Agentic AI Personalized Dietary Management Study

NCT07638241 | Not Yet Recruiting

• 1 other identifier: H-2602-154-1723
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dietary Behavior; Metabolic Health; Obesity; Lifestyle Modification; Metabolic Syndrome Risk

Keywords

Agentic AI; Personalized Nutrition; Digital Health; AI Coaching; Precision Nutrition; Dietary Management; Health Screening

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (17)

• Change in Body Mass Index

  Baseline and 12 weeks

• Change in Waist Circumference

  from baseline to 12 weeks

• Change in Systolic Blood Pressure

  from baseline to 12 weeks.

• Change in Diastolic Blood Pressure

  from baseline to 12 week

• Change in Fasting Glucose

  from baseline to 12 weeks.

Study Arms (3)

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.

Behavioral: Static AI-based personalized dietary goal setting

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.

Behavioral: Adaptive AI-based personalized dietary management

Interventions

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.

Adaptive goal AI intervention group

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.

Static goal AI intervention group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University: collaborator
• Seoul National University Hospital: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Suyeon Choi, MD, PhD

CONTACT

02-2112-5639; 65390@snuh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants and investigators will be aware of group assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 10, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share