UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034219 |
|---|---|
| Receipt number | R000039009 |
| Scientific Title | Verification of the effect of nutrition education program for workers on consciousness and behavior of eating habits on vegetable intake. |
| Date of disclosure of the study information | 2019/12/31 |
| Last modified on | 2018/09/20 16:50:55 |
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Basic information
Public title
Verification of the effect of nutrition education program for workers on consciousness and behavior of eating habits on vegetable intake.
Acronym
Effect of nutrition education program for workers on their vegetable intake.
Scientific Title
Verification of the effect of nutrition education program for workers on consciousness and behavior of eating habits on vegetable intake.
Scientific Title:Acronym
Effect of nutrition education program for workers on their vegetable intake.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of transtheoretical model of vegetable intake on nutrition education program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Transtheoretical model of vegetable consumption.
Key secondary outcomes
1. Habitant background
2. Change factor of transtheoretical model of vegetable consumption.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Nutrition Education
Interventions/Control_2
not 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Workers
Key exclusion criteria
1. Allergic to any vegetables
2. Dietary restriction to any vegetables
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Sone |
Organization
Kagome Co. Ltd.
Division name
Health business department
Zip code
Address
3-21-1, Nihonbashi Hamacho, Tyuo ward, Tokyo
TEL
03-5623-8501
Tomoko_Sone@kagome.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Nobuta |
Organization
Kagome Co. Ltd.
Division name
Health business department
Zip code
Address
3-21-1, Nihonbashi Hamacho, Tyuo ward, Tokyo
TEL
03-5623-8501
Homepage URL
Yukihiro_Nobuta@kagome.co.jp
Sponsor or person
Institute
Kagome Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
none
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)
None
IRB Contact (For public release)
Organization
Address
Tel
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
神奈川県内の企業（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2019 | 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
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 20 | Day |
Last modified on
| 2018 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039009
