The Effect of a Digital Heart Health App and Lifestyle Intervention for Heart Disease in Primary Care.

NCT ID: NCT06919302

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2035-06-01

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.

Conditions

Cardiovascular Diseases; Cardiovascular Risk Factors; Dyslipidemia; Cholesterol; Major Cardiovascular Event

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Digital Heart Health Program + Standard of Care

Group Type: EXPERIMENTAL

Digital Heart Health Program

Intervention Type: BEHAVIORAL

The 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.

Interventions

Digital Heart Health Program

The 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Laura Chiavaroli

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

C. David Naylor Building

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Laura Chiavaroli, PhD

Role: CONTACT

laura.chiavaroli@utoronto.ca

416-946-0579

John L Sievenpiper, MD, PhD

Role: CONTACT

john.sievenpiper@utoronto.ca

(416)867-7460

Facility Contacts

Laura Chiavaroli, PhD

Role: primary

laura.chiavaroli@utoronto.ca

416-946-0579

Antonio Rossi, MSc, PhD (c)

Role: backup

antonio.rossi@mail.utoronto.ca

416-946-0579

Other Identifiers

REB-44995

Identifier Type: -

Identifier Source: org_study_id