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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- Fasting blood tests on baseline and 12th week visits
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •smart phone user
Exclusion Criteria
- Not provided
Arms & Interventions
Control Group
In the case of the control group, physical activity is monitored by itself through wearable devices and smartphone apps without phone counseling.
Intervention: No regular feedback (Other)
Intervention Group
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.
Intervention: Receving feedback (Other)
Outcomes
Primary Outcomes
Fasting blood tests on baseline and 12th week visits
Time Frame: Baseline and 12week
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)
Changes in blood pressure (systolic blood pressure, diastolic blood pressure) at baseline and 12 weeks
Time Frame: Baseline and 12week
Blood pressure was measured in a sitting position after resting using BP-203 RVII(Colin Corp, Aichi, Japan)
Changes in waist circumference (cm) at baseline and 12 weeks
Time Frame: Baseline and 12week
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.
Measurement of physical activity through wearable devices
Time Frame: For 12 weeks
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.
Secondary Outcomes
- Changes in body composition at baseline and 12 weeks(Baseline and 12week)
Investigators
Young Jin Tak
Principal Investigator
Pusan National University Hospital