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Metabolic Syndrome (MetS)IMAFILNCT07236450

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

A study testing Mobile Application and Wearable Device for Physical Activity Monitoring in people with Metabolic Syndrome (MetS), run by Andreia Lobo at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metabolic Syndrome (MetS)
What is being tested?
Mobile Application and Wearable Device for Physical Activity Monitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 sitePortugal
Study dates
24 Jul 2025to 1 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • USF Cruz de Celas

    Coimbra, Portugal, 3000-011

Other trials in Portugal

About this study

Official title: Exploring the Role of a Mobile Application for Physical Activity Tracking 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.

Read more

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.

Read the 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.

Being tested
Mobile Application and Wearable Device for Physical Activity Monitoring
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
Medical subject headings
Metabolic Syndrome, Motor Activity, Health Behavior, Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile Application and Wearable Device for Physical Activity MonitoringDevice

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

    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.

Study groups in NCT07236450
Study groupRoleWhat they receive
Usual Care Without Digital MonitoringNo interventionParticipants 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 MonitoringExperimentalParticipants 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.
Receives: Device: Mobile Application and Wearable Device for Physical Activity Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 6 months.

  2. 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).

    Measured: Baseline, 6 months

  3. 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

    Measured: Baseline, 6 months

  4. Clinical and Metabolic Health Parameters - Total cholesterol

    Total cholesterol (mg/dl)

    Measured: Baseline, 6 months

  5. Clinical and Metabolic Health Parameters - HDL cholesterol

    HDL cholesterol (mg/dl - milligrams per deciliter)

    Measured: Baseline, 6 months.

  6. Clinical and Metabolic Health Parameters - LDL cholesterol

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

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

    Measured: Baseline, 6 months

  7. Clinical and Metabolic Health Parameters - nHDL cholesterol

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

    Measured: Baseline, 6 months.

  8. Clinical and Metabolic Health Parameters - Triglycerides

    Triglycerides (mg/dl - milligrams per deciliter)

    Measured: Baseline, 6 months.

  9. Clinical and Metabolic Health Parameters - Fasting Glucose

    Fasting Glucose (mg/dl - milligrams per deciliter)

    Measured: Baseline, 6 months.

  10. Clinical and Metabolic Health Parameters - Glycated Hemoglobin

    Glycated Hemoglobin (%)

    Measured: Baseline, 6 months.

  11. Clinical and Metabolic Health Parameters - Aspartate Aminotransferase

    Aspartate Aminotransferase (U/L - units per liter)

    Measured: Baseline, 6 months.

  12. Clinical and Metabolic Health Parameters - Alanine Aminotransferase

    Alanine Aminotransferase (U/L - units per liter)

    Measured: Baseline, 6 months.

  13. Anthropometric Data - Body Mass Index (BMI)

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

    Measured: Baseline, 6 months.

  14. Anthropometric Data - Abdominal circumference

    Abdominal circumference (cm)

    Measured: Baseline, 6 months.

  15. Anthropometric Data - Waist-to-height ratio

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

    Measured: Baseline, 6 months.

  16. Anthropometric Data - Blood pressure

    Blood pressure (mm Hg-millimeters of mercury)

    Measured: Baseline, 6 months.

  17. Anthropometric Data - Heart rate

    Heart rate (beat per minute)

    Measured: Baseline, 6 months.

Secondary outcomes (14)

  1. App Usage Metrics - Daily Active Users

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

    Measured: 6 months.

  2. App Usage Metrics - Monthly Active Users

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

    Measured: 6 months.

  3. App Usage Metrics - Session Frequency

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

    Measured: 6 months.

  4. App Usage Metrics - Session Duration

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

    Measured: 6 months.

  5. Push Notification Engagement - Open Rate (%)

    Percentage of push notifications opened.

    Measured: 6 months.

  6. Push Notification Engagement - Dismissal Rate (%)

    Percentage of notifications ignored or dismissed.

    Measured: 6 months.

  7. Wearable activity tracker - measure 1

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

    Measured: 6 months

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

    Percentage of users who open motivational messages.

    Measured: 6 months.

  9. Motivational Content Interaction - Completion Rate (%)

    Percentage of users who fully read the messages.

    Measured: 6 months

  10. Motivational Content Interaction - Feedback Responses

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

    Measured: 6 months

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

    Change in the average daily step count over time.

    Measured: 6 months.

  12. Retention Rate by Users (%)

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

    Measured: 6 months.

  13. Streak Tracking

    Number of consecutive days comprising interaction with the app.

    Measured: 6 months

  14. Dropout rate (%)

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2025
  2. Study start24 Jul 2025
  3. Primary completion1 Feb 2026
  4. Study completion1 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07236450
Sponsor's protocol ID
EECC-2024_4-220 e 335/25 CE
Acronym
IMAFIL
Status last verified
Jan 2026
First submitted
15 Nov 2025
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mobile Application and Wearable Device for Physical Activity Monitoring in people with Metabolic Syndrome (MetS), run by Andreia Lobo at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical Literacy (time frame: Baseline, 6 months.). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07236450.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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