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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05830552
• Other study ID #: PNUHH-2109-021-107
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2023
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Physical Activity
• Syndrome

Intervention

Other:
• Receving feedback
Receving regular feedback from a health provider
• No regular feedback
No regular feedback from a health provider

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan	Seo-gu

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Depression index at baseline and 12th week visits	All participants completed the Beck Depression Inventory (BDI) questionnaires.	Baseline and 12th week
Secondary	Stress scale questionnaires at baseline and 12th week visits	All participants completed the Perceived Stress Scale (PSS) questionnaires.	Baseline and 12th week
Secondary	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