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Feasibility Evaluation of an enhanced AI-Enabled Dietary Fiber Intake Support App in Improving Dietary Habits of Patients with Type 2 Diabetes: A Single-Arm Pre-Post Study

Feasibility Evaluation of an enhanced AI-Enabled Dietary Fiber Intake Support App in Improving Dietary Habits of Patients with Type 2 Diabetes: A Single-Arm Pre-Post Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032250417
Enrollment
35
Registered
2025-10-01
Start date
2025-10-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Type 2 Diabetes

Interventions

The AI-supported dietary fiber intake support system for the participants consists of a smartphone app (iOS and Android) that delivered intervention features to promote dietary fiber intake and an AI-
Diabetes Mellitus, Type 2

Sponsors

Waki Kayo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosed with T2D and attending the hospital/clinic for T2D treatment 2. Own a smartphone with internet data connection and able to receive SMS 3. Willing to take all meal photos with their smartphones, and log them on an app 4. Able to attend research appointments at designated times during the research period 5. 18 or older in age 6. Fluent in spoken and written Japanese 7. In the contemplation, preparation, and action stage to increase dietary fiber intake according to Transtheoretical Model (TTM) of behavior change 8. Determined by the responsible investigator or co-investigator to have no cognitive impairment. 9. Determined by the responsible investigator or co-investigator to be capable of receiving dietary fiber intervention. 10. Has received a thorough explanation about participation in this study and has provided voluntary, written consent based on a complete understanding of the study.

Exclusion criteria

Exclusion criteria: 1. Age 76 years of age and older 2. Judged by physicians to be unsuitable candidate for dietary intervention 3. Currently participating in another clinical research program 4.Currently enrolled or has been enrolled in the past for studies that involve use of older version of the application that will be used for this study 5. Undergoing fiber-restricted diet as ordered by physicians 6. History of eating disorder 7. Currently taking fiber supplements 8. Patients with fluid restriction 9. Patients with Crohn's disease, ulcerative colitis, irritable bowel disease, irritable bowel syndrome, and intestinal obstruction 10. Have taken bowel surgery within the last 3 months 11. Have CKD stage 4 and above 12. Patients with hyperkalemia 13. Patients who are currently pregnant 14. Patients whose smartphones are incompatible with the app, either due to the inability to download or run it effectively 15. Any other reason determined by a physician that deems the patient unfit for participation

Design outcomes

Primary

MeasureTime frame
Self-reported usability feedback from app users, captured through the questionnaire about usability and new features in the application (Created newly)

Secondary

MeasureTime frame
1. Pre-post intervention differences in TPB questionnaire results 2. Number and percentage of days fiber goal is met out of 7 days 3. Number and percentage of implemented solutions in a week 4. Pre-post intervention of the average estimate of fiber intake per day 5. Survey on Participants' Satisfaction and Perceived Usefulness of the App

Contacts

Public ContactShinnosuke Okuyama

Graduate School of Medicine, The University of Tokyo

shinok.154@gmail.com+81-3-5800-9129

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026