Tokyo, July 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062264) titled 'Multicomponent Behavioral Intervention for Oral Frailty Prevention in Older Adults of Chizu Town, Japan' on July 17.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - National Health Insurance Chizu Hospital

Condition: Condition - Oral frailty (prevention among community-dwelling older adults) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims (1) to evaluate the feasibility and preliminary effects of a comprehensive oral frailty prevention program targeting behavioral change in oral health, mastication, and nutrition - on oral frailty (the primary outcome) and on oral function, dietary variety, physical function, and health-related quality of life (secondary outcomes) - among community-dwelling older adults in Chizu Town, and (2) to explore the program's cost-effectiveness. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - A community-adapted version of the CAMCAM program (developed by Professor Koichiro Matsuo, Institute of Science Tokyo): a three-component combined intervention targeting behavioral change in oral health, mastication, and nutrition. Year 1: four monthly group sessions (approximately 2 hours each) at community centers or other local gathering places. In every session, participants eat the CAMCAM textured lunch - a textured meal designed to promote chewing - and receive education aligned with that session's theme. The 4 sessions cover, in order, an introduction to the link between healthy longevity and oral health, mastication, and nutrition; nutrition and dietary variety; oral health and mastication; and a review of the whole program for integration into daily life. Year 2 onward: an annual consolidated session (approximately 2 to 3 hours) repeated 5 times, for a total of 5 years of in-person delivery per district.

Eligibility: Age-lower limit - 60 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Community-dwelling adults aged 60 years or older residing in Chizu Town who intend to attend all four program sessions and provide written informed consent (primary target population: aged 65 or older, with a planned subgroup analysis). Key exclusion criteria - (1) Certification at Long-Term Care Insurance Care Level 3 or above; (2) serious medical conditions (eg, malignancy or severe cardiac disease) that preclude participation; (3) being judged by the investigator to lack the capacity to provide informed consent (eg, due to dementia); (4) plans to relocate or move to a care facility during the study period. Target Size - 110

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 07 Day Date of IRB - 2026 Year 07 Month 08 Day Anticipated trial start date - 2026 Year 09 Month 16 Day Last follow-up date - 2038 Year 02 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071250

Disclaimer: Curated by HT Syndication.