The Effect of Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome in Aged 60 or Older

Pusan National University Hospital40 enrolled

Overview

The Effect of Feedback on Physical Activity Surveillance using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome in Aged 60 or older; a 12-Week Randomized Control Study

Research on whether wearable device interventions can effectively prevent metabolic syndrome remains insufficient. This study aimed to evaluate the effect of feedback on clinical indicators in patients with metabolic syndrome aged 60 or older on activities measured using wearable devices, such as smartphone apps. Patients aged 60 or older diagnosed with metabolic syndrome were recruited and prescribed to survive for 12 weeks using wrist-worn devices (B.BAND, B Life Inc, Korea). The block randomization method was used to distribute the participants between an intervention group (n=20) and control group (n=20). In the intervention group, an experienced study coordinator provided feedback on physical activity to individuals through telephone counseling every other week.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

Conditions

Metabolic Syndrome Physical Activity Wearable Device

Interventions

Receving feedbackOTHER

Receving regular feedback from a health provider

No regular feedbackOTHER

No regular feedback from a health provider

Eligibility

Sex: ALLMin age: 60 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with metabolic syndrome by a doctor. * Aged 60 or older. * A person who understands the clinical trial process and signs the consent form * Possession of a smartphone and a daily mobile phone user for the past 3. months and expected to use for more than 3 months. * A person who agrees to provide the data on the amount of physical activity measured and collected by a wearable device. * A person who can exercise at an intensity more than walking for 12 weeks. Exclusion Criteria: * Under the aged 60. * A person who does not agree to provide data on physical activity. * Those who who are judged to have difficulty in exercising such as walking due to uncontrolled diabetes, high blood pressure or serious cardiovascular disease. * A person who is not used to or is reluctant to use a smartphone app. * Those who have difficulty wearing wearable devices due to skin diseases around their wrists. * A person who is expected to have an unintended change in weight over the next three months due to current pregnancy and planning, thyroid disease, cancer, etc.

Locations (1)

Pusan National University Hospital

Busan, Seo-gu, South Korea

Outcomes

Primary Outcomes

Changes in fasting blood tests at 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.

Time frame: Baseline and 12th week

Changes in blood pressure (systolic blood pressure, diastolic blood pressure) at baseline and 12th week visits

Blood pressure was measured in a sitting position after resting using BP-203 RVII(Colin Corp, Aichi, Japan).

Time frame: Baseline and 12th week

Changes in waist circumference (cm) at baseline and 12th week visits

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.

Time frame: Baseline and 12th week

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. Researchers who have been granted access can check and track participants' physical activity on a daily basis through a web page.

Time frame: For 12 weeks

Secondary Outcomes

Changes in body weight at baseline and 12th week visits

Body weight in kilograms were measured using a digital scale and stadiometer (BSM370, Biospace Co Ltd, Seoul).

Time frame: Baseline and 12th week

Changes in height at baseline and 12th week visits

Height in meters were measured using a digital scale and stadiometer (BSM370, Biospace Co Ltd, Seoul).

Data from ClinicalTrials.gov

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