Actively Recruiting

Phase Not Applicable
Age: 65Years - 93Years
All Genders
Healthy Volunteers
NCT07524478

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

Led by Tatsuhiro Hisatsune · Updated on 2026-04-16

300

Participants Needed

1

Research Sites

94 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years - 93Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to use a smartphone and wearable device (Fitbit).
Not Eligible

You will not qualify if you...

  • Physical conditions that prohibit regular exercise.
  • Diagnosed with dementia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

GSFS, The University of Tokyo

Kashiwa, Chiba, Japan, 2778562

Actively Recruiting

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Research Team

T

Tatsuhiro Hisatsune

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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