mHealth-based Healthy Lifestyle Promotion (MYLIFE) for metabolic syndrome risk reduction in Chinese employed adults: protocol for a cluster-randomised controlled trial
Clinical Snapshot
PICO Framework
| P — Population | Chinese employed adults at risk for or with metabolic syndrome, recruited from 120 workplaces (minimum 348 participants) |
| I — Intervention | Three-arm comparison: (1) smartphone-based lifestyle intervention (regular mHealth), (2) smartphone-based intervention plus wearable device intensive intervention for MetS participants (intensive mHealth) |
| C — Comparator | Control group (standard care/no intervention specified) |
| O — Outcomes | Primary: Chinese MetS Z score at 12 weeks. Secondary: MetS prevalence, individual MetS components, questionnaire-based indicators, clinical outcomes at 12 weeks and 1 year |
Bottom Line
This cluster RCT protocol describes a pragmatic workplace-based mHealth intervention for metabolic syndrome prevention in Chinese employed adults. The three-arm design comparing standard smartphone intervention versus intensive intervention with wearables for high-risk individuals addresses an important implementation question. However, significant methodological limitations include single-blind design, unclear control group definition, and absence of power calculations. The Chinese-specific population and healthcare context limit direct applicability to Australian practice. While the research question is relevant and the cluster design appropriate for workplace interventions, the protocol lacks sufficient methodological rigor for definitive evidence generation. Results, when available, should be interpreted cautiously given these design limitations.
Key Findings
P Value: Not yet available - protocol publication
Effect Size: Not yet available - protocol publication
Primary Outcome: Chinese MetS Z score at 12 weeks (protocol stage - results pending)
Nnt Or Sensitivity: Not yet available - protocol publication
Confidence Interval: Not yet available - protocol publication
Clinical Application
Moderate - requires smartphone access and workplace engagement, may face implementation barriers in diverse work environments Limited direct applicability due to different healthcare systems and cultural contexts; would require adaptation for Australian workplace health programs and integration with existing preventive care pathways Employed adults with metabolic syndrome risk factors in workplace settings
Abstract
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.
References
- 1.Yu, B., Tang, Q., Hu, Y., Zuo, H., Yang, B., Pan, J., Jia, P., Reinhardt, J., & Yang, S. (2026). mHealth-based Healthy Lifestyle Promotion (MYLIFE) for metabolic syndrome risk reduction in Chinese employed adults: protocol for a cluster-randomised controlled trial. BMJ Open, 16(4). https://doi.org/10.1136/bmjopen-2025-109980
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