Currently submitted to: JMIR Research Protocols
Date Submitted: Feb 18, 2026
Open Peer Review Period: Feb 18, 2026 - Apr 15, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effect of a Mobile PA Monitoring Application on Metabolic Syndrome Management in Primary Care: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Digital health interventions, including mobile applications and wearable devices, have emerged as promising tools to promote physical activity (PA) and support chronic disease management in primary care. However, evidence remains limited regarding the real-world feasibility, patient engagement, and integration of these tools into routine family medicine practice, particularly in individuals with metabolic syndrome. In addition, physicians’ attitudes and intentions toward telemedicine may influence the successful adoption of such interventions.
Objective:
This study aims to evaluate the preliminary effectiveness of a mobile health intervention for PA monitoring in individuals with metabolic syndrome managed in primary care. Secondary objectives include assessing user engagement and adherence to the intervention, changes in PA-related and clinical outcomes, and exploring family physicians’ attitudes and behavioral intentions toward telemedicine.
Methods:
This is a two-arm, parallel, pilot randomized controlled trial conducted in primary care units in the Coimbra region, Portugal. Eligible adults with metabolic syndrome will be randomized (1:1) to an intervention group receiving access to a mobile application integrated with an activity-tracking wristband or to a control group receiving usual care. Data will be collected at baseline and 6 months. Primary outcomes include changes in PA levels and physical literacy, assessed through validated questionnaires and objective analitical results. Secondary outcomes comprise health-related quality of life, cardiometabolic parameters, adherence and engagement metrics derived from app usage, retention and dropout rates. Physicians’ attitudes and intentions regarding telemedicine will be assessed using the Physician Attitudes and Intention to use Telemedicine (PAIT) questionnaire. Analyses will primarily be descriptive and exploratory, aiming to inform the design of a future full-scale trial.
Results:
Participant recruitment is planned to begin in July 2025. This pilot trial will generate data on feasibility, adherence, engagement, and preliminary behavioral and clinical outcomes associated with the use of a mobile PA monitoring intervention in primary care.
Conclusions:
This study will provide important insights into integrating mobile health applications for PA promotion among individuals with metabolic syndrome in routine primary care. The findings will inform future larger randomized controlled trials and contribute to implementation strategies for digital health interventions in family medicine. Clinical Trial: EECC-2024_4-220 e 335/25 CE
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