UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062400 |
|---|---|
| Receipt number | R000071414 |
| Scientific Title | Verification of conditions for the continuation of health behaviors in a lifestyle-review model: transition from guided support to self-management using AI support combined with a health-maintenance support food |
| Date of disclosure of the study information | 2026/07/30 |
| Last modified on | 2026/07/30 12:10:16 |
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Basic information
Public title
Verification of conditions for the continuation of health behaviors in a lifestyle-review model: transition from guided support to self-management using AI support combined with a health-maintenance support food
Acronym
Kushiro Model Study
Scientific Title
Verification of conditions for the continuation of health behaviors in a lifestyle-review model: transition from guided support to self-management using AI support combined with a health-maintenance support food
Scientific Title:Acronym
Kushiro Model Study
Region
| Japan |
Condition
Condition
Not a specific disease. Community-dwelling healthy adults aged 40 years or older (including those in a pre-disease [mibyou] state) who are interested in lifestyle review.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the conditions under which health awareness and health behaviors are maintained after the end of guided support (self-management phase) in a lifestyle-review model, taking into account changes during the guided-support phase. Focusing on six foundational lifestyle elements (sleep, diet, bowel movements, daytime activity, life rhythm, and social engagement), the study examines the conditions for the transition from guided support to self-management, and whether an AI-centered graduation-type (self-management) lifestyle-review model can function as a sustainable health-support model while reducing dependence on human support. This study is not designed to evaluate the efficacy of the supplement alone or its disease-improving effects. The supplement is positioned as a supportive component of lifestyle review, and its association with subjective bodily sensations, health awareness, and continuation of health behaviors is examined exploratorily.
Basic objectives2
Others
Basic objectives -Others
Exploratory investigation of conditions for continued health behavior
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time course of the health-awareness / health-behavior-continuation score (sum of items Q1-Q8 of the weekly self-check, range 0-24). The primary interest is maintenance during the self-management phase relative to the end of guided support (Week 8); the primary comparisons are W8 to W12, W8 to W16, and W8 to W20. Assessment time points: W0, W8, W12, W16, and W20.
Key secondary outcomes
(1) Association between subjective bodily sensation (Q9) and continuation of health behavior; (2) association between self-management confidence (Q10) and continuation; (3) continuation rates (8-week guided-phase completion, 20-week self-management completion), dropout rate and timing; (4) comparison of score trajectories across the guided-to-self-management transition (conditions for established self-management); (5) associations among supplement use, subjective sensation and scores; (6) associations among lifestyle elements; (7) individual differences in continuation patterns (e.g., k-means). Established self-management is primarily defined as the proportion of participants with Q10>=2 in at least 10 of the 12 self-management-phase weeks (>=83%), reported with Wilson 95% confidence intervals.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
A lifestyle-review model (Kushiro Model) is delivered over 20 weeks. Guided-support phase (W1-W8): weekly smartphone-based self-check (items Q1-Q10, each 0-3), weekly AI-assisted reflection support (organized according to preset rules; no medical advice, diagnosis, or treatment instruction is provided), and monthly reflection support by a human supporter. Self-management phase (W9-W20): individual support by the human supporter ends, while weekly self-check and weekly/monthly AI reflection support continue. As a supportive component, a food-derived health supplement (main components: EubioQuercetin [a food-derived material containing rutin, L-arginine, and vitamin C], Shirai Panax notoginseng powder, etc.) is provided free of charge during the study (guide: 2 capsules twice daily, adjustable at the participant's discretion). The supplement is a supportive component of lifestyle review and is not the object of evaluation itself.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Adults aged 40 or older residing in Kushiro City, Hokkaido, or surrounding areas. 2. Interested in health maintenance or lifestyle review. 3. Able to review existing health-checkup results (no new blood sampling). 4. Able to complete a weekly self-check via smartphone, etc. 5. Understand the study and provide written informed consent. 6. Judged capable of self-management regarding lifestyle review and supplement use during the study.
Key exclusion criteria
1. Under treatment for a disease at a medical institution such that participation is judged difficult. 2. Restricted by an attending physician regarding diet, exercise, lifestyle change, or intake of health supplements. 3. History of clear intolerance or adverse reaction to the food-derived components used (rutin, L-arginine, vitamin C, Panax notoginseng, etc.). 4. Judged by the PI as having difficulty understanding the study or maintaining continuous entry due to cognitive/psychological or other reasons. 5. Judged inappropriate for participation by the PI.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Mitsunori |
| Middle name | |
| Last name | Ono |
Organization
Healthy Aging Labs. LLC
Division name
Research Office
Zip code
385-0022
Address
3773-5 Iwamurada, Saku, Nagano
TEL
090-3214-3008
m-ono@halabs.co.jp
Public contact
Name of contact person
| 1st name | Mitsunori |
| Middle name | |
| Last name | Ono |
Organization
Healthy Aging Labs. LLC
Division name
Research Office
Zip code
385-0022
Address
3773-5 Iwamurada, Saku, Nagano
TEL
090-3214-3008
Homepage URL
m-ono@halabs.co.jp
Sponsor or person
Institute
Healthy Aging Labs. LLC
Institute
Department
Personal name
Funding Source
Organization
Healthy Aging Labs. LLC
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Institutional Review Board
Address
DaiwaA Hamamatsucho 6F, 1-9-10 Hamamatsucho, Minato-ku, Tokyo 105-0013, Japan
Tel
03-5408-1555
y_huzita@mail.souken-r.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 30 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071414
