UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026085 |
|---|---|
| Receipt number | R000029976 |
| Scientific Title | Real-time wireless pedometers for reaching target total steps during preoperative weight-loss period for bariatric surgery: Prospective study |
| Date of disclosure of the study information | 2017/02/14 |
| Last modified on | 2017/02/10 16:08:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Real-time wireless pedometers for reaching target total steps during preoperative weight-loss period for bariatric surgery: Prospective study
Acronym
A pilot study for testing usability of real-time wireless pedometers for bariatric surgery
Scientific Title
Real-time wireless pedometers for reaching target total steps during preoperative weight-loss period for bariatric surgery: Prospective study
Scientific Title:Acronym
A pilot study for testing usability of real-time wireless pedometers for bariatric surgery
Region
| Japan |
Condition
Condition
Morbid obesity
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate total steps of morbid patients who undergo bariatric surgery as subjective exercise index
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients who reach target total steps( Male:9000 steps, Female:8500 steps)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Raal-time wireless pedometer (MOVEBAND3)
Interventions/Control_2
classical pedometer
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible to bariatirc surgery, possessing smart phones
Key exclusion criteria
Not eligible to bariatric surgery
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kotaro Wakamatsu |
Organization
Yotsuya Medical Cube
Division name
Weight loss and Metabolic surgery center
Zip code
Address
7-7 Nibancho, Chiyoda-ku, Tokyo
TEL
03-3561-0401
kotarowakamatsu79@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ai Takezawa |
Organization
Yotsuya Medical Cube
Division name
Weight loss and Metabolic surgery center
Zip code
Address
7-7 Nibancho, Chiyoda-ku, Tokyo
TEL
03-3561-0401
Homepage URL
http://mcube.jp/
takezawa@mcube.jp
Sponsor or person
Institute
Yotsuya Medical Cube
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 02 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 14 | 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 | 02 | Month | 10 | Day |
Last modified on
| 2017 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029976
