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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034338
Receipt No. R000039147
Scientific Title Investigation of the effect of the lifestyle intervention
Date of disclosure of the study information 2018/10/01
Last modified on 2019/10/28

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Basic information
Public title Investigation of the effect of the lifestyle intervention
Acronym Investigation of the effect of the lifestyle intervention
Scientific Title Investigation of the effect of the lifestyle intervention
Scientific Title:Acronym Investigation of the effect of the lifestyle intervention
Region
Japan

Condition
Condition Men and woman
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify effective methods of lifestyle intervention for each individual
Basic objectives2 Others
Basic objectives -Others Research
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Waist measurement and body weight before and after the lifestyle intervention
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Lifestyle intervention program
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
35 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria (1) Males and females aged 35 to 65 years old.
(2) Subjects whose either BMI is equal to or higher than 25, or waist measurement is equal to or greater than 85 cm(male)/ 90 cm(female).
(3) Subjects who permit research organization to receive their results of a medical examination from Health Insurance Association which they belong to.
(4) Subjects who show understanding of the study procedures and agreement with participating the study.
Key exclusion criteria (1) Subjects who have current medical history of severe disease which require a frequent doctor's visit or hospital stay.
(2) Subjects who possibly participate to other clinical trial.
(3) Subjects who have obvious difficulty to follow the direction of lifestyle intervention.
(4) Subjects who have been determined ineligible by principal investigator.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Shinji
Middle name
Last name Fukuda
Organization Metabologenomics, Inc.
Division name Headquarters
Zip code 997-0052
Address 246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL +81-235-64-0330
Email research@metagen.co.jp

Public contact
Name of contact person
1st name Shinnosuke
Middle name
Last name Murakami
Organization Metabologenomics, Inc.
Division name Headquarters
Zip code 997-0052
Address 246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL +81-235-64-0330
Homepage URL
Email research@metagen.co.jp

Sponsor
Institute Metabologenomics, Inc.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Sompo Health Support Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiyoda Paramedical Care Clinic
Address 3-3-5 Uchikanda, Chiyoda-ku, Tokyo
Tel 03-5297-5548
Email IRB@cpcc.co.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
2018 Year 10 Month 01 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
2018 Year 09 Month 20 Day
Date of IRB
2018 Year 09 Month 20 Day
Anticipated trial start date
2018 Year 10 Month 02 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 01 Day
Last modified on
2019 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039147

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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