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

NCT05630456 | Completed

• 1 other identifier: PNUHH-1904-022-078
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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

Conditions

Metabolic Syndrome; Physical Activity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Changes in body composition at baseline and 12 weeks

  Baseline and 12week

Other Outcomes (2)

• Gathering subject information from the survey

  Baseline

• Satisfaction of using wearable-smartphone apps using visual analog scale (VAS)

  At 12th week

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Interventions

Receving feedback OTHER

Receving regular feedback from a health provider

Intervention Group

No regular feedback OTHER

No regular feedback from a health provider

Control Group

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• smart phone user

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University Hospital

Busan, Seo-gu, 49241, South Korea

Location

MeSH Terms

Conditions

Metabolic Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 29, 2022
• Study Start: August 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

KR (1)