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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000045683
Receipt No. R000052027
Scientific Title A randomized controlled trial examining optimal guidance aimed at weight management.
Date of disclosure of the study information 2021/10/11
Last modified on 2021/10/06

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Basic information
Public title A randomized controlled trial examining optimal guidance aimed at weight management.
Acronym Research on weight management with email.
Scientific Title A randomized controlled trial examining optimal guidance aimed at weight management.
Scientific Title:Acronym Research on weight management with email.
Region
Japan

Condition
Condition The patients who have undergone a physical examination at the Center for Preventive Medicine of the University of Tokyo Hospital and have been diagnosed as obese (Body Mass Index =>25).
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Regular contact and asking about weight will be used to evaluate the effect of the program on obesity and lifestyle-related disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes One-year weight change, presence of lifestyle-related diseases.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Monthly weight report by email and noted weight.
Interventions/Control_2 control
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

Not applicable
Gender Male and Female
Key inclusion criteria Those who have been diagnosed as obese in the physical examination and wish to have the physical examination again in one year.
Those who are 20 years old or older at the time of obtaining consent.
Those who have received sufficient explanations about participation in this study, and have given their free and voluntary consent with full understanding.
Key exclusion criteria Patients who have difficulty contacting e-mail at night
Patients for whom the usual weight management guidance is considered inappropriate
Hemodialysis patients
Patients deemed inappropriate for participation in the study by the principal investigator
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Kaneko
Middle name
Last name Hidehiro
Organization University of Tokyo Hospital
Division name Department of Advanced Cardiology
Zip code 113-8655
Address Hongo 7-3-1 Bunkyo-ku Tokyo
TEL 0338155411
Email kanekohidehiro@gmail.com

Public contact
Name of contact person
1st name Kaaneko
Middle name
Last name Hidehiro
Organization University of Tokyo Hospital
Division name Department of Advanced Cardiology
Zip code 113-8655
Address Hongo 7-3-1 Bunkyo-ku Tokyo
TEL 0338155411
Homepage URL
Email kanekohidehiro@gmail.com

Sponsor
Institute Tokyo University
Institute
Department

Funding Source
Organization self
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Promotion Center
Address Hongo 7-3-1 Bunkyo-ku Tokyo
Tel 03-5800-8743
Email one-stop@umin.ac.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
2021 Year 10 Month 11 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
2019 Year 11 Month 15 Day
Date of IRB
2019 Year 11 Month 15 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2022 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
2021 Year 10 Month 06 Day
Last modified on
2021 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052027

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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