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

Recruiting now · Not applicable

Conditions studied: Healthy Longevity

In brief

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.

Key facts

Study ID

NCT07524478

Run by

Tatsuhiro Hisatsune

People needed

300

Starts

2026-03-10

Expected to finish

2027-12-31

Last updated by the study team

2026-04-16

Who can join

Age: 65 and older, up to 93. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to use a smartphone and wearable device (Fitbit).

You may not qualify if…

• Physical conditions that prohibit regular exercise. Individuals diagnosed with dementia

Where it is running

• GSFS, The University of Tokyo — Kashiwa, Chiba, Japan (enrolling)

Full record on ClinicalTrials.gov

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