Cardiovascular DiseasesCHEAPNCT06919302
The Effect of a Digital Heart Health App and Lifestyle Intervention for Heart Disease in Primary Care.
A study testing Digital Heart Health Program in people with Cardiovascular Diseases and Cardiovascular Risk Factors, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factors, Dyslipidemia
- What is being tested?
- Digital Heart Health Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteCanada
- Study dates
- 15 Aug 2025to 1 Jun 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
C. David Naylor Building
Toronto, Ontario, M5S1A8
Laura Chiavaroli, PhD, 416-946-0579, laura.chiavaroli@utoronto.ca
Antonio Rossi, MSc, PhD (c), 416-946-0579, antonio.rossi@mail.utoronto.ca
About this study
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
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.
Read more
The main questions this study aims to answer are:
- 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?
- 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?
- 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
- Being tested
- Digital Heart Health Program
- Keywords
- randomized controlled trial, digital heart health program, heart health app, web-based app, large-scale study
- Medical subject headings
- Cardiovascular Diseases, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Heart Health ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Not described |
| Digital Heart Health Program + Standard of Care | Experimental | Not described Receives: Behavioral: Digital Heart Health Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: from enrollment to 1-year
Major Cardiovascular Events
Major cardiovascular events in the intervention group compared to standard of care at 7-years.
Measured: from enrollment to 7-years
Secondary outcomes (19)
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.
Measured: from enrollment to 1-year and 7-years
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.
Measured: from enrollment to 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.
Measured: from enrollment to 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
Measured: from enrollment to 1-year and 7-years
Changes in Lipid-Lowering Medications
Changes in lipid-lowering medications in the intervention group compared to standard of care at 1-year and 7-years
Measured: from enrollment to 1-year and 7-years
Changes in Glycemia
Changes in HbA1c in the intervention group compared to the standard of care at 1-year and 7-years
Measured: from enrollment to 1-year and 7-years
Changes in Glycemia
Changes in fasting blood glucose levels in the intervention group compared to the standard of care at 1-year and 7-years
Measured: from enrollment to 1-year and 7-years
Changes in Insulin Resistance
Changes in HOMA-IR in the intervention group compared to the standard of care at 1-year and 7-years
Measured: from enrollment to 1-year and 7-years
Changes in Insulin
Changes in fasting blood insulin levels in the intervention group compared to the standard of care at 1-year and 7-years
Measured: from enrollment to 1-year and 7-years
Changes in Measures of Adiposity
Changes in body weight in the intervention group compared to the standard of care at 1-year and 7-years
Measured: from enrollment to 1-year and 7-years
Changes in Measures of Adiposity
Changes in body mass index in the intervention group compared to the standard of care at 1-year and 7-years
Measured: from enrollment to 1-year and 7-years
Changes in Measures of Adiposity
Changes in waist circumference in the intervention group compared to the standard of care at 1-year and 7-years
Measured: from enrollment to 1-year and 7-years
Changes in Systolic Blood Pressure
Changes in systolic blood pressure in the intervention group compared to the standard of care at 1-year and 7-years
Measured: from enrollment to 1-year and 7-years
Changes in Diastolic Blood Pressure
Changes in diastolic blood pressure in the intervention group compared to the standard of care at 1-year and 7-years
Measured: from enrollment to 1-year and 7-years
Changes in Inflammation
Changes in c-reactive protein (CRP) levels in the intervention group compared to the standard of care at 1-year and 7-years
Measured: from enrollment to 1-year and 7-years
Cost-Effectiveness - quality-adjusted life years (QALYs)
Changes in quality-adjusted life years (QALYs) assessed using the EQ5D-5L in the intervention group compared to standard of care at 1-year and 7-years
Measured: from enrollment to 1-year and 7-years
Cost-Effectiveness - medical resource utilization
Changes in medical resources utilization (Canadian dollars) in the intervention compared to standard of care at 1-year and 7-years.
Medical resource utilization encompassing primary care, hospital care, specialist care, and medications for individuals covered by public drug insurance will be obtained from Ontario health administrative databases housed at ICES (formerly the Institute for Clinical Evaluative Sciences).
Measured: from enrollment to 1-year and 7-years
Cost-Effectiveness - out-of-pocket food and medical costs
Changes in out-of-pocket food and medical costs in the intervention group compared to the standard of care at 1-year and 7-years
Measured: from enrollment to 1-year and 7-years
Cost-utility
Costs / point change in QALY in the intervention group compared to the standard of care at 1-year and 7-years
Measured: from enrollment to 1-year and 7-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start15 Aug 2025
- Primary completion1 Jun 2034 (estimated)
- Study completion1 Jun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Laura Chiavaroli, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919302
- Sponsor's protocol ID
- REB-44995
- Acronym
- CHEAP
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All outcomes listed will be shared in an anonymous/de-identified format.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06919302
- Acronym / sponsor ID
- CHEAP / REB-44995
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Jun 2034 (estimated)
- Study completion
- 1 Jun 2035 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | – |
| Digital Heart Health Program + Standard of Care | Experimental | Behavioral: Digital Heart Health Program |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Heart Health ProgramThe 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. | Behavioural | Digital Heart Health Program + Standard of Care |
Primary outcome
Proportion achieving a ≥8% reduction in LDL-C or non-HDL-C
Time frame: from enrollment to 1-year
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
Time frame: from enrollment to 7-years
Major cardiovascular events in the intervention group compared to standard of care at 7-years.
19 secondary outcomes
Dietary Adherence
Time frame: from enrollment to 1-year and 7-years
Proportion achieving a ≥8% reduction in LDL-C or non-HDL-C
Time frame: from enrollment to 7-years
Proportion achieving established lipid targets for LDL-C or non-HDL-C
Time frame: from enrollment to 1-year and 7-years
Blood Lipids
Time frame: from enrollment to 1-year and 7-years
Changes in Lipid-Lowering Medications
Time frame: from enrollment to 1-year and 7-years
Changes in Glycemia
Time frame: from enrollment to 1-year and 7-years
Changes in Glycemia
Time frame: from enrollment to 1-year and 7-years
Changes in Insulin Resistance
Time frame: from enrollment to 1-year and 7-years
Changes in Insulin
Time frame: from enrollment to 1-year and 7-years
Changes in Measures of Adiposity
Time frame: from enrollment to 1-year and 7-years
Changes in Measures of Adiposity
Time frame: from enrollment to 1-year and 7-years
Changes in Measures of Adiposity
Time frame: from enrollment to 1-year and 7-years
Changes in Systolic Blood Pressure
Time frame: from enrollment to 1-year and 7-years
Changes in Diastolic Blood Pressure
Time frame: from enrollment to 1-year and 7-years
Changes in Inflammation
Time frame: from enrollment to 1-year and 7-years
Cost-Effectiveness - quality-adjusted life years (QALYs)
Time frame: from enrollment to 1-year and 7-years
Cost-Effectiveness - medical resource utilization
Time frame: from enrollment to 1-year and 7-years
Cost-Effectiveness - out-of-pocket food and medical costs
Time frame: from enrollment to 1-year and 7-years
Cost-utility
Time frame: from enrollment to 1-year and 7-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Yes. All outcomes listed will be shared in an anonymous/de-identified format.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Heart Health Program in people with Cardiovascular Diseases and Cardiovascular Risk Factors, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Chiavaroli, PhD (416-946-0579, laura.chiavaroli@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion achieving a ≥8% reduction in LDL-C or non-HDL-C (time frame: from enrollment to 1-year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.