UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045683 |
|---|---|
| Receipt number | 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 13:34:09 |
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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
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
kanekohidehiro@gmail.com
Sponsor or person
Institute
Tokyo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052027
