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

NCT ID: NCT05630456

Last Updated: 2022-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-01-31

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.

Conditions

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Metabolic Syndrome Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Receving feedback

Intervention Type OTHER

Receving regular feedback from a health provider

Control Group

In the case of the control group, physical activity is monitored by itself through wearable devices and smartphone apps without phone counseling.

Group Type PLACEBO_COMPARATOR

No regular feedback

Intervention Type OTHER

No regular feedback from a health provider

Interventions

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Receving feedback

Receving regular feedback from a health provider

Intervention Type OTHER

No regular feedback

No regular feedback from a health provider

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* smart phone user

Exclusion Criteria

\-
Minimum Eligible Age

19 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pusan National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Jin Tak

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pusan National University Hospital

Busan, Seo-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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PNUHH-1904-022-078

Identifier Type: -

Identifier Source: org_study_id

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