臨床研究等提出・公開システム

Scientific Title	Effect on health promotion by wearable device (FItbit-1)
Public Title	Effect on health promotion by wearable device

Contact for Scientific Queries	Investigator Name	Masayuki Tatemeichi
	Investigator Organization	Tokai University School of Medicine
	Address	143 Shimokasuya Isehara Kanagawa
	TEL	+81-463-93-1121
	E-mail	tatemichi@tokai-u.jp
Contact for Public Queries	Contact Name	Shujiro Yamada
	Contact Organization	Fuji filme Co. Ltd
	Address	9-7-5 Akasaka Minatoku Tokyo
	TEL	+81-3-6427-2609
	E-mail	shuichiro.yamada@fujifilm.com

Recruitment Status	COMPLETED

Date of First Enrollment		July. 01, 2017
Planned Number of Subjects		200
Nature of Investigation		Interventional
Study Design	Description of Trial Design	Parallel-Group Comparative Study
	Type of Control
	Trial Blinding Schema	open(masking not used)
	Randomized	Yes
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	BMI>23
	Exclusion Criteria	Mental disease Broad business trip for more than 1 month
	Minimum Age	25age old over
	Maximum Age	65age old under
	Sex of Participants	Both
Trial Indication(s)		metabolic syndrome
Intervention(s)		Intervention type:BEHAVIOUR Name of intervention:wearable device Dose form / Japanese Medical Device Nomenclature:OTHER Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention:3 months Intended dose regimen: detailes of teratment arms:excersise using wearable device Comparative intervention name:control Dose form / Japanese Medical Device Nomenclature:OTHER,OTHER Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention:3 months Intended dose regimen:
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		chage in body weight
Secondary Outcome(s)		change in behavior stage, liver function, triglyceride

Primary Sponsor	Fuji film Co. Ltd
Secondary Sponsor

Sources of funding	Fuji film Co. Ltd

Name of Ethics Committee	Clinical reseach review board of Tokai University
Address
TEL
FAX
E-Mail
Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved	Feb. 20, 2018

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Secondary Study ID	Nill Known
Issuer Name

Secondary Study ID	JMA-IIA00319
Issuer Name

Countrie(s) of Recruitment	Thailand

History of Changes

No	Publication date
2	Aug. 23, 2022	(this page)	Changes
1	Jan. 09, 2018	Detail

List of change history