Agentic AI Personalized Dietary Management Study (AIDiet)
11 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
200
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Suyeon Choi, MD, PhD
- Numéro de téléphone: 02-2112-5639
- E-mail: 65390@snuh.org
Lieux d'étude
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Seoul
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Seoul, Seoul, Corée du Sud, 06236
- Recrutement
- Seoul National University Hospital Healthcare System Gangnam Center
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Contact:
- Su-Yeon Choi, PhD
- Numéro de téléphone: +82-10-2028-5782
- E-mail: 65390@snuh.org
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Control group
Participants receive standard dietary education and perform passive dietary recording during the 12-week study period.
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Expérimental: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Dietary Behavior Score
Délai: 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)
Délai: 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)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Body Mass Index
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: from baseline to 12 weeks.
|
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)
Délai: 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
Délai: 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
Délai: from baseline to 12 weeks
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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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
11 juin 2026
Achèvement primaire (Estimé)
26 février 2027
Achèvement de l'étude (Estimé)
31 décembre 2028
Dates d'inscription aux études
Première soumission
31 mai 2026
Première soumission répondant aux critères de contrôle qualité
4 juin 2026
Première publication (Réel)
10 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 septembre 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- H-2602-154-1723 (Autre identifiant: Seoul National University Hospital IRB)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
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