UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062916 |
|---|---|
| Receipt number | R000072032 |
| Scientific Title | Development and Clinical Evaluation of a Digital Nutrition Management Support Tool to Improve Dietary Therapy Adherence in Patients with Inborn Errors of Metabolism and Intractable Epilepsy |
| Date of disclosure of the study information | 2026/09/14 |
| Last modified on | 2026/09/14 13:34:55 |
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Basic information
Public title
Development and Evaluation of a Web-based Nutrition Management Application for Patients Requiring Special Dietary Therapy and Their Families
Acronym
Digital Adherence for Nutrition-dependent Ailments (The DiANA Study)
Scientific Title
Development and Clinical Evaluation of a Digital Nutrition Management Support Tool to Improve Dietary Therapy Adherence in Patients with Inborn Errors of Metabolism and Intractable Epilepsy
Scientific Title:Acronym
Digital Adherence for Nutrition-dependent Ailments (The DiANA study)
Region
| Japan |
Condition
Condition
Inborn errors of metabolism, Intractable epilepsy (ketogenic diet-eligible cases)
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of a web-based application that automatically calculates disease-specific nutrient intake on dietary therapy adherence, disease management indicators, and patient satisfaction before and after the intervention in patients with inborn errors of metabolism and intractable epilepsy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in nutritional compliance score before and after the intervention (assessed by a registered dietitian). Nutritional compliance score: total score (5-20 points) based on the following 5 items, each rated on a 4-point scale (1-4 points): (i) Management of restricted nutrients; (ii) Appropriateness of food selection; (iii) Use of specialized formula and medical foods; (iv) Maintenance of dietary records; (v) Degree of self-management between outpatient visits
Key secondary outcomes
1. Change in System Usability Scale score before and after the intervention
2. Dietary therapy satisfaction questionnaire score (post-intervention)
3. Continued use rate of the application (at 6 months)
4. Changes in disease-specific management indicators before and after the intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Nutrition management support using the developed web-based application (DiANA app). Patients and their families will be provided with access to the web application via QR code or URL and encouraged to use it freely for daily dietary management. The application automatically calculates methionine, protein, and calorie content of foods, as well as the ketogenic ratio derived from fat, carbohydrate, and protein content. The application is accessible from smartphones, tablets, and personal computers. The intervention period is 6 months, and a registered dietitian will confirm the usage status at each outpatient visit.
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
| 6 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with inborn errors of metabolism requiring daily nutritional management
2. Patients requiring ketogenic diet therapy for seizure management
3. Patients or their families who regularly use a smartphone or tablet device
4. Patients who have started weaning (complementary feeding)
5. Patients or their legally authorized representatives who have provided written informed consent
Key exclusion criteria
1. Patients or their families who do not own a smartphone or tablet device
2. Family members of the principal investigator or co-investigators
3. Others whom the principal investigator deems inappropriate for participation in the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Koga |
Organization
Fukuoka University
Division name
Department of pediatrics, Faculty of medicine
Zip code
814-0180
Address
7-45-1, Nanakuma, Jounanku, Fukuoka, Fukuoka
TEL
092-801-1011
koga12@adm.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | NOBUHIKO |
| Middle name | |
| Last name | KOGA |
Organization
Fukuoka University
Division name
Department of pediatrics, Faculty of medicine
Zip code
814-0180
Address
7-45-1, Nanakuma, Jounanku, Fukuoka, Fukuoka
TEL
0928011011
Homepage URL
koga12@adm.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University
Address
7-45-1, Nanakuma, Jounanku, Fukuoka, Fukuoka
Tel
0928011011
fu-merb-bigvan@fukuoka-u.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 | 09 | Month | 14 | 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 | 09 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 | 09 | Month | 14 | Day |
Last modified on
| 2026 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072032
