UMIN-CTR Clinical Trial

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
Email	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
Email	n-rena.ohcw@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055080