Tokyo, July 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058399) titled 'Evaluation of the Behavioral Change Effects of an Integrated Program on Oral Health and Food Education for Elementary School Children' on July 8.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Institute of Science Tokyo
Condition:
Condition - Oral function in children
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 8
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 Size - 1000
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 01 Day
Anticipated trial start date - 2025 Year 09 Month 01 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066765
Disclaimer: Curated by HT Syndication.