UMIN-CTR Clinical Trial

Basic information
Public title	Observational study on behavior change through the use of personal health records (PHR) and health management apps
Acronym	Kanazawa-PHR Study
Scientific Title	Observational study on behavior change through the use of personal health records (PHR) and health management apps
Scientific Title:Acronym	Kanazawa-PHR Study
Region	Japan

Condition
Condition	Metabolic syndrome
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Intervene in the lives of people who meet the diagnostic criteria for metabolic syndrome using a personal health record and a health management application that utilizes IoT devices to evaluate changes in behavior change stages and health examination results data from health checkups.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of Behavior Change Stage
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	Use of health checkup results app Use of diet and health management apps
Interventions/Control_2	Use of health checkup results app
Interventions/Control_3	No use of apps
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Those who are determined to have metabolic syndrome or to be in the pre-metabolic syndrome group in the health checkup
Key exclusion criteria	1. those who do not have metabolic syndrome or are not in the pre-metabolic syndrome group 2. those on insulin self-injection management for diabetes mellitus 3. subjects who are deemed inappropriate as research subjects by the principal investigator or a research associate.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Yoneda
Organization	Kanazawa University Hospital
Division name	Internal medicine of Endocrinology and Metabolism
Zip code	920-8641
Address	Takara-machi 13-1, Kanazawa, Ishikawa
TEL	076-265-2778
Email	endocrin@med.kanazawa-u.ac.jp

Public contact
Name of contact person	1st name Mitsuhiro Middle name Last name Kometani
Organization	Kanazawa University Hospital
Division name	Internal medicine of Endocrinology and Metabolism
Zip code	920-8641
Address	Takara-machi 13-1, Kanazawa, Ishikawa
TEL	076-265-2778
Homepage URL
Email	mkome@med.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee, Kanazawa University
Address	Takara-machi 13-1, Kanazawa, Ishikawa
Tel	076-265-2100
Email	t-isomu@adm.kanazawa-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2021 Year 06 Month 29 Day
Date of IRB	2021 Year 06 Month 29 Day
Anticipated trial start date	2021 Year 06 Month 29 Day
Last follow-up date	2024 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 03 Month 29 Day
Last modified on	2022 Year 11 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053970