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

NCT05830552 | Completed

• 1 other identifier: PNUHH-2109-021-107
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Metabolic Syndrome; Physical Activity; Wearable Device

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Changes in body weight at baseline and 12th week visits

  Baseline and 12th week

• Changes in height at baseline and 12th week visits

  Baseline and 12th week

• Changes in body composition at baseline and 12th week visits

  Baseline and 12th week

• Depression index at baseline and 12th week visits

  Baseline and 12th week

• Stress scale questionnaires at baseline and 12th week visits

  Baseline and 12th week

Other Outcomes (1)

• Gathering subject information from the survey

  Baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Interventions

Receving feedback OTHER

Receving regular feedback from a health provider

Intervention Group

No regular feedback OTHER

No regular feedback from a health provider

Control Group

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University Hospital

Busan, Seo-gu, 49241, South Korea

Location

MeSH Terms

Conditions

Metabolic Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 26, 2023
• Study Start: November 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

KR (1)