mHealth-based Healthy Lifestyle Promotion (MYLIFE) for metabolic syndrome risk reduction in Chinese employed adults: protocol for a cluster-randomised controlled trial

Introduction Metabolic syndrome (MetS) poses a significant public health challenge among employed adults. Lifestyle modifications have been shown to be effective in preventing the onset and progression of MetS in employed adults, and the widespread adoption of mobile and wearable technologies introduces an appealing approach to mHealth lifestyle interventions. When widely implementing smartphone-based interventions for employed adults, enhancing equitable access and promoting wearable device use for those with MetS is a more cost-effective way to reduce health disparities, particularly in resource-limited settings. However, relevant evidence is currently lacking. Objective This study aims to design an mHealth-based Healthy Lifestyle Promotion (MYLIFE) trial, a three-arm randomised controlled trial (RCT), to evaluate the effectiveness of a smartphone-based lifestyle intervention and a combined smartphone-based lifestyle intervention with intensive intervention for MetS individuals using wearable devices, in reducing MetS risk among employed adults. Methods and analysis This is a three-arm, parallel, single-blind, cluster RCT with a 12-week intervention and a total follow-up of 1 year. The trial will recruit 120 workplaces from the Chinese Cohort of Working Adults in a 1:1:1 ratio to either a control group or one of two intervention groups. Within these workplaces, a total of at least 348 eligible participants will be enrolled. The regular mHealth group will receive smartphone-based intervention. The intensive mHealth group will receive smartphone-based intervention for all participants, and an additional wearable device-intensive intervention for those with MetS. The primary outcome is the Chinese MetS Z score at 12 weeks. Secondary outcomes include MetS Z score, prevalence of MetS, specific MetS components, questionnaire-based indicators, and clinical outcomes at 12 weeks and 1 years. The main analysis will follow the intention-to-treat principle, using mixed-effects models to assess between-group differences in outcomes. Ethics and dissemination The protocol has been approved by the Ethics Committee of the West China School of Public Health and the West China Fourth Hospital, Sichuan University (Gwll2025024). The findings will be published in peer-reviewed journals and presented at scientific conferences. Trial registration number ChiCTR2500101904.