A Randomized Controlled Trial of a Multi-domain Smartphon... | NCT07524478

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

NCT07524478

Sponsor

Tatsuhiro Hisatsune

Status

Recruiting

Last Update Posted

Apr 16, 2026Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Healthy Longevity

Interventions

Multidomain intervention
Control

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2026Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Mar 4, 2026

First Submission Date that Met QC Criteria

Apr 8, 2026

First Posted Date

Apr 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2026

Last Update Posted Date

Apr 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multidomain Intervention	Experimental		Combination Product: Multidomain intervention
Control	Other		Other: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive Function	MoCA	Baseline and 6 months

Secondary Outcomes

Measure	Description	Time Frame
Cognitive function	MMSE	Baseline and 6 months
Cognitive function	SAGE (Self-Administered Gerocognitive Examination)	Baseline and 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Physical conditions that prohibit regular exercise. Individuals diagnosed with dementia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

93 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tatsuhiro Hisatsune	Contact	+81471363632		hisatsune@edu.k.u-tokyo.ac.jp

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSFS, The University of Tokyo	Recruiting	Kashiwa	Chiba	2778562	Japan