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
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2026
CompletedStudy Start
First participant enrolled
March 10, 2026
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 16, 2026
April 1, 2026
10 months
March 4, 2026
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Cognitive Function
MoCA
Baseline and 6 months
Secondary Outcomes (2)
Cognitive function
Baseline and 6 months
Cognitive function
Baseline and 6 months
Study Arms (2)
Multidomain Intervention
EXPERIMENTALControl
OTHERInterventions
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.
Standard Care: Participants may receive standard health information without the specialized multi-domain app or AI dialogue features.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GSFS, The University of Tokyo
Kashiwa, Chiba, 2778562, Japan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 4, 2026
First Posted
April 13, 2026
Study Start
March 10, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
April 16, 2026
Record last verified: 2026-04