Agentic AI Personalized Dietary Management Study (AIDiet)

Effectiveness of an Agentic AI-Based Personalized Dietary Management Algorithm in Health Screening Participants: A Randomized Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dietary Behavior; Metabolic Health; Obesity; Lifestyle Modification; Metabolic Syndrome Risk
• Intervention / Treatment: Behavioral: Static AI-based personalized dietary goal setting; Behavioral: Adaptive AI-based personalized dietary management

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suyeon Choi, MD, PhD; Phone Number: 02-2112-5639; Email: 65390@snuh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Exclusion Criteria]

Exclusion Criteria:

• 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
• Malabsorption disorders such as Crohn's disease or short bowel syndrome
• Poorly controlled hyperthyroidism or hypothyroidism
• Diagnosed eating disorders or severe psychiatric disorders
• Pregnant or breastfeeding women, or women who may become pregnant during study participation.
• Individuals with recent major weight-related interventions or extreme body weight changes within the past 3 months, including:Bariatric surgery such as gastrectomy or gastric bypass surgery Newly initiated anti-obesity pharmacotherapy (e.g., semaglutide/Wegovy, tirzepatide/Mounjaro)
• Individuals considered by the investigator to have poor compliance potential or otherwise deemed unsuitable for participation in the clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Participants receive standard dietary education and perform passive dietary recording during the 12-week study period.
Experimental: Static goal AI intervention group; Participants receive AI-generated personalized dietary goals that are maintained during the 12-week intervention period.	Behavioral: Static 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.
Experimental: Adaptive goal AI intervention group; Participants receive adaptive AI-based dietary tracking, dynamic goal adjustment, and personalized feedback during the 12-week intervention period.	Behavioral: Adaptive 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University

Study record dates

Study Major Dates

• Study Start (Estimated): June 8, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 31, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Agentic AI; Personalized Nutrition; Digital Health; AI Coaching; Precision Nutrition; Dietary Management; Health Screening
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: H-2602-154-1723 (Other Identifier: Seoul National University Hospital IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No