Metabolic SyndromeNCT05830552
The Effect of Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome in Aged 60 or Older
A study testing Receving feedback and No regular feedback in people with Metabolic Syndrome and Physical Activity, run by Pusan National University Hospital at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Physical Activity, Wearable Device
- What is being tested?
- Receving feedback and No regular feedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Metabolic Syndrome, Physical Activity, Wearable Device
- Being tested
- Receving feedback, No regular feedback
- Medical subject headings
- Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receving feedbackOther
Receving regular feedback from a health provider
No regular feedbackOther
No regular feedback from a health provider
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No regular feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: For 12 weeks
Secondary outcomes (6)
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).
Measured: Baseline and 12th week
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).
Measured: Baseline and 12th week
Changes in body composition at baseline and 12th week visits
Body composition was measured by bioelectrical impedance analysis (Inbody 720, Biospace Co Ltd, Seoul)
Measured: Baseline and 12th week
Depression index at baseline and 12th week visits
All participants completed the Beck Depression Inventory (BDI) questionnaires.
Measured: Baseline and 12th week
Stress scale questionnaires at baseline and 12th week visits
All participants completed the Perceived Stress Scale (PSS) questionnaires.
Measured: Baseline and 12th week
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).
Measured: Baseline and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Nov 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Jin Tak, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830552
- Sponsor's protocol ID
- PNUHH-2109-021-107
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05830552
- Acronym / sponsor ID
- PNUHH-2109-021-107
- Conditions
- Metabolic Syndrome, Physical Activity, Wearable Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Receving feedbackIn 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. |
| Control Group | Placebo comparator | Other: No regular feedbackIn the case of the control group, physical activity is monitored by itself through wearable devices and smartphone apps without phone counseling. |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receving feedbackReceving regular feedback from a health provider | Other | Intervention Group |
| No regular feedbackNo regular feedback from a health provider | Other | Control Group |
Primary outcome
Changes in fasting blood tests at baseline and 12th week visits
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.
Changes in blood pressure (systolic blood pressure, diastolic blood pressure) at baseline and 12th week visits
Time frame: Baseline and 12th week
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
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.
Measurement of physical activity through wearable devices
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.
6 secondary outcomes
Changes in body weight at baseline and 12th week visits
Time frame: Baseline and 12th week
Changes in height at baseline and 12th week visits
Time frame: Baseline and 12th week
Changes in body composition at baseline and 12th week visits
Time frame: Baseline and 12th week
Depression index at baseline and 12th week visits
Time frame: Baseline and 12th week
Stress scale questionnaires at baseline and 12th week visits
Time frame: Baseline and 12th week
Pulse wave velocity measurement on baseline and 12th week visits
Time frame: Baseline and 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receving feedback and No regular feedback in people with Metabolic Syndrome and Physical Activity, run by Pusan National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fasting blood tests at baseline and 12th week visits (time frame: Baseline and 12th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.