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

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

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

Study Overview

• Status: Completed
• Conditions: Physical Activity; Metabolic Syndrome; Wearable Device
• Intervention / Treatment: Other: Receving feedback; Other: No regular feedback

Detailed Description

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
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seo-gu
    • Busan, Seo-gu, Korea, Republic of, 49241
      • Pusan National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; 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; No regular feedback from a health provider
Experimental: 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 encouraged continuous data transmission.	Other: Receving feedback; Receving regular feedback from a health provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	For 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	Baseline and 12th week
Changes in body composition at baseline and 12th week visits	Body composition was measured by bioelectrical impedance analysis (Inbody 720, Biospace Co Ltd, Seoul)	Baseline and 12th week
Depression index at baseline and 12th week visits	All participants completed the Beck Depression Inventory (BDI) questionnaires.	Baseline and 12th week
Stress scale questionnaires at baseline and 12th week visits	All participants completed the Perceived Stress Scale (PSS) questionnaires.	Baseline and 12th week
Pulse wave velocity measurement on baseline and 12th week visits	Pulse wave velocity was measured in a comfortable supine position using the VP-1000 plus (Omron Healthcare, Bannockburn, IL).	Baseline and 12th week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pusan National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: PNUHH-2109-021-107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No