UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058399 |
|---|---|
| Receipt number | R000066765 |
| Scientific Title | Evaluation of the Behavioral Change Effects of an Integrated Program on Oral Health and Food Education for Elementary School Children |
| Date of disclosure of the study information | 2025/07/08 |
| Last modified on | 2025/07/08 12:46:00 |
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Basic information
Public title
Evaluation of the Behavioral Change Effects of an Integrated Program on Oral Health and Food Education for Elementary School Children
Acronym
Evaluation of the Behavioral Change Effects of an Integrated Program on Oral Health and Food Education for Elementary School Children
Scientific Title
Evaluation of the Behavioral Change Effects of an Integrated Program on Oral Health and Food Education for Elementary School Children
Scientific Title:Acronym
Evaluation of the Behavioral Change Effects of an Integrated Program on Oral Health and Food Education for Elementary School Children
Region
| Japan |
Condition
Condition
Oral function in children
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine whether literacy and behaviors related to oral health, nutrition, and mastication can be improved or maintained by providing elementary school children with a special lunch (the "Kamu-Kamu School Lunch") designed to promote chewing, along with a lecture focusing on oral health, nutrition, and mastication.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transtheoretical Model for Oral health, nutrition, and mastication
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
During a four-month school semester, informational sessions on oral health, nutrition, and mastication were provided once a month, and students were given specially designed school lunches to promote proper chewing behavior.
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
| 8 | years-old | <= |
Age-upper limit
| 12 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Written informed consent was obtained from both the participant and their legal guardian (parent) based on their voluntary decision, after receiving a full explanation of the study and demonstrating sufficient understanding.
Individuals who were able to participate in the intervention over the course of one school semester (four months).
Key exclusion criteria
Individuals with food allergies (those who do not consume the school lunch provided at the participating school)
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Rena |
| Middle name | |
| Last name | Hidaka |
Organization
Institute of Science Tokyo
Division name
Department of Oral Helath Sciences for Community Welfare
Zip code
113-8510
Address
1-5-45, Yuchima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4971
n-rena.ohcw@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Rena |
| Middle name | |
| Last name | Hidaka |
Organization
Institute of Science Tokyo
Division name
Department of Oral Helath Sciences for Community Welfare
Zip code
113-8510
Address
1-5-45, Yuchima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4971
Homepage URL
n-rena.ohcw@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of the Department of Dentistry, Tokyo University of Science
Address
1-5-45, Yuchima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-4547
rinri.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
| 2025 | Year | 07 | Month | 08 | 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
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | 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
| 2025 | Year | 07 | Month | 08 | Day |
Last modified on
| 2025 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066765
