Clinical trial NCT05830552: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Physical Activity
Wearable Device
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Changes in fasting blood tests at baseline and 12th week visits
timeFrame: Baseline and 12th week
measure: Changes in blood pressure (systolic blood pressure, diastolic blood pressure) at baseline and 12th week visits
timeFrame: Baseline and 12th week
measure: Changes in waist circumference (cm) at baseline and 12th week visits
timeFrame: Baseline and 12th week
measure: Measurement of physical activity through wearable devices
timeFrame: For 12 weeks
Secondary outcomes:
measure: Changes in body weight at baseline and 12th week visits
timeFrame: Baseline and 12th week
measure: Changes in height at baseline and 12th week visits
timeFrame: Baseline and 12th week
measure: Changes in body composition at baseline and 12th week visits
timeFrame: Baseline and 12th week
measure: Depression index at baseline and 12th week visits
timeFrame: Baseline and 12th week
measure: Stress scale questionnaires at baseline and 12th week visits
timeFrame: Baseline and 12th week
measure: Pulse wave velocity measurement on baseline and 12th week visits
timeFrame: Baseline and 12th week
Other outcomes:
measure: Gathering subject information from the survey
timeFrame: Baseline
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Seo-gu
Study officials:
References: