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Background and study aims A Mediterranean-style diet has been shown to reduce the risk of developing heart disease, stroke and diabetes. This study aims to determine whether people will change their diet to make it more like a Mediterranean diet, and to determine whether different ways of supporting people will make people adopt the Mediterranean diet. Who can participate? Aged over 40 years, overweight and at increased risk of heart disease (i.e. with high blood pressure and/or cholesterol levels) but with no previous medical history of heart disease, stroke or diabetes, who do not currently follow a Mediterranean diet and are willing to make changes to their current diet towards a Mediterranean-style diet. What does the study involve? Participants will be randomly allocated to one of three groups: First group: brief written advice about the Mediterranean diet. This involves one 30-minute visit with the researcher at the beginning of the study. If you are in this group, you will be offered a further appointment for personalised dietary advice at the end of the study. Second group: intensive advice to adopt the Mediterranean diet. If you are in this group you will receive an appointment with the study dietitian for individual dietary advice. This visit will last for up to 90 minutes. You will then be asked to attend a group education session once every three months over the 12-month study period (i.e., five group sessions in total), run by the dietitian. Each group session is expected to last no longer than 2 hours and will be scheduled at a convenient time. In addition, we will deliver some key Mediterranean foods to your home throughout the 12-month study period. Third group: peer support to encourage adoption of the Mediterranean diet. If you are in this group you will attend 11 group support sessions over 12 months with up to six other people who are similar to you, along with two dedicated peer supporters. Each group session is expected to last no longer than 2 hours and will be held in a convenient location at a flexible time. The study will last one year. At the beginning of the study and after 3 months, 6 months and 12 months (therefore four times over the study period) you will be asked to meet with the researcher to provide a blood and urine sample, complete study measurements (including weight measurements and an oral glucose tolerance test to see how well your body deals with sugar) and complete study questionnaires. What are the possible benefits and risks of participating? This study is designed to determine whether different methods of giving dietary advice have an impact on how much change people will make to their diet. A further study is planned to determine whether that dietary change (i.e., towards a Mediterranean diet) could reduce the risk of diabetes or heart disease, and these studies together could therefore have important public health benefits. There is a small risk of developing bruising after the blood sampling, but a fully trained phlebotomist will take the blood samples to ensure that any discomfort is kept to a minimum. Where is the study run from? The study is recruiting people in Northern Ireland and all study assessments will take place in the Centre for Public Health at Queen's University Belfast. When is the study starting and how long is it expected to run for? The study started in January 2014 and will run until April 2016. Who is funding the study? The Medical Research Council, UK. Who is the main contact? Professor Jayne Woodside [email protected]

Inclusion criteria

• Cardiovascular disease and type 2 diabetes disease prevention

Links

• ictrp
• isrctn