Simulation Model to Assess the Validity of the Clinical Portfolio Diet Score Used in the PortfolioDiet.app for Dietary Self-tracking: a Secondary Analysis of a Randomized Controlled Trial in Hyperlipidemic Adults

Introduction: The Portfolio Diet combines cholesterol-lowering plant foods for the management of cardiovascular disease risk. However, the translation of this dietary approach into clinical practice necessitates a user-friendly method for patients to autonomously monitor their adherence.

Objective: This study aimed to develop and validate the clinical-Portfolio Diet Score (c-PDS) as a food-based metric to facilitate self-tracking of the Portfolio Diet.

Methods: Using a simulation model to estimate the c-PDS, the validity was assessed in a secondary analysis of a completed trial of the Portfolio Diet in 98 participants with hyperlipidemia over 6 months. Concurrent and predictive validity of the estimated c-PDS were assessed against the reference measure (weighed 7-day diet records) and concomitant changes in LDL-C from baseline to 6 months. Bland-Altman analysis was used to assess the limits of agreement between the two methods.

Results: The c-PDS was positively correlated with dietary adherence as measured using the 7-day diet records ( = 0.94,  < 0.001). The c-PDS was negatively correlated with change in LDL-C ( = -0.43,  < 0.001) with a 1-point increase in the c-PDS being associated with a - 0.04 mmol/L (CI:-0.06,-0.03;  < 0.001) or a 1.09% reduction in LDL-C. Visual evaluation of the Bland-Altman plots showed reasonable agreement.

Conclusion: These findings indicate good validity of the c-PDS for primary prevention in adults with hyperlipidemia. The predictive validity findings have informed the goals and messaging within the PortfolioDiet.app, a digital health application for delivering the Portfolio Diet. Future research will assess the effectiveness of the intended combination of the c-PDS and the PortfolioDiet.app in supporting behavior change.