UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042986 |
|---|---|
| Receipt number | R000049078 |
| Scientific Title | Multicenter randomized controlled trial aimed at improving effects of the motivational support |
| Date of disclosure of the study information | 2021/01/20 |
| Last modified on | 2021/01/13 11:58:21 |
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Basic information
Public title
Download Useful Kind of App for Your Health Study
Acronym
DOUKI-APP STUDY
Scientific Title
Multicenter randomized controlled trial aimed at improving effects of the motivational support
Scientific Title:Acronym
DOUKI-APP STUDY
Region
| Japan |
Condition
Condition
metabolic syndrome
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of adding several apps to the subjects who have not been effective in the past specific health guidance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Percentage of app users after 3 months
Key secondary outcomes
Weight reduction and its rate after 3 months, improvement of clinical test values after 1 year
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
In addition to motivational support, support the introduction of apps according to the action goals at the time of the first interview
Interventions/Control_2
Motivational support as usual
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
| 40 | years-old | <= |
Age-upper limit
| 64 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Among middle-aged workers who are eligible for the specific guidance (motivational support), those who participated in specific health guidance in the past
Key exclusion criteria
Patients treated for serious illnesses such as cancer, cardiovascular disease, renal failure
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kazuyo |
| Middle name | |
| Last name | Tsushita |
Organization
Kagawa Nutrition University
Division name
Graduate Schools of Nutrition Sciences
Zip code
350-0288
Address
3-9-21, Chiyoda, Sakao-city, Saitama, Japan
TEL
049-282-3717
tsushita.kazuyo@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyo |
| Middle name | |
| Last name | Tsushita |
Organization
Kagawa Nutrition University
Division name
Graduate Schools of Nutrition Sciences
Zip code
350-0288
Address
3-9-21, Chiyoda, Sakao-city, Saitama, Japan
TEL
049-282-3717
Homepage URL
http://www.ktsushita.com/cn4/4kenkyu.html
tsushita.kazuyo@eiyo.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Ethics Review Committee of Kagawa Nutrition University
Address
3-9-21, Chiyoda, Sakao-city, Saitama, Japan
Tel
049-282-7331
kenshien@eiyo.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 | 01 | Month | 20 | 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
| 2021 | Year | 01 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | 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 | 01 | Month | 13 | Day |
Last modified on
| 2021 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049078
