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RECRUITING
NCT07524478
NA

A Randomized Controlled Trial of a Multi-domain Smartphone Intervention Incorporating Generative AI for Healthy Older Adults

Sponsor: Tatsuhiro Hisatsune

View on ClinicalTrials.gov

Summary

This study evaluates the efficacy of a smartphone-based multi-domain intervention designed to promote healthy aging and prevent cognitive decline in older adults. Building on preliminary findings that automated alerts improved exercise, sleep and nutrition-thereby mediating enhanced cognitive performance-we developed a dedicated application that integrates longitudinal Fitbit data (activity, sleep, and nutrition) with daily interactive dialogues powered by Generative AI (LLM). A six-month Randomized Controlled Trial (RCT) will be conducted with 300 healthy participants aged 65 and older. The primary objective is to analyze how these digital interventions influence health outcomes, particularly cognitive and motor functions. Furthermore, we aim to construct a predictive mathematical model to estimate health states based on wearable data streams. Finally, the study will assess the potential for scalability to facilitate the large-scale social implementation of this digital health service.

Official title: Efficacy and Scalability of a Multi-domain Digital Health Intervention Via Smartphone Application and Wearable Data: A Randomized Controlled Trial in Healthy Elderly Population

Key Details

Gender

All

Age Range

65 Years - 93 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-03-10

Completion Date

2027-12-31

Last Updated

2026-04-16

Healthy Volunteers

Yes

Interventions

COMBINATION_PRODUCT

Multidomain intervention

Multi-domain App Intervention: Participants receive a dedicated smartphone application integrated with Fitbit. The app provides guidance on exercise, sleep, and nutrition, and features daily interactive dialogues powered by Generative AI (LLM) to promote health engagement.

OTHER

Control

Standard Care: Participants may receive standard health information without the specialized multi-domain app or AI dialogue features.

Locations (1)

GSFS, The University of Tokyo

Kashiwa, Chiba, Japan