Back to resultsThe Effect of Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome in Aged 60 or Older
Primary Purpose
Metabolic Syndrome, Physical Activity, Wearable Device
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Receving feedback
No regular feedback
Sponsored by
About this trial
This is an interventional health services research trial for Metabolic Syndrome
Eligibility Criteria
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.
Sites / Locations
- Pusan National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention Group
Control Group
Arm Description
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.
In the case of the control group, physical activity is monitored by itself through wearable devices and smartphone apps without phone counseling.
Outcomes
Primary Outcome Measures
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.
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).
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.
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.
Secondary Outcome Measures
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).
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).
Changes in body composition at baseline and 12th week visits
Body composition was measured by bioelectrical impedance analysis (Inbody 720, Biospace Co Ltd, Seoul)
Depression index at baseline and 12th week visits
All participants completed the Beck Depression Inventory (BDI) questionnaires.
Stress scale questionnaires at baseline and 12th week visits
All participants completed the Perceived Stress Scale (PSS) questionnaires.
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).
Full Information
NCT ID
NCT05830552
First Posted
March 21, 2023
Last Updated
April 24, 2023
Sponsor
Pusan National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05830552
Brief Title
The Effect of Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome in Aged 60 or Older
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Physical Activity, Wearable Device
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
In the case of the control group, physical activity is monitored by itself through wearable devices and smartphone apps without phone counseling.
Intervention Type
Other
Intervention Name(s)
Receving feedback
Intervention Description
Receving regular feedback from a health provider
Intervention Type
Other
Intervention Name(s)
No regular feedback
Intervention Description
No regular feedback from a health provider
Primary Outcome Measure Information:
Title
Changes in fasting blood tests at baseline and 12th week visits
Description
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
Title
Changes in blood pressure (systolic blood pressure, diastolic blood pressure) at baseline and 12th week visits
Description
Blood pressure was measured in a sitting position after resting using BP-203 RVII(Colin Corp, Aichi, Japan).
Time Frame
Baseline and 12th week
Title
Changes in waist circumference (cm) at baseline and 12th week visits
Description
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
Title
Measurement of physical activity through wearable devices
Description
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 Outcome Measure Information:
Title
Changes in body weight at baseline and 12th week visits
Description
Body weight in kilograms were measured using a digital scale and stadiometer (BSM370, Biospace Co Ltd, Seoul).
Time Frame
Baseline and 12th week
Title
Changes in height at baseline and 12th week visits
Description
Height in meters were measured using a digital scale and stadiometer (BSM370, Biospace Co Ltd, Seoul).
Time Frame
Baseline and 12th week
Title
Changes in body composition at baseline and 12th week visits
Description
Body composition was measured by bioelectrical impedance analysis (Inbody 720, Biospace Co Ltd, Seoul)
Time Frame
Baseline and 12th week
Title
Depression index at baseline and 12th week visits
Description
All participants completed the Beck Depression Inventory (BDI) questionnaires.
Time Frame
Baseline and 12th week
Title
Stress scale questionnaires at baseline and 12th week visits
Description
All participants completed the Perceived Stress Scale (PSS) questionnaires.
Time Frame
Baseline and 12th week
Title
Pulse wave velocity measurement on baseline and 12th week visits
Description
Pulse wave velocity was measured in a comfortable supine position using the VP-1000 plus (Omron Healthcare, Bannockburn, IL).
Time Frame
Baseline and 12th week
Other Pre-specified Outcome Measures:
Title
Gathering subject information from the survey
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Pusan National University Hospital
City
Busan
State/Province
Seo-gu
ZIP/Postal Code
49241
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome in Aged 60 or Older
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