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

NCT07524478 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-04-16

No results posted yet for this study

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.

Conditions

  • Healthy Longevity

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.

Sponsors & Collaborators

  • Tatsuhiro Hisatsune

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
93 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-10
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07524478 on ClinicalTrials.gov