Design, rationale, and characterization of the mobile health based occupational cardiovascular risk intervention study (mHealth-OPEN study) - 08/03/25
Highlights |
• | The mHealth-OPEN trial is a workplace-based cardiovascular risk intervention trial. |
• | A PMT-based comprehensive intervention, tailored to individuals, encourages active participation. |
• | Mobile health-based interventions are highly feasible. |
• | 10,000 participants were cluster-randomized across 20 workplaces. |
• | The effectiveness of these interventions can be assessed through this ongoing study. |
ABSTRACT |
Background |
The substantial workforce and suboptimal cardiovascular health highlights the urgent need for workplace interventions. This ongoing cluster-randomized trial aims to evaluate the effectiveness, feasibility, and acceptability of a mobile health (mHealth) based comprehensive intervention program to improve cardiovascular health among employees.
Methods and results |
We conducted a 1-year, 2-arm, parallel-group, cluster-randomized controlled multicenter trial involving 10,000 participants (aged 18-65, including 1,600 participants with high cardiovascular risk) across 20 workplaces. Workplaces were randomly assigned in a 1:1 ratio to either the intervention or control group. We established a mHealth based multifaceted cardiovascular risk management system that enables intelligent management. The intervention groups received a mHealth-based management with primary prevention inventions for all participants and additional cardiovascular risk interventions for participants with high cardiovascular risk via the system. The control groups received usual care. Primary outcomes included percentage changes in hypertension, diabetes, and dyslipidemia control rates among participants with high cardiovascular risk, and percentage changes in the rate of regular physical activity among all the participants, from baseline to 12-month follow-up. Secondary outcomes included changes in blood pressure, glucose, lipid, treatment adherence, behavioral factors, questionnaire scores, and incidence of major cardiovascular events. By now, baseline recruitment has been completed, with comparable characteristics between management and control groups.
Conclusions |
This rigorous designed mHealth-based workplace intervention demonstrates potential for nationwide implementation, offering cardiovascular benefits for employees.
Clinical trial registration |
www.chictr.org.cn. Identifier: ChiCTR2200066196.
Le texte complet de cet article est disponible en PDF.Graphical Abstract |
Plan
Vol 284
P. 32-41 - juin 2025 Retour au numéro
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