Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-29 @ 7:50 AM
Study NCT ID:
NCT07236450
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of a Mobile Application for Tracking Physical Activity in the Management of Metabolic Syndrome in Primary Care
Sponsor:
Andreia Lobo
Organization:
Study Overview
Official Title:
Exploring the Role of a Mobile Application for Physical Activity Tracking in the Management of Metabolic Syndrome in Primary Care
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMAFIL
Brief 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.
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, 3 months, 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.
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, 3 months, 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: