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

NCT07236450 | Completed

• 1 other identifier: EECC-2024_4-220 e 335/25 CE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome (MetS)

Keywords

Metabolic Syndrome; Physical Activity; Family Medicine; Mobile Health; mHealth; Mobile Application; Physical Activity Monitoring; Wearable Device; Digital Health; Self-Monitoring; Lifestyle Intervention; Exercise Promotion; Physical Literacy; Health Behavior; Patient Engagement

Outcome Measures

Primary Outcomes (17)

• Physical Literacy

  Physical literacy will be assessed using the Perceived Physical Literacy Instrument (PPLI-PT), a validated questionnaire evaluating motivation, confidence, knowledge, and participation in physical activity (5-point Likert scale, 1=Strongly disagree to 5=Strongly agree). The questionnaire was composed by nine items distributed across three dimensions: * Knowledge and understanding: Items PPLI-PT4, PPLI-PT5, PPLI-PT17; * Self-perception and self-confidence: Items PPLI-PT2, PPLI-PT7, PPLI-PT8; * Self-expression and communication with others: Items PPLI-PT11, PPLI-PT12, PPLI-PT13. Scoring and Interpretation: For each dimension, add the responses to the corresponding items, divide the total by the number of items in the dimension (3) to obtain the average and record the scores for each dimension separately. Higher scores in each dimension reflect a greater perceived physical literacy in the respective specific area.

  Baseline, 6 months.

• EQ5D-5L

  An instrument to describe and value health across a wide range of disease areas. 5-level EQ-5D (EuroQol instrument with 5 dimensions and 5 levels) version with five dimensions (five levels, categorical options): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Score ranges: 1. I have no problems ...walking/dressing, etc (better outcome); 2. I have some problems ...walking/dressing, etc; 3. I have moderate problems ...walking/dressing, etc; 4. I have severe problems ...walking/dressing, etc; 5. I have extreme problems ...walking/dressing, etc (worse outcome).

  Baseline, 6 months

• Physical Activity Levels

  Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ - Short Version, 4 topics with 2 questions each one - question 1a, question 1b, question 2a, question 2b, etc). Score based on the formula: MET-min/week = MET × minutes per day × days per week (values for minutes and days per week are answered through questions 1a, 1b, 2a, 2b, 3a, 3b, 4a, 4b) Standard MET values for each activity type: * Walking: 3.3 METs * Moderate activity: 4.0 METs * Vigorous activity: 8.0 METs

  Baseline, 6 months

• Clinical and Metabolic Health Parameters - Total cholesterol

  Total cholesterol (mg/dl)

  Baseline, 6 months

• Clinical and Metabolic Health Parameters - HDL cholesterol

  HDL cholesterol (mg/dl - milligrams per deciliter)

  Baseline, 6 months.

• Clinical and Metabolic Health Parameters - LDL cholesterol

  HDL cholesterol (mg/dl - milligrams per deciliter) -- calculated field: LDL Cholesterol = Total Cholesterol - HDL Cholesterol - (Triglycerides / 5)

  Baseline, 6 months

• Clinical and Metabolic Health Parameters - nHDL cholesterol

  non-HDL cholesterol (mg/dl - milligrams per deciliter) -- calculated field: nHDL = Colesterol Total - Colesterol HDL

  Baseline, 6 months.

• Clinical and Metabolic Health Parameters - Triglycerides

  Triglycerides (mg/dl - milligrams per deciliter)

  Baseline, 6 months.

• Clinical and Metabolic Health Parameters - Fasting Glucose

  Fasting Glucose (mg/dl - milligrams per deciliter)

  Baseline, 6 months.

• Clinical and Metabolic Health Parameters - Glycated Hemoglobin

  Glycated Hemoglobin (%)

  Baseline, 6 months.

• Clinical and Metabolic Health Parameters - Aspartate Aminotransferase

  Aspartate Aminotransferase (U/L - units per liter)

  Baseline, 6 months.

• Clinical and Metabolic Health Parameters - Alanine Aminotransferase

  Alanine Aminotransferase (U/L - units per liter)

  Baseline, 6 months.

• Anthropometric Data - Body Mass Index (BMI)

  BMI-Body Mass Index (kg/m² - kilograms per square meter)

  Baseline, 6 months.

• Anthropometric Data - Abdominal circumference

  Abdominal circumference (cm)

  Baseline, 6 months.

• Anthropometric Data - Waist-to-height ratio

  Waist-to-height ratio (WHtR, cm-centimeter) WHtR = Waist Circumference (cm-centimeter) ÷ Height (cm-centimeter)

  Baseline, 6 months.

• Anthropometric Data - Blood pressure

  Blood pressure (mm Hg-millimeters of mercury)

  Baseline, 6 months.

• Anthropometric Data - Heart rate

  Heart rate (beat per minute)

  Baseline, 6 months.

Secondary Outcomes (14)

• App Usage Metrics - Daily Active Users

  6 months.

• App Usage Metrics - Monthly Active Users

  6 months.

• App Usage Metrics - Session Frequency

  6 months.

• App Usage Metrics - Session Duration

  6 months.

• Push Notification Engagement - Open Rate (%)

  6 months.

Study Arms (2)

Usual Care Without Digital Monitoring

NO INTERVENTION

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.

Mobile Application and Wearable Device for Physical Activity Monitoring

EXPERIMENTAL

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.

Device: Mobile Application and Wearable Device for Physical Activity Monitoring

Interventions

Mobile Application and Wearable Device for Physical Activity Monitoring 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.

Also known as: Fitbit Inspire 3, Mobile Health Application for Physical Activity Monitoring, Digital Health Intervention for Metabolic Syndrome, Polis Saúde App

Mobile Application and Wearable Device for Physical Activity Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andreia Lobo: lead
• University of Beira Interior: collaborator
• Centro Hospitalar Universitário de Coimbra: collaborator

Study Sites (1)

USF Cruz de Celas

Coimbra, Portugal, 3000-011, Portugal

Location

MeSH Terms

Conditions

Metabolic Syndrome; Motor Activity; Health Behavior; Patient Participation

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Andreia Filipa Lobo, Master

  Unidade Local de Saude de Coimbra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Primary-care Physician, Principal Investigator

Model Details: This is a two-arm, parallel-group, superiority randomized controlled trial designed to evaluate the influence of a mobile application for physical activity tracking on exercise behavior and clinical outcomes in individuals with metabolic syndrome managed in primary care. Participants will be randomly assigned in a 1:1 ratio to either an intervention group (mobile app + wearable device) or a control group (usual care).

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 19, 2025
• Study Start: July 24, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)