None listed
Conditions
Brief summary
There is convincing evidence that a healthy balanced diet protects against future cardiovascular disease and associated comorbidities. However changing habitual dietary patterns towards a healthier choices can be hard for many, especially without additional support. We have looked at the usual care provided in New Zealand following an acute coronary event. This includes pharmacological interventions and lifestyle advice, such as adoption of a healthy diet. We are interested to see if the provision of certain foods increases adherence to a healthy diet, and improves cardiometabolic risk factors beyond the benefits obtained from usual care. We will be testing two active interventions and comparing them against the results achieved through usual care. One intervention is the provision of high fibre carbohydrates such as tinned legumes, wholegrain foods, vegetables, and fruit. The other intervention is the provision of foods high in healthy fats (vegetable oil, margarine, tinned oily fish, nuts, seeds, and avocado). Interventions will be over 12 weeks, with each participant randomised to one of the three trial arms for that time. We will assess cardiometabolic risk factors at the start and at the end of each intervention. Our hypothesis is that usual care and the provision of foods inline with a healthy diet following an acute cardiovascular event improves cardiometabolic risk factors to a greater extent than what is obtained by current usual care alone.
Interventions
Three arm trial with interventions of twelve weeks duration. The control arm is the provision of usual care following a coronary event, including both pharmacological intervention and lifestyle advice (usual care arm). The usual care for all trial participants will be delivered by the cardiovascular outpatient clinics available to all people following an acute coronary event in New Zealand.
One active intervention is the provision of usual care and a weekly delivery of high fibre carbohydrate f
Three arm trial with interventions of twelve weeks duration. The control arm is the provision of usual care following a coronary event, including both pharmacological intervention and lifestyle advice (usual care arm). The usual care for all trial participants will be delivered by the cardiovascular outpatient clinics available to all people following an acute coronary event in New Zealand. One active intervention is the provision of usual care and a weekly delivery of high fibre carbohydrate foods (healthy carbs arm). Tinned legumes, wholegrain foods, vegetables, and whole fruit will be delivered in sufficient amounts to feed the participant and those they live with. The purpose of the intervention is to provide sufficient quantity and choice that participants may choose from within the foods to suit their preferences. The second active intervention is the provision of usual care and the weekly delivery of foods high in healthy fats (healthy fats arm). Foods will be delivered to participant households though online supermarket grocery orders. Vegetable oil, margarine, tinned oily fish, nuts, seeds, and avocado will be delivered in sufficient amounts to feed the participant and those they live with. The purpose of the intervention is to provide sufficient quantity and choice that participants may choose from within the foods to suit their preferences. All participants will be required to use an online portal to enter demographic data, and attend pathology labs for body weight measurement and blood draw. Food will be delivered to the house of those participants in the intervention arms (healthy carbohydrate and healthy fats). There is minimal contact between the participants and investigators, and minimal additional contact between participants and services beyond accessing routine care, so to minimise the potential transmission of infectious diseases. Participants will have the contact details of the investigators at all times however, and be able to contact them remotely at anytime within the trial. Trial recruitment will be run out of these cardiovascular outpatient clinics in two regions of New Zealand, Otago and Southland. Intervention adherence will be assessed with gold standard dietary assessment techniques (Food Frequency Questionnaire for habitual food intake and food diaries during the interventions) as well as more novel objective biomarkers of dietary intakes pre and post interventions.
Sponsors
Dr Andrew Reynolds
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Adults who have had an acute coronary event.
Exclusion criteria
NA
Outcome results
None listed