UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063282 |
|---|---|
| Receipt number | R000072437 |
| Scientific Title | A Proof-of-Concept Study of a Public Health Nurse-Supported Digital Dietary Improvement Program for Public Health Nurses, Community Health Class Volunteers, and Older Adult Participants within an Existing Municipal Health Program |
| Date of disclosure of the study information | 2026/10/16 |
| Last modified on | 2026/10/14 20:44:40 |
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Basic information
Public title
A Proof-of-Concept Study of a Public Health Nurse-Supported Digital Dietary Improvement Program for Public Health Nurses, Community Health Class Volunteers, and Older Adult Participants within an Existing Municipal Health Program
Acronym
A Proof-of-Concept Study of a Public Health Nurse-Supported Digital Dietary Improvement Program for Public Health Nurses, Community Health Class Volunteers, and Older Adult Participants within an Existing Municipal Health Program
Scientific Title
A Proof-of-Concept Study of a Public Health Nurse-Supported Digital Dietary Improvement Program for Public Health Nurses, Community Health Class Volunteers, and Older Adult Participants within an Existing Municipal Health Program
Scientific Title:Acronym
A Proof-of-Concept Study of a Public Health Nurse-Supported Digital Dietary Improvement Program for Public Health Nurses, Community Health Class Volunteers, and Older Adult Participants within an Existing Municipal Health Program
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the usability of the Digital Dietary Improvement Program -which features meal logging and dietary habit assessment functions- and its effects on diet-related awareness and behaviors among older adults, as well as its usability and usefulness as a tool to support public health nurses in providing dietary guidance.
Basic objectives2
Others
Basic objectives -Others
Confirmation of efficacy, user experience, etc.
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Acceptability of and intention to continue using the Digital Dietary Improvement Program, including satisfaction, intention for continued use, willingness to recommend it, and usefulness in the workplace.
Key secondary outcomes
Secondary Outcome Measures
1. Changes in food group intake and the food diversity index
2.Changes in attitudes and behaviors related to diet and health
3. Changes in usage of the Digital Dietary Improvement Program
4. Improved work efficiency, reduced workload, and enhanced quality of dietary guidance
Exploratory Outcome Measures
1. Associations between the food diversity index and each outcome measure
2. Free-text responses and interview findings
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Public health nurses use the Digital Dietary Improvement Program to manage the record status of older adults and others, and to support dietary guidance.
Older adults and Community Health Class Volunteers in the program use the Digital Dietary Improvement Program to record and check their own diet and habits, and to use its support features based on those records to improve their dietary lifestyles.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Public Health Nurses]
1. Individuals employed as public health nurses at the participating local government municipality.
2. Individuals who provide dietary guidance as public health nurses using the Digital Dietary Improvement Program in the participating local government municipality's FY2026 "Brain and Body Training Class" program.
3. Individuals who, after reading and fully understanding the explanatory document regarding participation in the PoC study, have provided consent of their own free will.
[Community Health Class Volunteers]
1. Individuals residing in the participating local government municipality.
2. Individuals serving as Community Health Class Volunteers in the participating local government municipality's FY2026 "Brain and Body Training Class" program.
3. Individuals who, after reading and fully understanding the explanatory document regarding participation in the PoC study, have provided consent of their own free will.
[Older Adults]
1. Individuals aged 65 or older at the start of their participation in the "Brain and Body Training Class" and residing in the participating local government municipality.
2. Individuals participating in the participating local government municipality's FY2026 "Brain and Body Training Class" program.
3. Individuals who, after reading and fully understanding the explanatory document regarding participation in the PoC study, have provided consent of their own free will.
Key exclusion criteria
No
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Takada |
Organization
Ajinomoto Co., Inc.
Division name
Research Institute for Bioscience Products and Fine Chemicals
Zip code
210-8681
Address
1-1 Suzuki-cho, Kawasaki-ku, Kawasaki City, Kanagawa Prefecture
TEL
070-1002-5065
michihiro.takada.c5v@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Masatsugu |
| Middle name | |
| Last name | Shimomasuda |
Organization
Ajinomoto Co., Inc.
Division name
Research Institute for Bioscience Products and Fine Chemicals
Zip code
210-8681
Address
1-1 Suzuki-cho, Kawasaki-ku, Kawasaki City, Kanagawa Prefecture
TEL
080-2427-6713
Homepage URL
masatsugu.shimomasud.3de@asv.ajinomoto.com
Sponsor or person
Institute
Ajinomoto Co., Inc.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
AJINOMOTO INSTITUTIONAL REVIEW BOARD
Address
7-1 Kyobashi 1-Chome, Chuo-ku, Tokyo 104-0031, Japan
Tel
03-5250-8111
irb.admin.p52@asv.ajinomoto.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
自治体（Local government municipality）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 16 | 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 | 10 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 26 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 14 | Day |
Last modified on
| 2026 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072437
