Clinical trial NCT06919302: The Effect of a Digital Heart Health App and Lifestyle Intervention for Heart Disease in Primary Care.
Official title: An Innovative Technology-based Approach to Translating Clinical Practice Guidelines of Nutrition Therapy in Primary Care: The Coronary Heart Effectiveness Assessment of the Portfolio Diet in Primary Care (CHEAP) Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Cardiovascular Risk Factors
Dyslipidemia
Cholesterol
Major Cardiovascular Event
Keywords: randomized controlled trial
digital heart health program
heart health app
web-based app
large-scale study
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2025-04-09
Enrollment: 1100
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Be taking statin medication with or without other antihyperlipidemic therapy (stable dose for at least 3-months).
* Fall under either of the 2 categories:

  1) Secondary prevention participants: males and females ≥45 years of age with established atherosclerotic cardiovascular disease (ASCVD) defined as at least one of the following: i. Prior myocardial infarction (MI); ii. Acute coronary syndrome (ACS); iii. Stroke/TIA; iv. Coronary revascularization; v. Documented carotid disease (endarterectomy, carotid stenosis ≥50%); vi. Stable angina; vii. Coronary artery disease (CAD) by angiography; viii. Peripheral artery disease (PAD); ix. Abdominal aortic aneurysm (AAA)

  2) High-risk primary prevention participants: males and females ≥50 years of age plus type 2 diabetes requiring treatment with medication and at least one additional risk factor: i. Males ≥55 years of age and females ≥65 years of age; ii. Cigarette smoker or stopped smoking within 3 months before Visit 1; iii. Hypertension and on antihypertensive medication for at least 6-months; iv. Chronic kidney disease (CKD); v. Retinopathy, defined as any of the following: non-proliferative retinopathy, pre-proliferative retinopathy, proliferative retinopathy, maculopathy, advanced diabetic eye disease or a history of photocoagulation
* 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
* Be proficient in English.

Exclusion Criteria:

* 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)
* Intolerance or allergies to soy protein and tree nuts, peanuts, or seeds
* Planned coronary intervention or any major surgical procedure
* Participation in another clinical trial (within past 3 months)
* End stage renal disease (requirement for peritoneal dialysis or hemodialysis for renal insufficiency or eGFR \<30 mL/min)
* Any condition or therapy which might pose a risk to the patient or make participation in the study not be in the best interest of the patient as assessed by the investigator
* Documented severe (New York Heart Association \[NYHA\] class IV) heart failure
* Mental/psychological impairment expected to affect adherence to the study protocol
* Known AIDS (HIV-positive patients without AIDS are allowed)
* Women planning on becoming pregnant within the first year of the intervention
* Unable to provide informed consent: Appear unable to comprehend the study protocol during the interview process or to understand and communicate in English sufficiently for informed consent.

Primary outcomes:
measure: Proportion achieving a ≥8% reduction in LDL-C or non-HDL-C
timeFrame: from enrollment to 1-year
measure: Major Cardiovascular Events
timeFrame: from enrollment to 7-years
Secondary outcomes:
measure: Dietary Adherence
timeFrame: from enrollment to 1-year and 7-years
measure: Proportion achieving a ≥8% reduction in LDL-C or non-HDL-C
timeFrame: from enrollment to 7-years
measure: Proportion achieving established lipid targets for LDL-C or non-HDL-C
timeFrame: from enrollment to 1-year and 7-years
measure: Blood Lipids
timeFrame: from enrollment to 1-year and 7-years
measure: Changes in Lipid-Lowering Medications
timeFrame: from enrollment to 1-year and 7-years
measure: Changes in Glycemia
timeFrame: from enrollment to 1-year and 7-years
measure: Changes in Glycemia
timeFrame: from enrollment to 1-year and 7-years
measure: Changes in Insulin Resistance
timeFrame: from enrollment to 1-year and 7-years
measure: Changes in Insulin
timeFrame: from enrollment to 1-year and 7-years
measure: Changes in Measures of Adiposity
timeFrame: from enrollment to 1-year and 7-years
measure: Changes in Measures of Adiposity
timeFrame: from enrollment to 1-year and 7-years
measure: Changes in Measures of Adiposity
timeFrame: from enrollment to 1-year and 7-years
measure: Changes in Systolic Blood Pressure
timeFrame: from enrollment to 1-year and 7-years
measure: Changes in Diastolic Blood Pressure
timeFrame: from enrollment to 1-year and 7-years
measure: Changes in Inflammation
timeFrame: from enrollment to 1-year and 7-years
measure: Cost-Effectiveness - quality-adjusted life years (QALYs)
timeFrame: from enrollment to 1-year and 7-years
measure: Cost-Effectiveness - medical resource utilization
timeFrame: from enrollment to 1-year and 7-years
measure: Cost-Effectiveness - out-of-pocket food and medical costs
timeFrame: from enrollment to 1-year and 7-years
measure: Cost-utility
timeFrame: from enrollment to 1-year and 7-years
Other outcomes:
measure: Changes in Anti-Hypertension Medications
timeFrame: from enrollment to 1-year and 7-years
measure: Changes in Anti-Hyperglycemic Medications
timeFrame: from enrollment to 1-year and 7-years
measure: Changes in Glycaemia
timeFrame: from enrollment to 1-year
measure: Changes in Sleep
timeFrame: from enrollment to 1-year
measure: Changes in Sleep
timeFrame: from enrollment to 1-year and 7-years
measure: Safety - Self-Reported Adverse Events
timeFrame: from enrollment to 1-year and 7-years
measure: Incidence of Type 2 Diabetes
timeFrame: from enrollment to 7-years
measure: Type 2 Diabetes Remission
timeFrame: from enrollment to 7-years
measure: Incidence of Metabolic Syndrome
timeFrame: from enrollment to 7-years
measure: Metabolic Syndrome Remission
timeFrame: from enrollment to 7-years
measure: Incidence of Hypertension
timeFrame: from enrollment to 7-years
measure: Incidence of Cancer
timeFrame: from enrollment to 7-years
measure: Incidence of Dementia
timeFrame: from enrollment to 7-years
Locations:
city: Toronto
country: Canada
facility: C. David Naylor Building
state: Ontario
Study officials:
References: