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Completed

NCT Number: NCT05630456

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

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

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Key information

Conditions

Metabolic Syndrome Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Physical Activity

Age range

19 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Hospital

Busan, Seo-gu, 49241, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • smart phone user

Exclusion criteria

-

Treatment and study plan

Receving feedback

Other

Receving regular feedback from a health provider

No regular feedback

Other

No regular feedback from a health provider

Primary outcomes

  1. 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)

  2. 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)

  3. 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.

  4. 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

  1. Changes in body composition at baseline and 12 weeks

    Time frame: Baseline 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)

Other outcomes

  1. Gathering subject information from the survey

    Time frame: Baseline

    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.

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

    Time frame: At 12th week

    Investigators investigated the satisfaction of using wearable-smartphone apps using visual analog scale (VAS) (0; very dissatisfied, 10; very satisfied).

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 29, 2022
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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