Impact of knowledge of vascular disease on Modification Of Diet, Exercise and Lifestyle: The MODEL study

This study will be both interventional and observational. Participants will be recruited to an 12-week randomized controlled trial. All participants will then be followed out to 2 years in an observational study. 1. The randomised controlled trial A 12-week randomized controlled design trial in men and women will be performed. All participants will have a lateral spine image captured using dual-energy x-ray absorptiometry (DXA), and the presence and severity of abdominal aortic calcification (AAC) assessed from the lateral spine image. It is anticipated that more than half of all men and women (60 to 80 years old) recruited to the study will have evidence of calcification in the abdominal aorta: this indicates presence of advanced vascular disease. Therefore, an AAC assessment provides participants with knowledge of presence and severity of advanced vascular disease. Participants will be randomised (1:1) to either have knowledge of their AAC provided to them at baseline, approximately 2 weeks after their baseline assessments (intervention group) or have knowledge of their AAC provided at the end (week 12) of the RCT (the wait-listed control group). All participants will receive standardised diet and lifestyle advice provided in a booklet approximately 2 weeks after their baseline assessments, and a video (via email). At baseline the intervention group will also be given access to a video that explains their AAC result. The same video will be provided to the wait-listed control group at the at the end (week 12) of the RCT together with their AAC scan result. All clinical assessments will be performed at baseline and 12 weeks. When participants receive their AAC result, this will also be sent to the participant’s GP together with a GP’s information sheet describing AAC. Participants will be encouraged to discuss their results with their GP. In addition to the email with the video links and booklet, participants will receive a call from a study investigator (on the same day wherever possible), who will briefly explain the AAC scan results (invervention group at baseline and wait-listed control group at 12 weeks) and reinforce the lifestyle advice provided in the booklet and video. Both the booklet and video have been designed and produced specifically for this study. The day and time of the phone call will be booked at the time of the participant’s baseline visit. During the phone call the study investigator will reinforce three goals to be achieved within 12 weeks: i) The first of these will be to increase fresh fruit intake and increase vegetable intake; ii) The second goal will be to improve other aspects of their diet including reducing the intake of salt, alcohol, processed meats, and increasing the intake of whole grains, seeds, nuts and healthy oils such as olive oil; and (iii) The third goal will be to increase physical activity and reduce inactivity (sitting time). This design of the trial will allow assessment of the effect of providing knowledge of advanced structural vascular disease on primary and secondary outcomes. The primary aim of the randomised controlled trial is to determine if providing knowledge of advanced structural vascular disease can lead to a short-term (12 weeks) increase in fruit and vegetable intake, compared to control (no knowledge of AAC). The impact on a variety of other dietary and lifestyle factors and measures related to health status will also be assessed. 2. The observational study (2 years) The observational study will follow all participants recruited to the 12 week randomised controlled trial out to 2 years. All participants will be provided with the results of their assessment of AAC by 12 weeks (end of the randomised controlled trial phase of the study). All participants will also have received counselling and information on how to improve their diet and lifestyle, including how to increase fruit and vegetable intake, improve other aspects of diet and increase physical activity. This advice will provided at baseline and re-enforced again at 12 weeks. The primary aim of the observational study is to investigate whether the knowledge of the presence of advanced vascular disease is associated with higher fruit and vegetable intake. We will also assess other dietary and lifestyle factors and measures related to health status.