UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on the effectiveness of health promotion tourism program for life style related diseases "Smart Life Stay"
Title of the study (Brief title)	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	Tomofumi Hayase
Organization	Aichi Health Promotion Public Interest Foundation
Division name	Secretariat
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	Tomofumi Hayase
Organization	Aichi Health Promotion Public Interest Foundation
Division name	Secretariat
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000021132