Agentic AI Personalized Dietary Management Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Change in Dietary Behavior Score [Срок оценки: Baseline and 12 weeks]
• Outcome Measure: Change in Client Satisfaction Questionnaire Score (CSQ-8) [Срок оценки: from baseline to 12 weeks.]
• Change in System Usability Scale Score (SUS) [Срок оценки: from baseline to 12 weeks]

Вторичные конечные точки (12)

• Change in Body Mass Index [Срок оценки: Baseline and 12 weeks]
• Change in Waist Circumference [Срок оценки: from baseline to 12 weeks]
• Change in Systolic Blood Pressure [Срок оценки: from baseline to 12 weeks.]
• Change in Diastolic Blood Pressure [Срок оценки: from baseline to 12 week]
• Change in Fasting Glucose [Срок оценки: from baseline to 12 weeks.]
• Change in HbA1c [Срок оценки: from baseline to 12 week]
• Change in total cholesterol [Срок оценки: from baseline to 12 weeks]
• Change in AST [Срок оценки: from baseline to 12 weeks]
• Change in Body fat mass [Срок оценки: from baseline to 12 weeks]
• Change in skeletal muscle mass [Срок оценки: from baseline to 12 weeks]
• Change in percent body fat [Срок оценки: from baseline to 12 weeks.]
• Change in body weight (kg) [Срок оценки: from baseline to 12 weeks]

Критерии участия

Критерии включения

• 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 \[Section 9.2 Exclusion Criteria\]

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07638241 · H-2602-154-1723 · H-2602-154-1723

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗