Clinical trial

Agentic AI Personalized Dietary Management Study

Opening soon · Not applicable · 0 countries · Registry ID NCT07638241

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 90 Years
SexAll
Healthy volunteersAccepted
ConditionDietary Behavior; Metabolic Health; Obesity; Lifestyle Modification; Metabolic Syndrome Risk

Full registry criteria

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.

Treatments and study arms

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.

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.

Primary outcomes

Change in Dietary Behavior ScoreBaseline 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

Study locations

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No public site location was included in this record. Check the original registry for updates.