About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Individuals unable to use a smartphone or study-related digital program/application, including those without a smartphone or unable to operate text messaging or application-based functions.
End-stage renal disease or patients currently receiving dialysis
Active cancer or currently undergoing chemotherapy or radiotherapy
Severe heart failure, liver cirrhosis, or hepatic insufficiency accompanied by varices, bleeding, ascites, hepatic encephalopathy, or jaundice
Trial design
Parallel
Treatments tested in this trial
Static AI-based personalized dietary goal setting
BehavioralThe AI algorithm generates individualized dietary goals based on baseline information. The generated goals are maintained without dynamic adjustment during the intervention period.
Adaptive AI-based personalized dietary management
BehavioralThe AI algorithm monitors dietary records and relevant participant information, adjusts dietary goals dynamically, and provides personalized feedback to support dietary behavior change.
Treatment groups
Trial outcomes
Primary outcomes
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
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
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
Secondary outcomes
Change in Body Mass Index
Change in body mass index from baseline to 12 weeks. Unit: kg/m²
Change in Waist Circumference
Change in waist circumference from baseline to 12 weeks. Unit : cm
Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline to 12 weeks.Unit:mmHg
Change in Diastolic Blood Pressure
Change in diastolic blood pressure from baseline to 12 weeks. Unit:mmHg
Sponsors and contacts
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Seoul National University Hospital
Lead sponsor
Ministry of Agriculture, Food and Rural Affairs
Collaborator