UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043640 |
|---|---|
| Receipt number | R000049839 |
| Scientific Title | Effects of E-Learning Motivation for Workers and Promotion of Self-Monitoring of Vegetable Intake Using an App on Vegetable Intake |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2021/03/17 11:31:11 |
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Basic information
Public title
Effects of E-Learning Motivation for Workers and Promotion of Self-Monitoring of Vegetable Intake Using an App on Vegetable Intake
Acronym
Effects of Nutrition Education Programs on Vegetable Intake
Scientific Title
Effects of E-Learning Motivation for Workers and Promotion of Self-Monitoring of Vegetable Intake Using an App on Vegetable Intake
Scientific Title:Acronym
Effects of Nutrition Education Programs on Vegetable Intake
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect on vegetable intake
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
vegetable intake
Key secondary outcomes
stage of behavior change
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
e-learning motivations
Interventions/Control_2
Promoting self-monitoring with apps
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
worker
Key exclusion criteria
Those who are on a restricted diet under the supervision of a doctor or registered dietitian.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Nobuta |
| Middle name | |
| Last name | Yukihiro |
Organization
KAGOME CO., LTD.
Division name
Health & Business Department
Zip code
103-8461
Address
Nihonbashi-Hamacho F Tower, 3-21-1Nihonbashi-Hamacho, Chuo-ku, Tokyo
TEL
03-5623-8501
Yukihiro_Nobuta@kagome.co.jp
Public contact
Name of contact person
| 1st name | Nobuta |
| Middle name | |
| Last name | Yukihiro |
Organization
KAGOME CO., LTD.
Division name
Health & Business Department
Zip code
103-8461
Address
Nihonbashi-Hamacho F Tower, 3-21-1Nihonbashi-Hamacho, Chuo-ku, Tokyo
TEL
03-5623-8501
Homepage URL
Yukihiro_Nobuta@kagome.co.jp
Sponsor or person
Institute
KAGOME CO., LTD. Health & Business Department
Institute
Department
Personal name
Funding Source
Organization
KAGOME CO., LTD.Health & Business Department
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kagawa Nutrition University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagome Research Ethics Review Board
Address
Nihonbashi-Hamacho F Tower, 3-21-1Nihonbashi-Hamacho, Chuo-ku, Tokyo
Tel
03-5623-8501
takuji_hayakawa@kagome.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020R09
Org. issuing International ID_1
Kagome Research Ethics Review Board
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 | 12 | Month | 31 | 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
284
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
| 2020 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | 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 | 03 | Month | 17 | Day |
Last modified on
| 2021 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049839
