UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048071 |
|---|---|
| Receipt number | R000054783 |
| Scientific Title | An Intervention Study on Health and Dietary Awareness Using the Social Networking Service, LINE(randomized controlled trial ) |
| Date of disclosure of the study information | 2022/06/17 |
| Last modified on | 2023/06/16 09:13:37 |
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Basic information
Public title
An Intervention Study on Health and Dietary Awareness Using the Social Networking Service, LINE
Acronym
Intervention studies using SNS
Scientific Title
An Intervention Study on Health and Dietary Awareness Using the Social Networking Service, LINE(randomized controlled trial )
Scientific Title:Acronym
An Intervention Study on Health and Dietary Awareness Using the Social Networking Service, LINE
Region
| Japan |
Condition
Condition
Health and Dietary Awareness
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify on the effects of offering health and dietary information using the social networking service (SNS) "LINE," which is used by more than 95% young Japanese women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improve health and dietary awareness
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
The content of the information provided to the intervention group was appropriate weight and dietary balance, and nutrients (calcium, iron, vitamin C, dietary fiber, potassium, salt, and fat) and delivere each content twice.
Interventions/Control_2
No intervention
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
| 23 | years-old | > |
Gender
Female
Key inclusion criteria
The first-year female college or university students
Key exclusion criteria
Over 23 years old
People who do not use LINE
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ohtsuki |
Organization
Suzuka University of Medical Science
Division name
Department of Clinical Nutrition
Zip code
510-0293
Address
Kishioka Suzuka Mie
TEL
059-383-8991
ohtsukim@suzuka-u.ac.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Komada |
Organization
Tsu city college
Division name
Department of Food and Nutrition
Zip code
510-0293
Address
15 Issinden Tsu Mie
TEL
059-232-2341
Homepage URL
komada@tsu-cc.ac.jp
Sponsor or person
Institute
Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Yazuya Co., Ltd.
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
The Institutional Review Board of Tsu City College
Address
15 Issinden Tsu Mie
Tel
059-232-2341
komada@tsu-cc.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
| 2022 | Year | 06 | 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
100
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 | 01 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054783
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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