.Sample size: As this feasibility study will not measure effectiveness a formal sample size calculation is not required. For Phase 1 six focus groups will be sufficient to elicit the views of men and guide the development of the intervention. Six in-depth interviews with key stakeholders will identify opportunities for recruitment. For Phase 2 60 subjects will be sufficient to test the feasibility of all aspects of the study.Project timetable and recruitment:Phase 1 months 1-10: Conduct focus groups and in-depth interviews; analyse data; develop recruitment strategy design intervention; recruit GP practices and community venues for recruiting participants; recruit and train lay people to deliver the intervention; construct framework for the study manual; pilot all parts of Phase 2Phase 2 months 11-15: Recruit and randomise 60 men (6 per week); conduct baseline assessment; deliver the intervention; develop and pilot follow-up questionnaires Phase 2 months 16-21: Follow up interviews; analyse data; finalise the study manual; write reports; disseminate findings


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: STROKE;CANCER AND NEOPLASMS;METABOLIC AND ENDOCRINE;CARDIOVASCULAR;ORAL AND GASTROINTESTINAL