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

NCT06919302 | Recruiting

• 1 other identifier: REB-44995
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Are the observed effects sustained beyond the 7-years of the intervention?

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

Outcome Measures

Primary Outcomes (2)

• 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.)

  from enrollment to 1-year

• Major Cardiovascular Events

  Major cardiovascular events in the intervention group compared to standard of care at 7-years.

  from enrollment to 7-years

Secondary Outcomes (19)

• Dietary Adherence

  from enrollment to 1-year and 7-years

• Proportion achieving a ≥8% reduction in LDL-C or non-HDL-C

  from enrollment to 7-years

• Proportion achieving established lipid targets for LDL-C or non-HDL-C

  from enrollment to 1-year and 7-years

• Blood Lipids

  from enrollment to 1-year and 7-years

• Changes in Lipid-Lowering Medications

  from enrollment to 1-year and 7-years

Other Outcomes (13)

• Changes in Anti-Hypertension Medications

  from enrollment to 1-year and 7-years

• Changes in Anti-Hyperglycemic Medications

  from enrollment to 1-year and 7-years

• Changes in Glycaemia

  from enrollment to 1-year

Study Arms (2)

Standard of Care

NO INTERVENTION

Digital Heart Health Program + Standard of Care

EXPERIMENTAL

Behavioral: Digital Heart Health Program

Interventions

Digital Heart Health Program 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.

Digital Heart Health Program + Standard of Care

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

C. David Naylor Building

Toronto, Ontario, M5S1A8, Canada

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Laura Chiavaroli, PhD

CONTACT

416-946-0579; laura.chiavaroli@utoronto.ca

John L Sievenpiper, MD, PhD

CONTACT

(416)867-7460; john.sievenpiper@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will be blinded to the nature of the treatment when analyzing data (i.e., will not know the treatment assignment).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 9, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): June 1, 2034
• Study Completion (Estimated): June 1, 2035
• Last Updated: November 26, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD and supporting information will be available after the anticipated study completion date from 2035 and will remain for 30 years.
• Access Criteria: IPD data will be accessible though the University of Toronto Dataverse (https://borealisdata.ca/dataverse/toronto). The metadata record of our dataset will be public, however access to the data will be restricted. Users will need to request access using the contact information provided in order to view and download our restricted files.

Locations

CA (1)