UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037392 |
|---|---|
| Receipt number | R000042632 |
| Scientific Title | Research on the effect of C2C Web mental support |
| Date of disclosure of the study information | 2019/07/17 |
| Last modified on | 2019/12/25 10:47:17 |
* 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
Research on the effect of C2C Web mental support
Acronym
Research on the effect of C2C Web mental support
Scientific Title
Research on the effect of C2C Web mental support
Scientific Title:Acronym
Research on the effect of C2C Web mental support
Region
| Japan |
Condition
Condition
People who do not have exercise habits
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of C2C Web mental support exploratoryly
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS (short version) at the beginning, first month, second month and the end of the study period.
Key secondary outcomes
Exercise change stage scale
Exercise self-efficacy scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mentoring by ordinary people
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Adults aged 20 to 65
(2) Exercise non-habitant
(3) Japanese-language conversation, answer to questionnaires possible
(4) No resistance in SNS communication
(5) Understood the purpose of this research and agreed to participate
Key exclusion criteria
(1) Can not handle Web interface
(2) Significant cognitive and mental disorder
(3) Other health problems which make it difficult to participate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasunori |
| Middle name | |
| Last name | Sato |
Organization
Keio University
Division name
Department of Preventive Medicine and Public Health
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-5363-3662
yasunori.sato@keio.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Muraoka |
Organization
Keio University Graduate School
Division name
Health management
Zip code
252-0883
Address
4411 Endo, Fujisawa, Kanagawa
TEL
0466-49-6200
Homepage URL
h.m.kicking_back420@hotmail.co.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Keio University Graduate School
Address
4411 Endo, Fujisawa, Kanagawa
Tel
0466-49-6200
nmc-hm@adst.keio.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
| 2019 | Year | 07 | Month | 17 | 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
41
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
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 16 | Day |
Last modified on
| 2019 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042632
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
