Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061041) titled 'Evaluation of Behavioral Change Effects Induced by an AI-Enabled Health Record Application: A Non-Inferiority Randomized Controlled Trial' on April 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - University of Yamanashi

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate, through a randomized controlled trial among young employees of Yamanashi Chuo Bank, whether a fully automated AI-based health intervention delivered via a smartphone application has an equivalent effect to that of a health intervention provided by public health nurses through email. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The AI health application will be installed on each participant's smartphone, and goal setting and health management during the study period will be fully delegated to the app. Interventions/Control_2 - Use of the AI health application will be prohibited, and participants will be asked to set and declare their own goals, with health interventions provided by public health nurses via email every four weeks.

Eligibility: Age-lower limit - 30 years-old = Gender - Male and Female Key inclusion criteria - Among men and women aged 30 to 39 years who work at the implementation site, those who meet the following criteria: 1. A Body Mass Index (BMI) of 23 or higher at this year's health checkup. 2. Possession of a personal smartphone. 3. Written informed consent was obtained for participation in this study. Key exclusion criteria - Participants who meet any of the following criteria will be excluded: 1. Individuals who, due to physical, mental, or other reasons, are unable to receive health guidance from the staff or are expected to have limitations in participating in the intervention. Target Size - 142

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 31 Day Date of IRB - 2025 Year 12 Month 05 Day Anticipated trial start date - 2025 Year 12 Month 05 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067696

Disclaimer: Curated by HT Syndication.