Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In Taiwan, an estimated 2.3 million individuals have diabetes, with a 44% increase observed among young adults and adolescents. Poor dietary habits and sedentary lifestyles are major risk factors for type 2 diabetes. The widespread use of smartphones has facilitated the development of digital health technologies, including digital food photography and artificial intelligence (AI), which show promise for personalized nutrition care and health promotion. While such technologies have demonstrated short-term success in diabetes management, their long-term effectiveness remains uncertain.
This study aims to evaluate the effectiveness of a digital eHealth care intervention for individuals with diabetes. Participants will be recruited from the Diabetes Shared Care Network and community care centers in Taiwan and followed for 12 months. Eligible participants will be randomly assigned by computer to either a control or an eHealth care group.
• eHealth Group: Receives a 10-minute digital nutrition education session using the lab-developed "3D/AR MetaFood food portion education platform" (https://sketchfab.com/susanlab108/collections) and is required to submit weekly dietary records through food images using the "Formosa FoodAPP." Participants will receive immediate dietary feedback from nutritionists, followed by AI-generated personalized feedback on the glycemic index (GI) and glycemic load (GL) of their meals. They will also be provided with educational videos on healthy eating, physical activity, and selecting low-GI/GL foods.
Anthropometric measurements and baseline questionnaires will be collected at enrollment. Blood biochemistry, including HbA1c, will be measured at baseline, and at 3, 6, 9, and 12 months. Collected food image data will be used to train AI systems for real-time dietary feedback and to explore the relationship between nutrient intake and long-term glycemic control.
Objective:
This study aims to evaluate the effectiveness of eHealth interventions in the care of patients with diabetes.
Study Design:
Adult participants with diabetes will be recruited from the Diabetes Shared Care Network and community centers for a 12-month intervention study.
Eligibility Criteria:
Participants must be aged 20 years or older, diagnosed with prediabetes or diabetes, of Taiwanese nationality or fluent in Mandarin or Taiwanese, not pregnant or breastfeeding, and capable (or assisted by a caregiver) of using a smartphone to photograph and record meals. Individuals with diagnosed eating disorders will be excluded.
Intervention Arms
• eHealth Group: Participants will receive 10 minutes of portion size and nutrition education using the lab-developed "MetaFood: 3D/AR Digital Food Education Platform" (https://sketchfab.com/susanlab108/collections). They are required to submit a food image-based dietary record once per week using the lab-developed "Formosa FoodAPP" (1). Trained nutritionists will assess the dietary images using a lab-developed "Digital Photographic Food Atlas" and provide real-time dietary feedback via a LINE social group.
Additionally, the eHealth group will receive educational materials including videos and digital leaflets on:
From the 5th month onward, personalized dietary feedback on the GI/GL values of consumed meals will be provided by lab-developed AI systems, continuing until the end of the study. AI systems for food recognition and the LINE group are managed by lab staff.
Biological Measures:
Fasting blood glucose and lipid profiles will be collected every three months during clinic visits.
Sample Size Justification:
Using G*Power 3.1.9.7, the primary endpoint is the effect of AI-supported dietary feedback on glycemic control in middle-aged and older adults with type 2 diabetes. Based on Lee et al.'s study on the combination of human and AI-supported nutrition app, the estimated mean HbA1c difference is 0.52% (7.52±0.81 vs. 7.00±0.66) at 12 months. Assuming an effect size of 0.70, 80% power, and 5% significance, 33 participants per group are needed. Accounting for a 10-20% attrition rate, a total sample of 36-40 participants will be recruited.
Data Collection:
Baseline sociodemographic and anthropometric data will be collected by state-registered dietitians. Standard biochemical test results, available from Taiwan's National Health Insurance, will be collected every three months. Nutrition knowledge, and perceptions and usage of digital food technologies, will be assessed via an online questionnaire developed from the theoretical framework, literature review, and validated by experts. Weekly dietary records will be logged via the Formosa FoodAPP (1).
Data will include:
Statistical Analysis:
Data will be analyzed using GraphPad Prism 5 (La Jolla, CA, USA).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eHealth group | Experimental | Participants in the eHealth group will receive a multi-component digital health intervention. This includes:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real-Time Personalized Dietary Feedback (via AI and Nutritionist) | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | the change of HbA1c | baseline, 3 month, 6 month, 9 month, 12 month |
| Fasting glucose | the change of Fasting glucose | baseline, 3 month, 6 month, 9 month, 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Triglyceride (TG) | the change of Triglyceride (TG) | baseline, 3 month, 6 month, 9 month, 12 month |
| Total cholesterol (TC) | the change of total cholesterol (TC) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-Su Chang, PhD. | Contact | 886-66382736 | 6506 | susanchang@tmu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Jung-Su Chang, PhD. | College of Nutrition, Taipei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jung-Su Chang | Recruiting | Taipei | 110 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37776838 | Background | Ho DKN, Chiu WC, Kao JW, Tseng HT, Yao CY, Su HY, Wei PH, Le NQK, Nguyen HT, Chang JS. Mitigating errors in mobile-based dietary assessments: Effects of a data modification process on the validity of an image-assisted food and nutrition app. Nutrition. 2023 Dec;116:112212. doi: 10.1016/j.nut.2023.112212. Epub 2023 Sep 9. | |
| 36821833 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D064686 | Nutritionists |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| conventional nutrition education by dietitian | Behavioral | The participants receive conventional health and nutrition education from state registered dietitian. |
|
| baseline, 3 month, 6 month, 9 month, 12 month |
| Low-density lipoprotein-cholesterol (LDL-C) | the change of low-density lipoprotein-cholesterol (LDL-C) | baseline, 3 month, 6 month, 9 month, 12 month |
| Triglyceride-glucose (TyG) | the change of triglyceride-glucose (TyG) | baseline, 3 month, 6 month, 9 month, 12 month |
| Estimated Glomerular filtration rate (eGFR) | the change of estimated Glomerular filtration rate (eGFR) | baseline, 3 month, 6 month, 9 month, 12 month |
| Creatinine (CRE) | the change of creatinine (CRE) | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Food portion) | the change of food portion | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Energy) | the change of Energy | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Carbohydrate) | the change of Carbohydrate | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Fiber) | the change of Fiber | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Sugar) | the change of Sugar | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Protein) | the change of Protein | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Fat) | the change of Fat | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Saturated Fat) | the change of Saturated Fat | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Cholesterol) | the change of Cholesterol | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Sodium) | the change of Sodium | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Potassium) | the change of Potassium | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Calcium) | the change of Calcium | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Magnesium) | the change of Magnesium | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Iron) | the change of Iron | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Vitamin C) | the change of Vitamin C | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Dietary GI) | the change of Dietary GI | baseline, 3 month, 6 month, 9 month, 12 month |
| Dietary Intake (Dietary GL) | the change of Dietary GL | baseline, 3 month, 6 month, 9 month, 12 month |
| Lee YB, Kim G, Jun JE, Park H, Lee WJ, Hwang YC, Kim JH. An Integrated Digital Health Care Platform for Diabetes Management With AI-Based Dietary Management: 48-Week Results From a Randomized Controlled Trial. Diabetes Care. 2023 May 1;46(5):959-966. doi: 10.2337/dc22-1929. |