Digital lifestyle re-engineering with maintenance phase design: The TOP-S randomised clinical trial in metabolic syndrome management

Introduction Sustained lifestyle modification is essential for lifelong management of metabolic syndrome (MetS). However, high attrition rate reaching 40% in prior lifestyle intervention trials examining the long-term effects of lifestyle interventions undermines the robustness of evaluation. To address this, we developed the ‘Tailored, Optimised, Person-centred Sustainable lifestyle modification’(TOP-S) intervention designed to sustain engagement and cardiometabolic benefits beyond the active intervention. Purpose To evaluate the effects of TOP-S intervention on MetS components. Methods In this assessor-blinded, two-arm parallel randomised controlled trial conducted at six community centres, adults with MetS, defined by the ‘Harmonizing the metabolic syndrome’ criteria, were randomly allocated (1:1) to a single structured lifestyle advice session (control) or the TOP-S intervention, which is grounded in person-centred care and offers support in two critical stages: a 12-week active intervention involving personalised lifestyle re-engineering delivered through digital resources supplemented by fortnightly nurse counselling, and a four-week lived experience phase with minimal clinical support to simulate real-life maintenance. Study outcomes included the number of MetS components present, individual MetS components (waist circumference, blood pressure, triglycerides, high-density lipoprotein cholesterol, and fasting blood glucose), and blood lipid measures (total cholesterol and low-density lipoprotein cholesterol [LDL-C]). Results At two months post-intervention, the attrition rate was 5.3%, with a 91% attendance rate of counselling sessions in the TOP-S group. Among 133 participants randomised (TOP-S: n = 67; control: n = 66), the TOP-S group demonstrated significantly greater reduction in the number of MetS components present compared to the control group at two months post-intervention (Time*group effect: β = -0.330, 95% confidence interval [CI] -0.648, -0.011, p = 0.046, Figure 1). A significantly greater reduction in waist circumference was observed in the TOP-S group compared to the control group (β = -1.970, 95% CI [-3.511, -0.430], p = 0.012) at two months post-intervention. No significant time-by-group interaction effects were observed for other MetS components at two months post-intervention. However, the TOP-S group exhibited significantly greater reductions in total cholesterol (β = -0.358, 95% CI [-0.606, -0.109], p = 0.005) and LDL-C (β = -0.234, 95% CI [-0.451, -0.016], p = 0.035) at the completion of active intervention, but these effects were not sustained two months later (p > 0.05). Conclusion Our study provides the first empirical evidence that a person-centred digital intervention with maintenance phase design can sustain cardiometabolic improvements beyond active treatment, warranting the completion of the full trial and further exploration for strategies to optimise the sustainability of intervention efficacy.For image description, please refer to the figure legend and surrounding text.