Digital heart-health app and lifestyle program for adults with heart disease or high-risk diabetes
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
NA · University of Toronto · NCT06919302
This program will test whether adding a digital heart-health app and lifestyle support to usual care helps adults on statins with established heart disease or high-risk type 2 diabetes lower their cardiovascular risk.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | University of Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06919302 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study compares a digital heart-health program plus standard primary care to standard care alone in adults taking statin therapy. Participants use a web- and mobile-based app that provides nutrition and lifestyle guidance alongside routine clinical follow-up. Eligible participants are adults on a stable statin dose with either established atherosclerotic cardiovascular disease or older adults with treated type 2 diabetes and additional risk factors. The study will track changes in cardiovascular risk factors and related health measures over the follow-up period.
Who should consider this trial
Good fit: Adults on a stable statin dose for at least three months who have either established atherosclerotic cardiovascular disease (age ≥45) or are age ≥50 with treated type 2 diabetes plus additional risk factors are ideal candidates.
Not a fit: People not on stable statin therapy, those without cardiovascular disease or high-risk diabetes, or those unable or unwilling to use a smartphone or web app are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the digital program could help patients improve diet and risk factors and possibly reduce future heart problems while saving clinician time.
How similar studies have performed: Similar digital lifestyle and app-based programs have shown modest improvements in risk factors like weight and blood pressure, but large-scale evidence for reducing major cardiovascular events remains limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toronto, Ontario
- C. David Naylor Building — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Laura Chiavaroli, PhD
- Email: laura.chiavaroli@utoronto.ca
- Phone: 416-946-0579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiovascular Diseases, Cardiovascular Risk Factors, Dyslipidemia, Cholesterol, Major Cardiovascular Event, randomized controlled trial, digital heart health program, heart health app