Agentic AI Personalized Dietary Management Study (AIDiet)
11 de septiembre de 2026 actualizado por: Su-Yeon Choi, Seoul National University Hospital
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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
200
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Suyeon Choi, MD, PhD
- Número de teléfono: 02-2112-5639
- Correo electrónico: 65390@snuh.org
Ubicaciones de estudio
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Seoul
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Seoul, Seoul, Corea del Sur, 06236
- Reclutamiento
- Seoul National University Hospital Healthcare System Gangnam Center
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Contacto:
- Su-Yeon Choi, PhD
- Número de teléfono: +82-10-2028-5782
- Correo electrónico: 65390@snuh.org
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control group
Participants receive standard dietary education and perform passive dietary recording during the 12-week study period.
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Experimental: Static goal AI intervention group
Participants receive AI-generated personalized dietary goals that are maintained during the 12-week intervention period.
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The AI algorithm generates individualized dietary goals based on baseline information.
The generated goals are maintained without dynamic adjustment during the intervention period.
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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.
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The AI algorithm monitors dietary records and relevant participant information, adjusts dietary goals dynamically, and provides personalized feedback to support dietary behavior change.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Dietary Behavior Score
Periodo de tiempo: Baseline and 12 weeks
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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
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Baseline and 12 weeks
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Outcome Measure: Change in Client Satisfaction Questionnaire Score (CSQ-8)
Periodo de tiempo: from baseline to 12 weeks.
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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
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from baseline to 12 weeks.
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Change in System Usability Scale Score (SUS)
Periodo de tiempo: from baseline to 12 weeks
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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
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from baseline to 12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Body Mass Index
Periodo de tiempo: Baseline and 12 weeks
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Change in body mass index from baseline to 12 weeks.
Unit: kg/m²
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Baseline and 12 weeks
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Change in Waist Circumference
Periodo de tiempo: from baseline to 12 weeks
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Change in waist circumference from baseline to 12 weeks.
Unit : cm
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from baseline to 12 weeks
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Change in Systolic Blood Pressure
Periodo de tiempo: from baseline to 12 weeks.
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Change in systolic blood pressure from baseline to 12 weeks.Unit:mmHg
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from baseline to 12 weeks.
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Change in Diastolic Blood Pressure
Periodo de tiempo: from baseline to 12 week
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Change in diastolic blood pressure from baseline to 12 weeks.
Unit:mmHg
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from baseline to 12 week
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Change in Fasting Glucose
Periodo de tiempo: from baseline to 12 weeks.
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Change in fasting glucose from baseline to 12 weeks.
Unit:mg/dL
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from baseline to 12 weeks.
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Change in HbA1c
Periodo de tiempo: from baseline to 12 week
|
Change in HbA1c from baseline to 12 weeks.Unit:%
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from baseline to 12 week
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Change in total cholesterol
Periodo de tiempo: from baseline to 12 weeks
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Changes in total cholesterol from baseline to 12 weeks.
unit: mg/dL
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from baseline to 12 weeks
|
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Change in AST
Periodo de tiempo: from baseline to 12 weeks
|
Changes in AST from baseline to 12 weeks.unit:
U/L
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from baseline to 12 weeks
|
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Change in Body fat mass
Periodo de tiempo: from baseline to 12 weeks
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Changes in body fat mass from baseline to 12 weeks.
unit : kg
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from baseline to 12 weeks
|
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Change in skeletal muscle mass
Periodo de tiempo: from baseline to 12 weeks
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Changes in skeletal muscle mass from baseline to 12 weeks.
unit:kg
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from baseline to 12 weeks
|
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Change in percent body fat
Periodo de tiempo: from baseline to 12 weeks.
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Changes in percent body fat from baseline to 12 weeks.
unit:%
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from baseline to 12 weeks.
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Change in body weight (kg)
Periodo de tiempo: from baseline to 12 weeks
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Change in body weight from baseline to 12 weeks unit: kg
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from baseline to 12 weeks
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Changes in LDL cholesterol
Periodo de tiempo: from baseline to 12 weeks
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Changes in LDL cholesterol from baseline to 12 weeks.
unit: mg/dL
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from baseline to 12 weeks
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Changes in HDL cholesterol
Periodo de tiempo: from baseline to 12 weeks
|
Changes in HDL cholesterol from baseline to 12 weeks.
unit: mg/dL
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from baseline to 12 weeks
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Changes in triglycerides
Periodo de tiempo: from baseline to 12 weeks.
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Changes in triglycerides from baseline to 12 weeks.
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from baseline to 12 weeks.
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Changes in ALT
Periodo de tiempo: from baseline to 12 weeks
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Changes in ALT from baseline to 12 weeks.unit:
U/L
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from baseline to 12 weeks
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Changes in γ-GTP
Periodo de tiempo: from baseline to 12 weeks
|
Changes in γ-GTP from baseline to 12 weeks.unit:
U/L
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from baseline to 12 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
11 de junio de 2026
Finalización primaria (Estimado)
26 de febrero de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
31 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de junio de 2026
Publicado por primera vez (Actual)
10 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de septiembre de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H-2602-154-1723 (Otro identificador: Seoul National University Hospital IRB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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