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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05630456
• Other study ID #: PNUHH-1904-022-078
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: November 2022
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 99 Years

Eligibility

Inclusion Criteria:

• smart phone user

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Metabolic Syndrome
• Physical Activity
• Syndrome

Intervention

Other:
• Receving feedback
Receving regular feedback from a health provider
• No regular feedback
No regular feedback from a health provider

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan	Seo-gu

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gathering subject information from the survey	All participants received information on demographics, occupation (usually for estimating physical activity intensity), frequency and duration of physical activity, history (diagnosis or drug treatment of hypertension, diabetes or dyslipidemia), health-related habits (smoking, drinking and alcohol), and medications taken through the survey. Participants were defined as non-smokers, past smokers, and current smokers, and non-smokers (0 to 98 g/week) or drinkers who drink an average of 7 cups of men and 5 or more cups of women twice per person.	Baseline
Other	Satisfaction of using wearable-smartphone apps using visual analog scale (VAS)	Investigators investigated the satisfaction of using wearable-smartphone apps using visual analog scale (VAS) (0; very dissatisfied, 10; very satisfied).	At 12th week
Primary	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
Primary	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
Primary	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
Primary	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	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