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

Pusan National University

Status: Completed

Conditions: Physical Activity; Wearable Device; Metabolic Syndrome

Treatments: Other: Receving feedback; Other: No regular feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT05830552

PNUHH-2109-021-107

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 60 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

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.

Treatment:

Other: Receving feedback

Control Group

Placebo Comparator group

Description:

In the case of the control group, physical activity is monitored by itself through wearable devices and smartphone apps without phone counseling.

Treatment:

Other: No regular feedback