UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042132 |
|---|---|
| Receipt number | R000048088 |
| Scientific Title | A study on methods of providing information for behavioral modification of vegetable intake by lifestyle and stages of behavior change among young people |
| Date of disclosure of the study information | 2020/10/15 |
| Last modified on | 2021/10/20 15:14:35 |
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Basic information
Public title
A study on methods of providing information for behavioral modification of vegetable intake by lifestyle and stages of behavior change among young people
Acronym
A study on methods of providing information for behavioral modification of vegetable intake among young people
Scientific Title
A study on methods of providing information for behavioral modification of vegetable intake by lifestyle and stages of behavior change among young people
Scientific Title:Acronym
A study on methods of providing information for behavioral modification of vegetable intake among young people
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the changes of vegetable intake of young people by providing information for behavioral modification of vegetable intake in different methods by lifestyle and stages of behavior of the subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of vegetable intake of the subjects by providing information for behavioral modification of vegetable intake in different methods, at the end of one-month intervention (providing information) and another one month after the end of intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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 |
Interventions/Control_1
Intervention group will be provided information for promoting vegetable intake (nutrients expected by eating vegetables: 2 topics, health effects of nutrients from vegetables: 2 topics, nutrients and health effects in specific vegetable: 2 kinds, how to take vegetables easily: 2 topics) through SNS messages twice a week for one month.
Interventions/Control_2
The same information will be collectively provided at once to the control group through SNS messages.
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
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy people
Key exclusion criteria
Foreigner
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mizumoto |
| Middle name | |
| Last name | Kaori |
Organization
Nakamura Gakuen University
Division name
Department of Food Management, Faculty of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu, Jonan-ku, Fukuoka City, Fukuoka
TEL
092-851-2867
kmizumoto@nakamura-u.ac.jp
Public contact
Name of contact person
| 1st name | Mizumoto |
| Middle name | |
| Last name | Kaori |
Organization
Nakamura Gakuen University
Division name
Department of Food Management, Faculty of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu, Jonan-ku, Fukuoka City, Fukuoka
TEL
092-851-2867
Homepage URL
kmizumoto@nakamura-u.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Research Involving Human Subjects, Nakamura Gakuen University and Junior College
Address
5-7-1 Befu, Jonan-ku, Fukuoka City, Fukuoka
Tel
092-851-2531
kks@nakamura-u.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
| 2020 | Year | 10 | Month | 15 | 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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 10 | Month | 15 | Day |
Last modified on
| 2021 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048088
