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Completed

NCT Number: NCT07236450

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

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.

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Key information

Conditions

Metabolic Syndrome (MetS) Behavior Glucose Metabolism Disorders Health Behavior Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Motor Activity Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Participation Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USF Cruz de Celas

Coimbra, Portugal, 3000-011

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Fitbit Inspire 3, Mobile Health Application for Physical Activity Monitoring, Digital Health Intervention for Metabolic Syndrome, Polis Saúde App

Primary outcomes

  1. Physical Literacy

    Time frame: Baseline, 6 months.

    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.

  2. EQ5D-5L

    Time frame: Baseline, 6 months

    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:

    • I have no problems ...walking/dressing, etc (better outcome);
    • I have some problems ...walking/dressing, etc;
    • I have moderate problems ...walking/dressing, etc;
    • I have severe problems ...walking/dressing, etc;
    • I have extreme problems ...walking/dressing, etc (worse outcome).

  3. Physical Activity Levels

    Time frame: Baseline, 6 months

    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

  4. Clinical and Metabolic Health Parameters - Total cholesterol

    Time frame: Baseline, 6 months

    Total cholesterol (mg/dl)

  5. Clinical and Metabolic Health Parameters - HDL cholesterol

    Time frame: Baseline, 6 months.

    HDL cholesterol (mg/dl - milligrams per deciliter)

  6. Clinical and Metabolic Health Parameters - LDL cholesterol

    Time frame: Baseline, 6 months

    HDL cholesterol (mg/dl - milligrams per deciliter) -- calculated field:

    LDL Cholesterol = Total Cholesterol - HDL Cholesterol - (Triglycerides / 5)

  7. Clinical and Metabolic Health Parameters - nHDL cholesterol

    Time frame: Baseline, 6 months.

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

  8. Clinical and Metabolic Health Parameters - Triglycerides

    Time frame: Baseline, 6 months.

    Triglycerides (mg/dl - milligrams per deciliter)

  9. Clinical and Metabolic Health Parameters - Fasting Glucose

    Time frame: Baseline, 6 months.

    Fasting Glucose (mg/dl - milligrams per deciliter)

  10. Clinical and Metabolic Health Parameters - Glycated Hemoglobin

    Time frame: Baseline, 6 months.

    Glycated Hemoglobin (%)

  11. Clinical and Metabolic Health Parameters - Aspartate Aminotransferase

    Time frame: Baseline, 6 months.

    Aspartate Aminotransferase (U/L - units per liter)

  12. Clinical and Metabolic Health Parameters - Alanine Aminotransferase

    Time frame: Baseline, 6 months.

    Alanine Aminotransferase (U/L - units per liter)

  13. Anthropometric Data - Body Mass Index (BMI)

    Time frame: Baseline, 6 months.

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

  14. Anthropometric Data - Abdominal circumference

    Time frame: Baseline, 6 months.

    Abdominal circumference (cm)

  15. Anthropometric Data - Waist-to-height ratio

    Time frame: Baseline, 6 months.

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

  16. Anthropometric Data - Blood pressure

    Time frame: Baseline, 6 months.

    Blood pressure (mm Hg-millimeters of mercury)

  17. Anthropometric Data - Heart rate

    Time frame: Baseline, 6 months.

    Heart rate (beat per minute)

Secondary outcomes

  1. App Usage Metrics - Daily Active Users

    Time frame: 6 months.

    Number of users engaging with the app daily (integer).

  2. App Usage Metrics - Monthly Active Users

    Time frame: 6 months.

    Number of users engaging with the app at least once per month (integer).

  3. App Usage Metrics - Session Frequency

    Time frame: 6 months.

    How often users open the app per day or week (number/day or /week).

  4. App Usage Metrics - Session Duration

    Time frame: 6 months.

    Average time spent in the app per session (minutes).

  5. Push Notification Engagement - Open Rate (%)

    Time frame: 6 months.

    Percentage of push notifications opened.

  6. Push Notification Engagement - Dismissal Rate (%)

    Time frame: 6 months.

    Percentage of notifications ignored or dismissed.

  7. Wearable activity tracker - measure 1

    Time frame: 6 months

    Data from the wearable activity tracker (e.g., step count and app usage patterns) - DESCREVER EXATAMENTE QUAIS SÃO AS MEDIÇÕES ANALISADAS

  8. Motivational Content Interaction - Message Open Rate (%)

    Time frame: 6 months.

    Percentage of users who open motivational messages.

  9. Motivational Content Interaction - Completion Rate (%)

    Time frame: 6 months

    Percentage of users who fully read the messages.

  10. Motivational Content Interaction - Feedback Responses

    Time frame: 6 months

    Number of "thumbs up" or "thumbs down" clicks on messages, reflecting their perceived usefulness

  11. Physical Activity Metrics - Step Count Increase (%)

    Time frame: 6 months.

    Change in the average daily step count over time.

  12. Retention Rate by Users (%)

    Time frame: 6 months.

    Percentage of users returning to the app after 1 week, 1 month, etc.

  13. Streak Tracking

    Time frame: 6 months

    Number of consecutive days comprising interaction with the app.

  14. Dropout rate (%)

    Time frame: 6 months

    Participants will be classified as dropouts if they have not used the mobile application and wearable device for a continuous period of 60 days.

Sponsors and collaborators

Lead sponsor

Andreia Lobo

Other

Collaborators

  • Centro Hospitalar Universitário de Coimbra
  • University of Beira Interior

Registry information

Official study title

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

Acronym: IMAFIL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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