(P22-010-23) Coronary Heart Effectiveness Assessment of the Portfolio Diet in Primary Care (CHEAP) Trial: Protocol for a Randomized Controlled Trial

Objectives: The Portfolio Diet, a cholesterol-lowering, plant-based dietary pattern, has shown clinically meaningful reductions in LDL-C and other cardiovascular risk factors. Our objective is to present the protocol for our trial to assess the impact of the Portfolio Diet Program, designed to help patients meet Canadian Cardiovascular Society (CCS) clinical practice guideline targets for lipids and cardiovascular risk using the novel PortfolioDiet.app with online behavioural support delivered in primary care.

Methods: We will conduct a pragmatic, 2-arm, open-label, randomized controlled trial. Physicians will be recruited through a primary care research network (UTOPIAN) to identify 1000 secondary [70%] and high-risk primary [30%] prevention participants on background statin therapy to randomize to either the Portfolio Diet Program as add-on therapy to standard of care or standard of care alone. The Portfolio Diet Program will deliver the intervention through the PortfolioDiet.app via interactive features (dashboard, goal setting, gamification, nudges, etc.) and a 16-session online behaviour change curriculum. A stepwise gatekeeping procedure will be used to assess two primary outcomes:  proportion achieving a ≥8% reduction in LDL-C or non-HDL-C at 1-year, and major cardiovascular events at 7-year.  If superiority of the intervention is shown by the first primary outcome at 1-year, the trial will continue to assess the second primary outcome at 7-year. Secondary outcomes will be diet adherence, proportion achieving CCS therapeutic targets, medication changes, patient and provider experience, and cost-effectiveness. Primary outcomes will be obtained from blood samples via requisitions and ICES administrative data and secondary outcomes from online questionnaires and electronic medical records. The Applied Health Research Centre will manage data.

Results: N/A - protocol abstract

Conclusions: Demonstrating the Portfolio Diet Program reduces established lipid targets and cardiovascular risk, while improving the patient and provider experience and reducing health care costs, will have major influence on the implementation of clinical practice guidelines in primary care. The Portfolio Diet Program will deliver a ready-to-use clinical tool for patients and providers, which will be made freely available through CCS

Funding Sources: Canadian Institutes of Health Research