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| ID | Type | Description | Link |
|---|---|---|---|
| H-2602-154-1723 | Other Identifier | Seoul National University Hospital IRB |
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| Name | Class |
|---|---|
| Seoul National University | OTHER |
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This randomized controlled trial aims to evaluate the effectiveness of an Agentic AI-based personalized dietary management algorithm among adults undergoing health screening. Participants will be assigned to a control group, a static goal AI intervention group, or an adaptive goal AI intervention group and followed for 12 weeks.
This study is a randomized controlled trial designed to evaluate whether an Agentic AI-based personalized dietary management algorithm improves dietary behavior and metabolic health indicators among adults undergoing health screening. Eligible participants will be randomly assigned to one of three groups: standard dietary education and passive dietary recording, AI-generated personalized dietary goals maintained throughout the study period, or adaptive AI-based dietary tracking with dynamic goal adjustment and personalized feedback. Outcomes will be assessed at baseline and after 12 weeks, including dietary evaluation index scores and metabolic health-related clinical indicators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Participants receive standard dietary education and perform passive dietary recording during the 12-week study period. | |
| Static goal AI intervention group | Experimental | Participants receive AI-generated personalized dietary goals that are maintained during the 12-week intervention period. |
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| Adaptive goal AI intervention group | Experimental | Participants receive adaptive AI-based dietary tracking, dynamic goal adjustment, and personalized feedback during the 12-week intervention period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Static AI-based personalized dietary goal setting | Behavioral | The AI algorithm generates individualized dietary goals based on baseline information. The generated goals are maintained without dynamic adjustment during the intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dietary Behavior Score | Dietary behavior will be assessed using a 12-item dietary behavior questionnaire derived from a 19-item dietary assessment questionnaire developed and routinely used at Seoul National University Hospital Gangnam Center. Each item is scored on a 3-point scale (1, 3, or 5 points). Total scores range from 12 to 60, with higher scores indicating healthier dietary behaviors. The change in total dietary behavior score from baseline to 12 weeks will be evaluated. unit:score | Baseline and 12 weeks |
| Outcome Measure: Change in Client Satisfaction Questionnaire Score (CSQ-8) | Participant satisfaction with the system will be assessed using the Client Satisfaction Questionnaire-8 (CSQ-8). Total scores range from 8 to 32, with higher scores indicating greater satisfaction with the system.unit:score | from baseline to 12 weeks. |
| Change in System Usability Scale Score (SUS) | System usability will be assessed using the System Usability Scale (SUS). Total scores range from 0 to 100, with higher scores indicating better usability. unit:score | from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index | Change in body mass index from baseline to 12 weeks. Unit: kg/m² | Baseline and 12 weeks |
| Change in Waist Circumference | Change in waist circumference from baseline to 12 weeks. Unit : cm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suyeon Choi, MD, PhD | Contact | 02-2112-5639 | 65390@snuh.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Participants will be randomly assigned to either an AI-based personalized dietary management intervention group or a control group receiving standard nutritional information. The study will be conducted in a parallel-group design to evaluate the effectiveness of the intervention on metabolic health and dietary behaviors.
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This is an open-label study. Participants and investigators will be aware of group assignments.
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| Adaptive AI-based personalized dietary management | Behavioral | The AI algorithm monitors dietary records and relevant participant information, adjusts dietary goals dynamically, and provides personalized feedback to support dietary behavior change. |
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| from baseline to 12 weeks |
| Change in Systolic Blood Pressure | Change in systolic blood pressure from baseline to 12 weeks.Unit:mmHg | from baseline to 12 weeks. |
| Change in Diastolic Blood Pressure | Change in diastolic blood pressure from baseline to 12 weeks. Unit:mmHg | from baseline to 12 week |
| Change in Fasting Glucose | Change in fasting glucose from baseline to 12 weeks. Unit:mg/dL | from baseline to 12 weeks. |
| Change in HbA1c | Change in HbA1c from baseline to 12 weeks.Unit:% | from baseline to 12 week |
| Change in total cholesterol | Changes in total cholesterol from baseline to 12 weeks. unit: mg/dL | from baseline to 12 weeks |
| Change in AST | Changes in AST from baseline to 12 weeks.unit: U/L | from baseline to 12 weeks |
| Change in Body fat mass | Changes in body fat mass from baseline to 12 weeks. unit : kg | from baseline to 12 weeks |
| Change in skeletal muscle mass | Changes in skeletal muscle mass from baseline to 12 weeks. unit:kg | from baseline to 12 weeks |
| Change in percent body fat | Changes in percent body fat from baseline to 12 weeks. unit:% | from baseline to 12 weeks. |
| Change in body weight (kg) | Change in body weight from baseline to 12 weeks unit: kg | from baseline to 12 weeks |
| Changes in LDL cholesterol | Changes in LDL cholesterol from baseline to 12 weeks. unit: mg/dL | from baseline to 12 weeks |
| Changes in HDL cholesterol | Changes in HDL cholesterol from baseline to 12 weeks. unit: mg/dL | from baseline to 12 weeks |
| Changes in triglycerides | Changes in triglycerides from baseline to 12 weeks. | from baseline to 12 weeks. |
| Changes in ALT | Changes in ALT from baseline to 12 weeks.unit: U/L | from baseline to 12 weeks |
| Changes in γ-GTP | Changes in γ-GTP from baseline to 12 weeks.unit: U/L | from baseline to 12 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |