Use of a Mobile Application for Tracking Physical Activity in the Management of Metabolic Syndrome in Primary Care

NCT ID: NCT07236450

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-24
• Study Completion Date: 2026-02-01

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.

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

Metabolic Syndrome (MetS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care Without Digital Monitoring

Participants will receive usual primary care for the management of metabolic syndrome, without access to digital tools for physical activity monitoring. No mobile application or wearable device will be provided. Clinical follow-up will adhere standard practice guidelines, and no additional digital health interventions will be introduced throughout the study period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mobile Application and Wearable Device for Physical Activity Monitoring

Participants will receive usual primary care along with access to a mobile health application (Polis Saúde®) integrated with a wearable activity-tracking device (Fitbit Inspire 3). The application provides real-time physical activity monitoring, motivational messages, and educational content. Participants will be instructed to use the app and wearable device regularly throughout the 6-month study period. Engagement with the app, step count data, and interaction with motivational content will be tracked to assess adherence and behavior change.

Group Type: EXPERIMENTAL

Mobile Application and Wearable Device for Physical Activity Monitoring

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Fitbit Inspire 3; Mobile Health Application for Physical Activity Monitoring; Digital Health Intervention for Metabolic Syndrome; Polis Saúde App

Eligibility Criteria

Inclusion Criteria

• Adults aged 18 years or older;
• Diagnosed with metabolic syndrome;
• Presence of at least one of the following ICPC-2 (International Classification of Primary Care - 2nd edition), used in primary health care:codes in the medical record:

• T83 (Overweight) or T82 (Obesity), with waist circumference ≥ 94 cm (men) or ≥ 80 cm (women)
• T89 (Non-insulin-dependent diabetes)
• T93 (Lipid metabolism disorder: HDL < 40 mg/dl for men, < 50 mg/dl for women; or triglycerides ≥ 150 mg/dl)
• K86 (Hypertension without complications) or K87 (Hypertension with complications);
• Access to a smartphone compatible with the mobile application;
• Does not currently use any physical activity monitoring device (e.g., pedometer, smartwatch, fitness tracker);
• Willing and able to provide informed consent.

Exclusion Criteria

• No scheduled medical appointments in the past three years;
• Refusal to participate or withdraws consent;
• Change of primary care unit during the study period;
• Pregnant at the time of enrollment or becomes pregnant during the study;
• Diagnosed mental incapacity that prevents answering questionnaires;
• Does not own a smartphone;
• Inability to use a mobile application;
• Inability to use a physical activity tracking wristband.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Beira Interior

OTHER

Sponsor Role: collaborator

Centro Hospitalar Universitário de Coimbra

UNKNOWN

Sponsor Role: collaborator

Andreia Lobo

OTHER

Sponsor Role: lead

Responsible Party

Andreia Lobo

MD, Primary-care Physician, Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andreia Filipa Lobo, Master

Role: PRINCIPAL_INVESTIGATOR

Unidade Local de Saude de Coimbra

Locations

USF Cruz de Celas

Coimbra, Portugal, Portugal

Countries

Portugal

Other Identifiers

EECC-2024_4-220 e 335/25 CE

Identifier Type: -

Identifier Source: org_study_id