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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030600
Receipt No. R000034948
Scientific Title Effects of mastification method on obesity
Date of disclosure of the study information 2017/12/28
Last modified on 2017/12/27

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Basic information
Public title Effects of mastification method on obesity
Acronym Effects of mastification method on obesity
Scientific Title Effects of mastification method on obesity
Scientific Title:Acronym Effects of mastification method on obesity
Region
Japan

Condition
Condition Obesity, MetS
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to investigate the effects of intensive health guidance focusing on eating quickly on obesity and metabolic syndrome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes obesity, MetS
Key secondary outcomes eating speed, blood data, health behaviors

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 health guidance focusing on eating quickly
Interventions/Control_2 standard health guidance about MetS
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
40 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria Mets
Key exclusion criteria written informed consent is not obtained, inappropriate participants
Target sample size 98

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Morita
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Departments of Preventive Dentistry
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 086-235-6712
Email mmorita@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Morita
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Departments of Preventive Dentistry
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 086-235-6712
Homepage URL
Email mmorita@md.okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2017 Year 12 Month 28 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
2008 Year 11 Month 24 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 27 Day
Last modified on
2017 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034948

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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