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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018257
Receipt No. R000021132
Scientific Title Research on the effectiveness of health promotion tourism program for life style related diseases "Smart Life Stay"
Date of disclosure of the study information 2015/07/10
Last modified on 2018/01/10

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Basic information
Public title Research on the effectiveness of health promotion tourism program for life style related diseases "Smart Life Stay"
Acronym Research on the effectiveness of health promotion tourism program for life style related diseases "Smart Life Stay"
Scientific Title Research on the effectiveness of health promotion tourism program for life style related diseases "Smart Life Stay"
Scientific Title:Acronym Research on the effectiveness of health promotion tourism program for life style related diseases "Smart Life Stay"
Region
Japan

Condition
Condition Diabetes Mellitus, Obesity, Metabolic Syndrome, pre-Metabolic Syndrome
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop health promotion tourism program for life style related diseases , and to explore the effects of the programs
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Completion rate, Variables regarding metabolic syndrome,
Self efficacy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Encourage to change life style by lectures and practice related to diet and exercise
Interventions/Control_2
Interventions/Control_3
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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Diabetes Mellitus, Impaired Glucose tolerance, Obesity, Metabolic Syndrome, pre-Metabolic Syndrome
Key exclusion criteria Current medication of myocardial infarction and apoplexy.
Severe hypertension (BP: higher than 180/100 mmHg).
Severe diabetic complications.
Poor control of plasma glucose (FPG: higher than 140mg/dl).
Current medication of mental disorders.
Alcohol use disorders.
Current medication of dementia.
Subjects prohibited from participating the program by medical doctors.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomofumi Hayase
Organization Aichi Health Promotion Public Interest Foundation
Division name Secretariat
Zip code
Address Gengoyama1-1, Morioka, Higashiura-cho, Chita-gun, Aichi, Japan
TEL 0562-82-0206
Email t-hayase@grp.ahv.pref.aichi.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomofumi Hayase
Organization Aichi Health Promotion Public Interest Foundation
Division name Secretariat
Zip code
Address Gengoyama1-1, Morioka, Higashiura-cho, Chita-gun, Aichi, Japan
TEL 0562-82-0206
Homepage URL
Email t-hayase@grp.ahv.pref.aichi.jp

Sponsor
Institute Aichi Health Promotion Public Interest Foundation
Institute
Department

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

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 07 Month 10 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 Completed
Date of protocol fixation
2015 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 11 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 05 Month 31 Day
Date trial data considered complete
2017 Year 07 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 07 Month 09 Day
Last modified on
2018 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021132

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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