UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034338 |
|---|---|
| Receipt number | R000039147 |
| Scientific Title | Investigation of the effect of the lifestyle intervention |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2022/10/05 11:17:19 |
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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
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
research@metagen.co.jp
Sponsor or person
Institute
Metabologenomics, Inc.
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039147
