UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056212 |
|---|---|
| Receipt number | R000064227 |
| Scientific Title | Questionnaire Study on " Gear-Change in nutrition" in Hyogo Prefecture |
| Date of disclosure of the study information | 2024/11/23 |
| Last modified on | 2024/11/20 13:54:29 |
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Basic information
Public title
Questionnaire Study on " Gear-Change in nutrition" in Hyogo Prefecture
Acronym
"Gear-Change in nutrition" questionnaire study
Scientific Title
Questionnaire Study on " Gear-Change in nutrition" in Hyogo Prefecture
Scientific Title:Acronym
"Gear-Change in nutrition" questionnaire study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to investigate the recognition of the "shift in the mindset of nutrition" implemented to prevent frailty and undernutrition in Hyogo Prefecture
Basic objectives2
Others
Basic objectives -Others
Recognition of "Shift in the Mindset of Nutrition"
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Recognition of healthy eating habits
Awareness of "Gear-Change in nutrition"
Awareness of "frailty"
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Residing in Hyogo Prefecture.
2.Aged 20 years or older.
3.Individuals who have a sufficient understanding of the research content and have provided informed consent to participate in this study voluntarily.
4.Individuals who are able to respond to the questionnaire with their own or their family's assistance.
Key exclusion criteria
None
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Yukikazu |
| Middle name | |
| Last name | Kamada |
Organization
Nestle Japan Ltd
Division name
Nestle Health Science Company
Zip code
140-0002
Address
Tennozu Ocean Square 20F, 2-2-20 Higashi-Shinagawa, Shinagawa-ku, Tokyo
TEL
070-2278-7597
Yukikazu.Kamada@jp.nestle.com
Public contact
Name of contact person
| 1st name | Yukikazu |
| Middle name | |
| Last name | Kamada |
Organization
Nestle Japan Ltd
Division name
Nestle Health Science Company
Zip code
140-0002
Address
Tennozu Ocean Square 20F, 2-2-20 Higashi-Shinagawa, Shinagawa-ku, Tokyo
TEL
070-2278-7597
Homepage URL
Yukikazu.Kamada@jp.nestle.com
Sponsor or person
Institute
Nestle Health Science Company, Nestle Japan Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nestle Japan Ltd and Hyogo Prefecture
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2024 | Year | 11 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 11 | Month | 20 | Day |
Last modified on
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064227
