UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061041 |
|---|---|
| Receipt number | R000067696 |
| Scientific Title | Evaluation of Behavioral Change Effects Induced by an AI-Enabled Health Record Application: A Non-Inferiority Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/24 18:40:20 |
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Basic information
Public title
Evaluation of Behavioral Change Effects Induced by an AI-Enabled Health Record Application: A Non-Inferiority Randomized Controlled Trial
Acronym
Evaluating Behavioral Change Effects of an AI Application: A Non-Inferiority RCT
Scientific Title
Evaluation of Behavioral Change Effects Induced by an AI-Enabled Health Record Application: A Non-Inferiority Randomized Controlled Trial
Scientific Title:Acronym
Evaluating Behavioral Change Effects of an AI Application: A Non-Inferiority RCT
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate, through a randomized controlled trial among young employees of Yamanashi Chuo Bank, whether a fully automated AI-based health intervention delivered via a smartphone application has an equivalent effect to that of a health intervention provided by public health nurses through email.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Outcome
Change in behavioral modification points before and after the intervention in each group.
(These points are designed with reference to the behavioral modification criteria defined in the 4th Term of the Japanese Specific Health Guidance program.)
Key secondary outcomes
Secondary Outcomes
Changes in body weight, BMI, waist circumference, and questionnaire responses before and after the intervention in each group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The AI health application will be installed on each participant's smartphone, and goal setting and health management during the study period will be fully delegated to the app.
Interventions/Control_2
Use of the AI health application will be prohibited, and participants will be asked to set and declare their own goals, with health interventions provided by public health nurses via email every four weeks.
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
| 30 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Among men and women aged 30 to 39 years who work at the implementation site, those who meet the following criteria:
1. A Body Mass Index (BMI) of 23 or higher at this year's health checkup.
2. Possession of a personal smartphone.
3. Written informed consent was obtained for participation in this study.
Key exclusion criteria
Participants who meet any of the following criteria will be excluded:
1. Individuals who, due to physical, mental, or other reasons, are unable to receive health guidance from the staff or are expected to have limitations in participating in the intervention.
Target sample size
142
Research contact person
Name of lead principal investigator
| 1st name | Tadao |
| Middle name | |
| Last name | ooka |
Organization
University of Yamanashi
Division name
Department of Health Sciences
Zip code
4093898
Address
1110, Shimokato, Chuo, Yamanashi
TEL
055-273-9566
tohoka@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Hanawa |
Organization
University of Yamanashi
Division name
Department of Health Sciences
Zip code
4093898
Address
1110, Shimokato, Chuo, Yamanashi
TEL
055-273-9566
Homepage URL
d.hanawa@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Tadao Ooka
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Yamanashi
Address
1110, Shimokato, Chuo, Yamanashi
Tel
055-273-1111
rec-med@yamanashi.ac.jp
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 | 04 | Month | 01 | 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
| 2025 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | 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 | 03 | Month | 24 | Day |
Last modified on
| 2026 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067696
