Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-30 @ 12:46 PM
Study NCT ID:
NCT05630456
Status:
COMPLETED
Last Update Posted:
2022-11-29
First Post:
2022-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Health Provider's Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "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."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-27', 'studyFirstSubmitDate': '2022-10-24', 'studyFirstSubmitQcDate': '2022-11-27', 'lastUpdatePostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gathering subject information from the survey', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Satisfaction of using wearable-smartphone apps using visual analog scale (VAS)', 'timeFrame': 'At 12th week', 'description': 'Investigators investigated the satisfaction of using wearable-smartphone apps using visual analog scale (VAS) (0; very dissatisfied, 10; very satisfied).'}], 'primaryOutcomes': [{'measure': 'Fasting blood tests on baseline and 12th week visits', 'timeFrame': 'Baseline and 12week', 'description': "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)"}, {'measure': 'Changes in blood pressure (systolic blood pressure, diastolic blood pressure) at baseline and 12 weeks', 'timeFrame': 'Baseline and 12week', 'description': 'Blood pressure was measured in a sitting position after resting using BP-203 RVII(Colin Corp, Aichi, Japan)'}, {'measure': 'Changes in waist circumference (cm) at baseline and 12 weeks', 'timeFrame': 'Baseline and 12week', 'description': '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.'}, {'measure': 'Measurement of physical activity through wearable devices', 'timeFrame': 'For 12 weeks', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Changes in body composition at baseline and 12 weeks', 'timeFrame': 'Baseline and 12week', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome', 'Physical Activity']}, 'descriptionModule': {'briefSummary': "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", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* smart phone user\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05630456', 'briefTitle': "The Effect of Health Provider's Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome", 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Hospital'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'PNUHH-1904-022-078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention 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 apps, and encouraged continuous data transmission.", 'interventionNames': ['Other: Receving feedback']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'In the case of the control group, physical activity is monitored by itself through wearable devices and smartphone apps without phone counseling.', 'interventionNames': ['Other: No regular feedback']}], 'interventions': [{'name': 'Receving feedback', 'type': 'OTHER', 'description': 'Receving regular feedback from a health provider', 'armGroupLabels': ['Intervention Group']}, {'name': 'No regular feedback', 'type': 'OTHER', 'description': 'No regular feedback from a health provider', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49241', 'city': 'Busan', 'state': 'Seo-gu', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Young Jin Tak', 'investigatorAffiliation': 'Pusan National University Hospital'}}}}