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NCT Number: NCT07524478

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

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.

Recruiting

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Key information

Conditions

Age range

65 year–93 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GSFS, The University of Tokyo

Kashiwa, Chiba, 2778562, Japan

Location status: Recruiting

Location contact

Tatsuhiro Hisatsune

CONTACT

[email protected]

+81471363632

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Multidomain intervention

Combination Product

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.

Control

Other

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

Primary outcomes

  1. Cognitive Function

    Time frame: Baseline and 6 months

    MoCA

Secondary outcomes

  1. Cognitive function

    Time frame: Baseline and 6 months

    MMSE

  2. Cognitive function

    Time frame: Baseline and 6 months

    SAGE (Self-Administered Gerocognitive Examination)

Study contacts

Contact information is provided by the study sponsor or research team.

Tatsuhiro Hisatsune

CONTACT

[email protected]

+81471363632

Sponsors and collaborators

Lead sponsor

Tatsuhiro Hisatsune

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.