UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043641 |
|---|---|
| Receipt number | R000043323 |
| Scientific Title | Effect of nutrition education using vegetable intake measurement device on amount of vegetable intake |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2021/03/17 11:40:32 |
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Basic information
Public title
Effect of nutrition education using vegetable intake measurement device on amount of vegetable intake
Acronym
Effect of nutrition education using vegetable intake measurement device on amount of vegetable intake
Scientific Title
Effect of nutrition education using vegetable intake measurement device on amount of vegetable intake
Scientific Title:Acronym
Effect of nutrition education using vegetable intake measurement device on amount of vegetable intake
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of nutritional education programs on vegetable intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of vegetable intake
Key secondary outcomes
TTM stage of vegetable comsunption
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
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participation in nutrition education program
Measurement with vegetable intake measuring device
Interventions/Control_2
Participation in nutrition education program
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy adults
Key exclusion criteria
Who have any vegetable allergies.
Who receives meal instruction
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Nobuta |
Organization
Kagome Co. LTD.
Division name
Health and wellness business department
Zip code
103-8461
Address
3-21-1 Nihonbashi Hamacho, Tyuou, Tokyo
TEL
03-5623-8501
Yukihiro_Nobuta@kagome.co.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Nobuta |
Organization
Kagome Co. LTD.
Division name
Health and wellness business department
Zip code
103-8461
Address
3-21-1 Nihonbashi Hamacho, Tyuou, 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
Kagome Co. LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kagawa education institute of nutrition
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagome Research Ethics Committee
Address
3-21-1 Nihonbashi Hamacho, Tyuou, Tokyo
Tel
03-5623-8501
Takuji_Hayakawa@kagome.co.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 | 12 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.c-linkage.co.jp/kaizen67/
Publication of results
Published
Result
URL related to results and publications
https://www.c-linkage.co.jp/kaizen67/
Number of participants that the trial has enrolled
190
Results
The intervention group had increased vegetable intake and increased stages of behavioral change.
Results date posted
| 2021 | Year | 03 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
free participation
Participant flow
Fallout
Adverse events
Nothing
Outcome measures
vegetable intake
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | 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=R000043323
