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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026085
Receipt No. 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

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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
Email 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/
Email takezawa@mcube.jp

Sponsor
Institute Yotsuya Medical Cube
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029976

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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