Pusan National University Hospital
Busan, Seo-gu, 49241, South Korea
NCT Number: NCT05830552
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
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Notify Me60 year–99 year
All sexes
Interventional
Not applicable
Busan, Seo-gu, 49241, South Korea
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receving regular feedback from a health provider
No regular feedback from a health provider
Time frame: Baseline and 12th week
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
Blood pressure was measured in a sitting position after resting using BP-203 RVII(Colin Corp, Aichi, Japan).
Time frame: Baseline and 12th week
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: For 12 weeks
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: Baseline and 12th week
Body weight in kilograms were measured using a digital scale and stadiometer (BSM370, Biospace Co Ltd, Seoul).
Time frame: Baseline and 12th week
Height in meters were measured using a digital scale and stadiometer (BSM370, Biospace Co Ltd, Seoul).
Time frame: Baseline and 12th week
Body composition was measured by bioelectrical impedance analysis (Inbody 720, Biospace Co Ltd, Seoul)
Time frame: Baseline and 12th week
All participants completed the Beck Depression Inventory (BDI) questionnaires.
Time frame: Baseline and 12th week
All participants completed the Perceived Stress Scale (PSS) questionnaires.
Time frame: Baseline and 12th week
Pulse wave velocity was measured in a comfortable supine position using the VP-1000 plus (Omron Healthcare, Bannockburn, IL).
Time frame: Baseline
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.
Pusan National University Hospital
Other
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
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