Trials / Active Not Recruiting
Active Not RecruitingNCT07236450
Use of a Mobile Application for Tracking Physical Activity in the Management of Metabolic Syndrome in Primary Care
Exploring the Role of a Mobile Application for Physical Activity Tracking in the Management of Metabolic Syndrome in Primary Care
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Andreia Lobo · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will explore whether integrating a mobile app to track physical activity-recommended by family doctors during routine primary care visits-can help individuals with metabolic syndrome become more active. Participants will be randomly assigned to one of two groups: the intervention group will use the mobile app combined with an activity-tracking wristband; the control group will receive usual care without digital tools. Family doctors will introduce and support the use of the mobile app during standard consultations. The study will also assess physicians' perceptions of using digital technologies, such as mobile apps and telemedicine, to encourage physical activity. Researchers will monitor the frequency of app use, step counts and changes in physical activity habits over time. The primary goal is to determine whether digital health tools can be feasibly implemented in primary care to promote healthier lifestyles and improve chronic disease management in people with metabolic syndrome.
Detailed description
This study examines the impact of a mobile application for tracking physical activity (PA) on the management of metabolic syndrome in a primary care setting. It also explores family physicians' attitudes and behavioral intentions regarding the adoption of telemedicine tools for health promotion. This is a two-arm, parallel-group, superiority randomized controlled pilot study. Adult patients diagnosed with metabolic syndrome, who own a compatible smartphone, will be recruited from primary care units. Eligible participants will be randomly assigned to one of two groups: an intervention group, receiving a mobile health application (Polis Saúde®) integrated with a wearable PA-tracking device (Fitbit Inspire 3), or to a control group receiving the usual care without digital tools. Follow-up assessments will be conducted at baseline and 6 months. The mobile application offers personalized motivational messages, health education content, and real-time PA monitoring. Data will be collected on app usage, engagement with motivational content, step counts, and participant feedback. Clinical and anthropometric data, such as lipid profiles, fasting glucose, blood pressure, BMI, and waist circumference, will also be collected. Primary outcomes include adherence to the intervention (app usage, engagement with motivational content), retention, step count data, and dropout rates. Secondary outcomes include assessment of physical literacy, PA habits (via IPAQ), app usage metrics (frequency, session duration, feedback responses, completion and dismissal rates, etc). The study will further assess family physicians' attitudes and intentions toward telemedicine (using the PAIT questionnaire). Data will be analyzed using descriptive and inferential statistics, including regression and survival models. The study aims to assess the feasibility, adherence, and potential effectiveness of mobile health technologies for promoting PA and managing chronic conditions in primary care. It will also provide insights into the behavioral determinants of physician adoption of digital health tools. The findings will inform future large-scale trials and contribute to clinical strategies and public health policies that integrate digital health solutions into chronic disease care.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Mobile Application and Wearable Device for Physical Activity Monitoring | This intervention consists of a mobile health application (Polis Saúde®) integrated with a wearable activity tracker (Fitbit Inspire 3) designed to support physical activity monitoring and behavior change in adults with metabolic syndrome. The mobile application delivers personalized motivational messages and educational content twice weekly and records user engagement, including app usage and interaction with content. The wearable device continuously tracks step count and synchronizes data with the app. Participants are encouraged to use the app and device daily over a 6-month period. Data on adherence, physical activity, and health metrics will be collected to evaluate the impact on lifestyle and clinical outcomes. |
Timeline
- Start date
- 2025-07-24
- Primary completion
- 2026-02-01
- Completion
- 2026-02-01
- First posted
- 2025-11-19
- Last updated
- 2026-01-08
Locations
1 site across 1 country: Portugal
Source: ClinicalTrials.gov record NCT07236450. Inclusion in this directory is not an endorsement.