UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048328 |
|---|---|
| Receipt number | R000055080 |
| Scientific Title | Behavior Change Effects of Nutrition Education in Children's Cafeterias |
| Date of disclosure of the study information | 2022/07/09 |
| Last modified on | 2022/07/09 07:03:47 |
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Basic information
Public title
Behavior Change Effects of Nutrition Education in Children's Cafeterias
Acronym
Behavior Change Effects of Nutrition Education in Children's Cafeterias
Scientific Title
Behavior Change Effects of Nutrition Education in Children's Cafeterias
Scientific Title:Acronym
Behavior Change Effects of Nutrition Education in Children's Cafeterias
Region
| Japan |
Condition
Condition
healthy children and parents
Classification by specialty
| Dental medicine | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will (1) clarify the knowledge and awareness of children's cafeteria patrons regarding their oral health and diet, and (2) examine the effectiveness of efforts to increase awareness of oral health and diet among children's cafeteria patrons.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral function (tongue pressure, lip tongue motor function, masticatory function)
Self reported oral health status before and 6months after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
6 month program
1. Eating munchy texture lunch twice a month
2. Receiving lectures about oral health once a month for each
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who can participate for 6 months
Key exclusion criteria
1. individuals who have food allergy
2. individuals who have severe dysphagia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsuo |
Organization
Tokyo Medical and Dental University
Division name
Oral Health Sciences for Community Welfare
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo, Tokyo
TEL
03-5803-4545
matsuo.ohcw@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Rena |
| Middle name | |
| Last name | Hidaka |
Organization
Tokyo Medical and Dental University
Division name
Oral Health Sciences for Community Welfare
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo, Tokyo,
TEL
03-5803-4969
Homepage URL
n-rena.ohcw@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
The Mitsubishi Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo, Tokyo
Tel
03-3813-6111
d-hyoka.adm@tmd.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
| 2022 | Year | 07 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 07 | Month | 09 | Day |
Last modified on
| 2022 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055080
