Use of a Mobile Application for Tracking Physical Activity in the Management of Metabolic Syndrom… (NCT07236450) | Clinical Trial Compass
CompletedNot Applicable
Use of a Mobile Application for Tracking Physical Activity in the Management of Metabolic Syndrome in Primary Care
Portugal100 participantsStarted 2025-07-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Physical Literacy
Timeframe: Baseline, 6 months.
2
EQ5D-5L
Timeframe: Baseline, 6 months
3
Physical Activity Levels
Timeframe: Baseline, 6 months
4
Clinical and Metabolic Health Parameters - Total cholesterol
Timeframe: Baseline, 6 months
5
Clinical and Metabolic Health Parameters - HDL cholesterol
Timeframe: Baseline, 6 months.
6
Clinical and Metabolic Health Parameters - LDL cholesterol
Timeframe: Baseline, 6 months
7
Clinical and Metabolic Health Parameters - nHDL cholesterol
Timeframe: Baseline, 6 months.
8
Clinical and Metabolic Health Parameters - Triglycerides