A self-guided digital health application for LDL-cholesterol reduction in adults with hypercholesterolaemia (the DIGICHOL randomised controlled trial)

Structured lifestyle modification is the guideline-mandated foundation of lipid management but is rarely delivered in routine care. We evaluated lipodia, a fully self-guided digital health application providing structured lifestyle support, in a pragmatic randomised controlled trial conducted online. Adults with LDL-cholesterol above their risk-adapted target (n = 278) were randomised 1:1 to usual care plus lipodia or usual care alone. After six months, lipodia significantly reduced LDL-cholesterol relative to usual care (adjusted between-group difference in relative change -3.9%; p = 0.029), with nearly twice as many users achieving a clinically meaningful reduction of at least 10% (41.7% versus 23.8%; p = 0.002). lipodia also significantly improved patient activation, non-HDL-cholesterol, and health-related quality of life, with high uptake, low attrition, and no adverse device effects. As a self-guided tool, lipodia provides a scalable and guideline-concordant means of delivering structured lifestyle support that is rarely available in routine care.