UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049383 |
|---|---|
| Receipt number | R000056224 |
| Scientific Title | Study on effectiveness of text message intervention through a smartphone application targeting shopping mall walkers |
| Date of disclosure of the study information | 2022/11/02 |
| Last modified on | 2023/05/09 13:46:24 |
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Basic information
Public title
Study on effectiveness of text message intervention through a smartphone application targeting shopping mall walkers
Acronym
Study on effectiveness of text message intervention through a smartphone application targeting shopping mall walkers
Scientific Title
Study on effectiveness of text message intervention through a smartphone application targeting shopping mall walkers
Scientific Title:Acronym
Study on effectiveness of text message intervention through a smartphone application targeting shopping mall walkers
Region
| Japan |
Condition
Condition
walking (steps); health conditions; well-being
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the impact of text message intervention through a smartphone application on increasing steps, health conditions, and well-being of shopping mall walkers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
walking (steps)
Key secondary outcomes
health conditions; well-being
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
10
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
A text message intervention through a smartphone application (Pattern A)
Interventions/Control_2
A text message intervention through a smartphone application (Pattern B)
Interventions/Control_3
A text message intervention through a smartphone application (Pattern C)
Interventions/Control_4
A text message intervention through a smartphone application (Pattern D)
Interventions/Control_5
A text message intervention through a smartphone application (Pattern E)
Interventions/Control_6
A text message intervention through a smartphone application (Pattern F)
Interventions/Control_7
A text message intervention through a smartphone application (Pattern G)
Interventions/Control_8
A text message intervention through a smartphone application (Pattern H)
Interventions/Control_9
A text message intervention through a smartphone application (Pattern I)
Interventions/Control_10
No text message intervention for the control group
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult users of a smartphone application for mall walking
Key exclusion criteria
None
Target sample size
15500
Research contact person
Name of lead principal investigator
| 1st name | Masamichi |
| Middle name | |
| Last name | Hanazato |
Organization
Chiba University Center for Preventive Medical Sciences
Division name
HEALTHY PLACES Design Lab.
Zip code
263-8522
Address
1-33, Yayoicho, Inage-ku, Chiba, Japan
TEL
043-290-3877
hanazato@chiba-u.jp
Public contact
Name of contact person
| 1st name | Masamichi |
| Middle name | |
| Last name | Hanazato |
Organization
Chiba University Center for Preventive Medical Sciences
Division name
HEALTHY PLACES Design Lab.
Zip code
263-8522
Address
1-33, Yayoicho, Inage-ku, Chiba, Japan
TEL
043-290-3877
Homepage URL
hanazato@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of the graduate school of medicine, Chiba university
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
Tel
043-226-2501
igaku-rinri@office.chiba-u.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
| 2022 | Year | 11 | Month | 02 | 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
92184
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
| 2022 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 29 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 29 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 29 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 01 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056224
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
