The Effect of Health Provider's Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome

Sponsor
Pusan National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05630456
Collaborator
(none)
67
1
2
6
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Study Details

Study Description

Brief Summary

The Effect of Health Provider's Feedback on Physical Activity Surveillance using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome; a 12-Week Randomized Control Study

Condition or Disease Intervention/Treatment Phase
  • Other: Receving feedback
  • Other: No regular feedback
N/A

Detailed Description

Patients diagnosed with metabolic syndrome were recruited and prescribed to live for 12 weeks using a wrist-wearable device (B.BAND, B Life Inc, Korea). The block randomization method was used to distribute the participants between an intervention group (n=35) and control group (n=32). In the intervention group, an experienced study coordinator provided feedback on physical activity to individuals through telephone counseling every other week.

Study Design

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
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.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 (Participant, Investigator)
Primary Purpose:
Health Services Research
Official Title:
The Effect of Health Provider's Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome; a 12-Week Randomized Control Study
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
Jan 31, 2021
Actual Study Completion Date :
Jan 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

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 apps, and encouraged continuous data transmission.

Other: Receving feedback
Receving regular feedback from a health provider

Placebo Comparator: Control Group

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

Other: No regular feedback
No regular feedback from a health provider

Outcome Measures

Primary Outcome Measures

  1. Fasting blood tests on baseline and 12th week visits [Baseline and 12week]

    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. FPG levels were evaluated using glucose oxidase methods and Synchron LX 20 (Beckman Coulter, Fullerton, CA)

  2. Changes in blood pressure (systolic blood pressure, diastolic blood pressure) at baseline and 12 weeks [Baseline and 12week]

    Blood pressure was measured in a sitting position after resting using BP-203 RVII(Colin Corp, Aichi, Japan)

  3. Changes in waist circumference (cm) at baseline and 12 weeks [Baseline and 12week]

    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.

  4. Measurement of physical activity through wearable devices [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. Subsequently, a compatible app was installed on the participants' mobile phones and connected to a wearable device. Researchers who have been granted access can check and track participants' steps, calorie consumption, and MVPA (moderate- to vigorousintensity physical activity) on a daily basis through a web page.

Secondary Outcome Measures

  1. Changes in body composition at baseline and 12 weeks [Baseline and 12week]

    Body weight in kilograms and height in meters were measured using a digital scale and stadiometer (BSM370, Biospace Co Ltd, Seoul), while the study subjects were dressed in light clothing without shoes. Body composition was measured by bioelectrical impedance analysis (Inbody 720, Biospace Co Ltd, Seoul)

Other Outcome Measures

  1. Gathering subject information from the survey [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.

  2. Satisfaction of using wearable-smartphone apps using visual analog scale (VAS) [At 12th week]

    Investigators investigated the satisfaction of using wearable-smartphone apps using visual analog scale (VAS) (0; very dissatisfied, 10; very satisfied).

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • smart phone user
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pusan National University Hospital Busan Seo-gu Korea, Republic of 49241

Sponsors and Collaborators

  • Pusan National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Young Jin Tak, Principal Investigator, Pusan National University Hospital
ClinicalTrials.gov Identifier:
NCT05630456
Other Study ID Numbers:
  • PNUHH-1904-022-078
First Posted:
Nov 29, 2022
Last Update Posted:
Nov 29, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2022