Exploring the Role of a Mobile Application for Physical Activity Tracking in the Management of Metabolic Syndrome in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical and Metabolic Health Parameters - Glycated Hemoglobin
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: Mobile Application and Wearable Device for Physical Activity Monitoring (Device)
结局指标
主要结局
Clinical and Metabolic Health Parameters - Glycated Hemoglobin
时间窗: Baseline, 6 months.
Glycated Hemoglobin (%)
Physical Literacy
时间窗: 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.
EQ5D-5L
时间窗: 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: 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).
Physical Activity Levels
时间窗: 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
Clinical and Metabolic Health Parameters - Total cholesterol
时间窗: Baseline, 6 months
Total cholesterol (mg/dl)
Clinical and Metabolic Health Parameters - Fasting Glucose
时间窗: Baseline, 6 months.
Fasting Glucose (mg/dl - milligrams per deciliter)
Clinical and Metabolic Health Parameters - HDL cholesterol
时间窗: Baseline, 6 months.
HDL cholesterol (mg/dl - milligrams per deciliter)
Clinical and Metabolic Health Parameters - LDL cholesterol
时间窗: Baseline, 6 months
HDL cholesterol (mg/dl - milligrams per deciliter) -- calculated field: LDL Cholesterol = Total Cholesterol - HDL Cholesterol - (Triglycerides / 5)
Clinical and Metabolic Health Parameters - nHDL cholesterol
时间窗: Baseline, 6 months.
non-HDL cholesterol (mg/dl - milligrams per deciliter) -- calculated field: nHDL = Colesterol Total - Colesterol HDL
Clinical and Metabolic Health Parameters - Triglycerides
时间窗: Baseline, 6 months.
Triglycerides (mg/dl - milligrams per deciliter)
Clinical and Metabolic Health Parameters - Aspartate Aminotransferase
时间窗: Baseline, 6 months.
Aspartate Aminotransferase (U/L - units per liter)
Clinical and Metabolic Health Parameters - Alanine Aminotransferase
时间窗: Baseline, 6 months.
Alanine Aminotransferase (U/L - units per liter)
Anthropometric Data - Body Mass Index (BMI)
时间窗: Baseline, 6 months.
BMI-Body Mass Index (kg/m² - kilograms per square meter)
Anthropometric Data - Abdominal circumference
时间窗: Baseline, 6 months.
Abdominal circumference (cm)
Anthropometric Data - Waist-to-height ratio
时间窗: Baseline, 6 months.
Waist-to-height ratio (WHtR, cm-centimeter) WHtR = Waist Circumference (cm-centimeter) ÷ Height (cm-centimeter)
Anthropometric Data - Blood pressure
时间窗: Baseline, 6 months.
Blood pressure (mm Hg-millimeters of mercury)
Anthropometric Data - Heart rate
时间窗: Baseline, 6 months.
Heart rate (beat per minute)
次要结局
- App Usage Metrics - Monthly Active Users(6 months.)
- App Usage Metrics - Daily 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.)
- Push Notification Engagement - Dismissal Rate (%)(6 months.)
- Wearable activity tracker - measure 1(6 months)
- Motivational Content Interaction - Message Open Rate (%)(6 months.)
- Motivational Content Interaction - Completion Rate (%)(6 months)
- Motivational Content Interaction - Feedback Responses(6 months)
- Physical Activity Metrics - Step Count Increase (%)(6 months.)
- Retention Rate by Users (%)(6 months.)
- Streak Tracking(6 months)
- Dropout rate (%)(6 months)
研究者
Andreia Lobo
MD, Primary-care Physician, Principal Investigator
Unidade Local de Saúde de Coimbra, EPE