The Effect of Health Provider's Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome

Study Overview
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Brief Summary
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The Effect of Health Provider's Feedback on Physical Activity Surveillance using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome; a 12-Week Randomized Control Study

Detailed Description
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Patients diagnosed with metabolic syndrome were recruited and prescribed to live for 12 weeks using a wrist-wearable device (B.BAND, B Life Inc, Korea). The block randomization method was used to distribute the participants between an intervention group (n=35) and control group (n=32). In the intervention group, an experienced study coordinator provided feedback on physical activity to individuals through telephone counseling every other week.

Official Title
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The Effect of Health Provider's Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome; a 12-Week Randomized Control Study

Conditions
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Metabolic Syndrome, Physical Activity

Intervention / Treatment
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* Other: Receving feedback
* Other: No regular feedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: smart phone user Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: In the intervention group, the researcher provided feedback on the participants' exercise amount through telephone contact every two weeks during the 12-week study period. It includes recommendations for continuing exercise therapy based on the recommendations for physical activity. Through phone consultations, they answered questions about exercise or discussed problems, were encouraged to continue exercising, answered questions or discussed problems related to wearable devices and apps, and encouraged for continuous data transmission.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>In the intervention group, the researcher gave feedback on the subjects' exercise amount through telephone contact every 2 weeks during the 12-week study period. Through phone consultations, they answered questions about exercise or discussed problems, encouraged to continue exercising, answered questions or discussed problems related to wearable devices and apps, and encouraged continuous data transmission. | Other: Receving feedback<br>* Receving regular feedback from a health provider<br>|
| Placebo Comparator: Control Group<br>In the case of the control group, physical activity is monitored by itself through wearable devices and smartphone apps without phone counseling. | Other: No regular feedback<br>* No regular feedback from a health provider<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood tests on baseline and 12th week visits | Blood samples were collected from the Jeonju vein after fasting for 6 hours and analyzed in our hospital's laboratory. The lipid profile was tested using an automated analyzer (Hitachi 747, Hitachi Corp, Japan) and enzyme colorimetric method. FPG levels were evaluated using glucose oxidase methods and Synchron LX 20 (Beckman Coulter, Fullerton, CA) | Baseline and 12week | 
| Changes in blood pressure (systolic blood pressure, diastolic blood pressure) at baseline and 12 weeks | Blood pressure was measured in a sitting position after resting using BP-203 RVII(Colin Corp, Aichi, Japan) | Baseline and 12week | 
| Changes in waist circumference (cm) at baseline and 12 weeks | The waist circumference was evaluated by a trained examiner (after normal exhalation) to the nearest millimeter from the midpoint between the lower edge of the rib and the iliac ridge. | Baseline and 12week | 
| Measurement of physical activity through wearable devices | Investigators provided with wrist-wearable device (B.BAND, B Life Inc, Korea), which allowed them to wear and live for 12 weeks. Subsequently, a compatible app was installed on the participants' mobile phones and connected to a wearable device. Researchers who have been granted access can check and track participants' steps, calorie consumption, and MVPA (moderate- to vigorousintensity physical activity) on a daily basis through a web page. | For 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body composition at baseline and 12 weeks | Body weight in kilograms and height in meters were measured using a digital scale and stadiometer (BSM370, Biospace Co Ltd, Seoul), while the study subjects were dressed in light clothing without shoes. Body composition was measured by bioelectrical impedance analysis (Inbody 720, Biospace Co Ltd, Seoul) | Baseline and 12week |