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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07524478

Enrollment

300

Registered

2026-04-13

Start date

2026-03-10

Completion date

2027-12-31

Last updated

2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Longevity

Brief 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.

Interventions

COMBINATION_PRODUCTMultidomain 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.

OTHERControl

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to 93 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Cognitive Function	Baseline and 6 months	MoCA

Secondary

Measure	Time frame	Description
Cognitive function	Baseline and 6 months	MMSE

Countries

Japan

Contacts

CONTACTTatsuhiro Hisatsune

hisatsune@edu.k.u-tokyo.ac.jp+81471363632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026