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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

Not Applicable
Completed
Conditions
Metabolic Syndrome
Physical Activity
Interventions
Other: Receving feedback
Other: No regular feedback
Registration Number
NCT05630456
Lead Sponsor
Pusan National University Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
67
Inclusion Criteria
  • smart phone user
Exclusion Criteria

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Intervention GroupReceving feedbackIn 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.
Control GroupNo regular feedbackIn the case of the control group, physical activity is monitored by itself through wearable devices and smartphone apps without phone counseling.
Primary Outcome Measures
NameTimeMethod
Fasting blood tests on baseline and 12th week visitsBaseline 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 weeksBaseline 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 weeksBaseline 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 devicesFor 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 Outcome Measures
NameTimeMethod
Changes in body composition at baseline and 12 weeksBaseline and 12week

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)

Trial Locations

Locations (1)

Pusan National University Hospital

🇰🇷

Busan, Seo-gu, Korea, Republic of

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