Despite the availability of medications, many people around the world continue to live with long-term health problems like heart disease, stroke and diabetes. In Canada, heart disease is a leading cause of death. Managing these health issues can be done by changing diet and lifestyle. Specific ways of eating have been proven to improve risk for heart disease and stroke. However, because doctors often have limited time, nutrition education, and lack of tools for counseling patients on nutrition, they can often only provide minimal support to help patients make necessary lifestyle changes. Digital tools and mobile applications offer an opportunity to involve doctors and patients in delivering nutrition interventions. This approach has the potential to save time, provide education, and reduce healthcare costs. This study is being done to understand the effect of a digital heart health program added to standard of care, compared with standard of care alone on heart health. All eligible participants in this study will be randomized (determined by chance) to one of two possible interventions: 1) a digital heart health program + standard of care; 2) standard of care. Standard is care is defined as the best practice based on guidelines for the treatment of a condition. All participants will be followed for seven years and will be asked to complete online questionnaires and complete blood work at their nearest LifeLabs clinic, as well as wear a continuous glucose monitor and wrist actigraph (at 3 time points in the first year). In addition, participants randomized to the digital heart health program + standard of care will be expected to use the heart health app and join 16 online synchronous sessions over the first year.
After seven years, the intervention phase of the study will end and the study will become a cohort study. All participants at the 7-year time point will be invited to use the heart health app. As part of the cohort study, participants will be asked to continue completing the same questionnaires online and completing bloodwork at their nearest LifeLabs every four years for the duration of their participation in the cohort study.
The main questions this study aims to answer are:
1. Will a digital heart health program added to standard of care result in a clinically meaningful reduction in blood cholesterol and other risk factors after 1-year compared to standard of care alone? 2. Will a digital heart health program added to standard of care result in a reduction in major cardiovascular events after 7-years compared to standard of care alone? 3. Are the observed effects sustained beyond the 7-years of the intervention?
We hypothesize that the digital heart health program added to standard of care will result in a clinically meaningful reduction in blood cholesterol and other risk factors for heart disease after 1-year and reduce major cardiovascular events after 7-years compared to standard of care alone.
Be taking statin medication with or without other antihyperlipidemic therapy (stable dose for at least 3-months).
Be on a stable dose for at least 3-months of all antihyperlipidemic, antihyperglycemic, antihypertensive, and antiobesity therapies.
Have a family physician in Ontario and a valid Ontario Health Card.
Have regular access to an online portal
Major disease expected to result in death within 2 years (except cardiovascular disease)
Active sever liver disease
Malabsorption disorders
Drug or alcohol abuse disorders (within past 6 months)
Parallel
Digital Heart Health Program
BehavioralThe digital heart health program will include the web-based app, which will deliver the intervention through interactive features (dashboard, goal setting, gamification, nudges, etc.) and will be supported by a 16-session synchronous online behaviour change program and provision of key study foods.
Proportion achieving a ≥8% reduction in LDL-C or non-HDL-C
Proportion of participants who achieve a ≥8% reduction in LDL-C or non-HDL-C in the intervention group compared to standard of care at 1-year. (If this is not achieved, we will then assess the difference in the proportion achieving ≥8% reduction in LDL-C or non-HDL-C and ≥5mmHg reduction in systolic blood pressure. If this is not achieved, we will then assess the difference in the proportion achieving ≥8% reduction in LDL-C or non-HDL-C and ≥10% reduction in the inflammatory marker, CRP.)
Major Cardiovascular Events
Major cardiovascular events in the intervention group compared to standard of care at 7-years.
Dietary Adherence
Proportion of participants who achieves ≥12/25-pt Diet Score, in the intervention group compared to standard of care at 1-year and 7-years. The Diet Score will be assessed using the Harvard Willett food frequency questionnaire.
Proportion achieving a ≥8% reduction in LDL-C or non-HDL-C
Proportion of participants who achieve a ≥8% reduction in LDL-C or non-HDL-C in the intervention group compared to standard of care at 7-years.
Proportion achieving established lipid targets for LDL-C or non-HDL-C
Proportion of participants who achieve Canadian Cardiovascular Society targets for LDL-C (\<2.0mmol/L for primary \<1.8mmol/L for secondary prevention) or non-HDL-C (\<2.6mmol/L for primary and \<2.4mmol/L for secondary prevention) in the intervention group compared to standard of care at 1-year and 7-years.
Blood Lipids
Changes in LDL-C, non-HDL-C, HDL-C, triglycerides and apoB levels in the intervention group compared to standard of care at 1-year and 7-years
Changes in Anti-Hypertension Medications
Changes in anti-hypertension medications in the intervention group compared to the standard of care at 1-year and 7-years
Changes in Anti-Hyperglycemic Medications
Changes in anti-hyperglycemic medications in the intervention group compared to the standard of care at 1-year and 7-years
Changes in Glycaemia
Changes in ambulatory glucose measured via a continuous glucose monitor in the intervention group compared to the standard of care at 1-year
Changes in Sleep
Changes in sleep using actigraphy in the intervention group compared to the standard of care at 1-year
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University of Toronto
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
