Dietary Behavior; Metabolic Health; Obesity; Lifestyle Modification; Metabolic Syndrome Risk
Conditions
Keywords
Agentic AI; Personalized Nutrition; Digital Health; AI Coaching; Precision Nutrition; Dietary Management; Health Screening
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStatic AI-based personalized dietary goal setting
The AI algorithm generates individualized dietary goals based on baseline information. The generated goals are maintained without dynamic adjustment during the intervention period.
BEHAVIORALAdaptive AI-based personalized dietary management
The AI algorithm monitors dietary records and relevant participant information, adjusts dietary goals dynamically, and provides personalized feedback to support dietary behavior change.
Sponsors
Seoul National University Hospital
Ministry of Agriculture, Food and Rural Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
This is an open-label study. Participants and investigators will be aware of group assignments.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 20 years or older * Individuals from the general population who underwent a health examination at the Seoul National University Hospital Healthcare System Gangnam Center * Individuals who are capable of independently using a smartphone and operating study-related applications or text messaging functions * Individuals without conditions that significantly interfere with standard dietary management, as specified in the
Exclusion criteria
\[Section 9.2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dietary Behavior Score | Baseline and 12 weeks | 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 |
| Outcome Measure: Change in Client Satisfaction Questionnaire Score (CSQ-8) | from baseline to 12 weeks. | 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 |
| Change in System Usability Scale Score (SUS) | from baseline to 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index | Baseline and 12 weeks | Change in body mass index from baseline to 12 weeks. Unit: kg/m² |
| Change in Waist Circumference | from baseline to 12 weeks | Change in waist circumference from baseline to 12 weeks. Unit : cm |
| Change in Systolic Blood Pressure | from baseline to 12 weeks. | Change in systolic blood pressure from baseline to 12 weeks.Unit:mmHg |
| Change in Diastolic Blood Pressure | from baseline to 12 week | Change in diastolic blood pressure from baseline to 12 weeks. Unit:mmHg |
| Change in Fasting Glucose | from baseline to 12 weeks. | Change in fasting glucose from baseline to 12 weeks. Unit:mg/dL |
| Change in HbA1c | from baseline to 12 week | Change in HbA1c from baseline to 12 weeks.Unit:% |
| Change in total cholesterol | from baseline to 12 weeks | Changes in total cholesterol from baseline to 12 weeks. unit: mg/dL |
| Change in AST | from baseline to 12 weeks | Changes in AST from baseline to 12 weeks.unit: U/L |
| Change in Body fat mass | from baseline to 12 weeks | Changes in body fat mass from baseline to 12 weeks. unit : kg |
| Change in skeletal muscle mass | from baseline to 12 weeks | Changes in skeletal muscle mass from baseline to 12 weeks. unit:kg |
| Change in percent body fat | from baseline to 12 weeks. | Changes in percent body fat from baseline to 12 weeks. unit:% |
| Change in body weight (kg) | from baseline to 12 weeks | Change in body weight from baseline to 12 weeks unit: kg |
| Changes in LDL cholesterol | from baseline to 12 weeks | Changes in LDL cholesterol from baseline to 12 weeks. unit: mg/dL |
| Changes in HDL cholesterol | from baseline to 12 weeks | Changes in HDL cholesterol from baseline to 12 weeks. unit: mg/dL |
| Changes in triglycerides | from baseline to 12 weeks. | Changes in triglycerides from baseline to 12 weeks. |
| Changes in ALT | from baseline to 12 weeks | Changes in ALT from baseline to 12 weeks.unit: U/L |
| Changes in γ-GTP | from baseline to 12 weeks | Changes in γ-GTP from baseline to 12 weeks.unit: U/L |
Countries
South Korea
Contacts
CONTACTSuyeon Choi, MD, PhD
Outcome results
None listed