None listed
Conditions
Brief summary
Blood vessel disease is linked with risk of dementia, cardiovascular disease and falls. A large clinical trial will determine if a novel, low-cost, behaviour change program (knowledge of level of blood vessel disease, its links with risk of dementia, cardiovascular disease and falls, and the benefits of and how to follow a Mediterranean diet) will motivate an individual to make healthy lifestyle changes and will improve measures of risk for dementia, cardiovascular disease and falls. The study hypothesis is that adherence to the MedDiet will be improved after provision of the behaviour change program.
Interventions
The aim of this clinical trial is to evaluate a behaviour change program that provides (i) information on level of advanced structural vascular disease (AAC, the stimulus for change), (ii) its relationship with dementia, cardiovascular disease (CVD), and falls (the possible consequences), and (iii) the benefits of and guidelines to follow a Mediterranean diet (MedDiet), a dietary pattern linked to improved cognitive, cardiovascular, and musculoskeletal health outcomes. The program incorporates gold-standard behavioural change techniques. Behaviour Change Program Baseline. Participants randomised into the “behaviour change program” will have their AAC determined from a lateral lumbar spine X-ray taken during a DXA scan. This will be performed during their baseline assessment period. Two weeks post the DXA scan, participants will individually meet with a Study Nurse who will provide a 30-minute consultation guided by motivational interviewing principles. These visits, using videos and handouts are based on those that we have developed and tested previously and have been created specifically for this study: Video: An explanation of abdominal aortic calcification (AAC) and its link with dementia, CVD, falls and fracture risk. The video will encourage diet and physical activity changes to reduce the risk of these conditions. Information on MedDiet, its importance and recommendations for goals focusing on the major components of the MedDiet to be achieved and maintained: Per day: i) 1-3 tablespoons extra virgin olive oil [substituting for other forms of fats such as butter and margarine], ii) Greater than or equal to 5 servings vegetables (including one serve of green leafy vegetables and one serve of cruciferous vegetables), iii) Greater than or equal to 2 servings fruit, iv) 3-6 servings grain foods (focusing on wholegrain cereals), v) up to 2 serves of plain yoghurt and cheese. Per week: i) Greater than or equal to 5 servings nuts, ii) Greater than or equal to 2 servings fish, and iii) Greater than or equal to 3 servings legumes. AAC results: participants will then be provided with their AAC results. This will include a graphic image showing how much calcification is present. The Study Nurse will review and discuss the results with participants and answer any questions to enhance understanding of the results. Hard copy booklet: participants will be provided with a hard copy MedDiet resource pack(created specifically for this study) providing written information describing the MedDiet including information on the important healthy components of the MedDiet, other components of the MedDiet, serving sizes, the recommended number of servings, tips for eating out, a checklist for self-monitoring of MedDiet adherence, a recipe book and physical activity guidelines. Website: participants will be provided with access to a study website which will contain further resources such as recipes, podcasts, cooking demonstrations, and exercise videos. 3 months post-baseline. Participants will have a 15-minute face-to-face consultation with the Study Nurse to provide feedback and reinforce the goals of the study. Throughout the 12 month period, participants in the Behaviour Change Program will have access to the study website and their adherence to the MedDiet will be assessed monthly using a validated Mediterranean diet and culinary index (MediCul) questionnaire.
Sponsors
Study design
Eligibility
Inclusion criteria
Community dwelling postmenopausal older women
Exclusion criteria
Individuals volunteering to participate in the study will be excluded according to the following criteria: (i) a confirmed dementia diagnosis, (ii) history of vascular disease or chest pain suggestive of angina pectoris, (iii) significant comorbidities such as end stage renal disease (glomerular filtration rate <30ml/min or dialysis), cancer requiring active surveillance or treatment, history of heart failure, (iv) BMI greater than or equal to 37 kg/m2 or BMI <18 kg/m2 or body weight >125 kg; (v) type 1 diabetes; (vi) systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg; (vii) use of anticoagulant therapy (Warfarin); (viii) diagnosis of osteoporosis within the previous 6-months or evidence of osteoporosis at the bone density testing visit; (ix) those unable or unwilling to follow the study protocol, (x) those without access or inability to use a computer/smart device; (xi) currently meeting the MedDiet recommendations for more than 4 of the important healthy components of a MedDiet: olive oil (1-3 Tbsp/day), vegetables (greater than or equal to 5 serves/day), fruit (greater than or equal to 2 serves/day), whole grain foods (3-6 serves/day), nuts (greater than or equal to 5 serves/week), fish (greater than or equal to 2 serves/week), legumes (greater than or equal to 3 serves/week), and discretionary foods (less than or equal to 3 serves/day).