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Acceptability and Preliminary Effectiveness of an Online Nutritional Counseling Program for Patients with Type 2 Diabetes Mellitus

Acceptability and Preliminary Effectiveness of an Online Nutritional Counseling Program for Patients with Type 2 Diabetes Mellitus

Waki Kayo

Graduate School of Medicine, The University of Tokyo

7-3-1 Hongo, Bunkyo-ku, Tokyo

kwaki-tky@m.u-tokyo.ac.jp

Wakayama Kaori

Graduate School of Medicine, The University of Tokyo

7-3-1 Hongo, Bunkyo-ku, Tokyo

+81-3-5841-1892

wakayama759@gmail.com

Pending

Aug. 27, 2026

Interventional

randomized controlled trial

single blind

no treatment control/standard of care control

parallel assignment

treatment purpose

1.Diagnosed with type 2 diabetes mellitus and currently receiving treatment at a hospital or clinic.
2.Aged between 18 and 75 years at the time of informed consent.
3.Owns a smartphone with internet access.
4.Able to receive communications from study staff via SMS, LINE, or email.
5.Able to photograph and record all meals and beverages consumed using a smartphone.
6.Able to participate in scheduled online nutritional counseling sessions and study-related interviews during the study period.
7.Able to read, write, and communicate fluently in Japanese.
8.Determined by the principal investigator or sub-investigator not to have cognitive impairment.
9.Determined by the principal investigator or sub-investigator to be eligible for dietary fiber intervention.
10.Has received a full explanation of the study, sufficiently understands the study procedures, and has voluntarily provided written informed consent to participate.

1.Aged 76 years or older.
2.Determined by a physician to be unsuitable for dietary intervention.
3.Has changed medication for the treatment of type 2 diabetes mellitus within the past 8 weeks.
4.Is currently participating in another clinical research program.
5.Is currently following a dietary fiber-restricted diet as directed by a physician.
6.Has a history of an eating disorder.
7.Is currently taking dietary fiber supplements.
8.Is subject to fluid restriction.
9.Has Crohn's disease, ulcerative colitis, inflammatory bowel disease, irritable bowel syndrome, or intestinal obstruction.
10.Has undergone intestinal surgery within the past 3 months.
11.Has stage 4 or higher chronic kidney disease.
12.Has hyperkalemia.
13.Is currently pregnant.
14.Uses a smartphone that is incompatible with MealLog, including being unable to download or effectively use the application.
15.Has any other condition or reason that, in the opinion of the physician, makes participation inappropriate.

Both

Type 2 Diabetes

This study will implement a multifaceted intervention combining an app-based dietary intervention with online nutritional counseling. Following a 2-week app run-in period for all study participants, those assigned to the intervention group will receive the following interventions for 12 weeks:

Use of an AI-Based Dietary Fiber Intake Support Application
Participants will use the application daily to upload meal photographs and record dietary intake through an AI chatbot. Through analysis performed by an AI server, participants will continuously receive real-time feedback and coaching regarding dietary fiber and calorie intake, including goal setting for weekly increases in dietary fiber intake and suggestions for overcoming barriers to achieving these goals.

Online Nutritional Counseling
Participants will receive online nutritional counseling delivered by a registered dietitian at the start of the intervention period (Session 1) and again around Week 6 (Session 2).

Control Group
Participants assigned to the control group will not use the application during the first 10 weeks of the intervention period. During Weeks 11 and 12, they will use a version of the application limited to dietary recording functions only. In addition, participants in the control group will receive online nutritional counseling from a registered dietitian at the start of the intervention period (Session 1) and again around Week 6 (Session 2), in the same manner as the intervention group.

Type 2 Diabetes

Digital therapeutics, smartphone apps, behavior change, online nutrition counseling, type 2 diabetes

D003924

D63731,D015438,D044623,D003924

Acceptability of an online nutrition counseling program, as assessed using the Acceptability of Intervention Measure (AIM) at the end of the intervention period

1. HbA1c
2. Weight
3. BMI
4. Systolic and diastolic blood pressure
5. eGFR
6. Fasting blood glucose
7. LDL cholesterol (LDL-C)
8. HDL cholesterol (HDL-C)
9. Triglycerides
10. Average daily total dietary fiber intake
11. Average daily total energy intake
12. Average daily total sodium intake
13. Average daily total protein intake
14. Average daily total carbohydrate intake
15. Questionnaire on participant experiences
16. Digital health acceptance questionnaire

+81-3-5841-0818

Aug. 18, 2026

No

none