Tokyo, Aug. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058728) titled 'Effect of AI Advisory on Step Count Increase: A Randomized Controlled Trial' on Aug. 7.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - Fujita Health University

Condition: Condition - healthy subjects Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The World Health Organization (WHO) recommends that adults engage in physical activity in its guidelines on physical activity and sedentary behavior. Physical activity is associated with various health benefits, including reduced all-cause and cardiovascular mortality, prevention of hypertension, site-specific cancers, and type 2 diabetes, as well as improvements in mental health. Similarly, the Japanese Ministry of Health, Labour and Welfare emphasizes the importance of physical activity in its 2023 Physical Activity and Exercise Guidelines for Health Promotion, recommending that adults aim to walk approximately 8,000 steps per day. In recent years, mobile applications have gained attention as tools to promote behavioral change necessary to increase physical activity in daily life. Furthermore, with rapid advancements in artificial intelligence (AI) technologies, some applications have demonstrated improved health outcomes by providing personalized advice based on AI models. Although some of these applications have been implemented in Japan, limited data are available regarding their effectiveness in increasing step counts.

The aim of this study is to evaluate the effectiveness of AI-generated advice delivered via a mobile application in increasing daily step counts. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - An application equipped with an AI advisory function Interventions/Control_2 - An application equipped without an AI advisory function

Eligibility: Age-lower limit - 22 years-old

Gender - Male and Female Key inclusion criteria - 1.Written informed consent will be obtained from each participant after providing a thorough explanation of the study and ensuring full understanding and voluntary agreement. 2.Participants must be aged 22 years or older and younger than 65 years at the time of consent. 3.Participants must be able to read Japanese. 4.Participants must be able to walk more than 10 steps without using a cane, walker, or wheelchair. 5.Participants must own a device compatible with the iOS operating system. Key exclusion criteria - 1.Individuals whose physical activity has been restricted by a physician will be excluded from the study. 2.Those who have experienced a myocardial infarction or stroke within the past six months will also be excluded. 3.Individuals with a systolic blood pressure of 180 mmHg or higher, or a diastolic blood pressure of 110 mmHg or higher, will not be eligible to participate. 4.Pregnant individuals, as well as those who plan to become pregnant during the study period, will be excluded. 5.In addition, individuals who are deemed unsuitable for participation by the principal investigator or co-investigators for any reason will not be included in the study. Target Size - 300

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 18 Day Date of IRB - 2025 Year 07 Month 18 Day Anticipated trial start date - 2025 Year 08 Month 08 Day Last follow-up date - 2025 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067144

Disclaimer: Curated by HT Syndication.