UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of psychological and behavioral aspect of obese patients aim for weight reduction therapy by questionnaire
Title of the study (Brief title)	Assessment of obese patients by questionnaire
Region	Japan

Condition
Condition	Obesity
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess current condition of obesity and its treatment
Basic objectives2	Others
Basic objectives -Others	Start point and time-course changes of questionnaire score
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Relationship between each score of questionnaire and body weight/BMI/weight reduction ratio
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Patients with BMI above 25 kg/m2
Key exclusion criteria	Patients who cannot finish the protocol
Target sample size	100

Research contact person
Name of lead principal investigator	Junichiro Irie
Organization	Keio University School of Medicine
Division name	Nephrology, Endocrinology and Metabolism
Address	Shinanomachi 35, Shinjuku, Tokyo, Japan
TEL	03-5363-3797
Email	j-irie@z8.keio.jp

Public contact
Name of contact person	Junichiro Irie
Organization	Keio University School of Medicine
Division name	Nephrology, Endocrinology and Metabolism
Address	Shinanomachi 35, Shinjuku, Tokyo, Japan
TEL	03-5363-3797
Homepage URL	http://www.keio-emn.jp/guidance/index.html
Email	j-irie@z8.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	慶應義塾病院（東京都） Keio University Hospital (Tokyo)

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 27 Day
Anticipated trial start date	2013 Year 06 Month 24 Day
Last follow-up date	2018 Year 11 Month 23 Day
Date of closure to data entry	2023 Year 03 Month 31 Day
Date trial data considered complete	2023 Year 03 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Body weight, metabolic parameter and treatment

Management information
Registered date	2013 Year 07 Month 02 Day
Last modified on	2018 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012995