Agentic AI Personalized Dietary Management Study (AIDiet)
11 september 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
200
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Suyeon Choi, MD, PhD
- Telefoonnummer: 02-2112-5639
- E-mail: 65390@snuh.org
Studie Locaties
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Seoul
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Seoul, Seoul, Zuid -Korea, 06236
- Werving
- Seoul National University Hospital Healthcare System Gangnam Center
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Contact:
- Su-Yeon Choi, PhD
- Telefoonnummer: +82-10-2028-5782
- E-mail: 65390@snuh.org
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: Control group
Participants receive standard dietary education and perform passive dietary recording during the 12-week study period.
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Experimenteel: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Dietary Behavior Score
Tijdsspanne: Baseline 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
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Baseline and 12 weeks
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Outcome Measure: Change in Client Satisfaction Questionnaire Score (CSQ-8)
Tijdsspanne: 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)
Tijdsspanne: 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
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from baseline to 12 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Body Mass Index
Tijdsspanne: Baseline and 12 weeks
|
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: from baseline to 12 week
|
Change in diastolic blood pressure from baseline to 12 weeks.
Unit:mmHg
|
from baseline to 12 week
|
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Change in Fasting Glucose
Tijdsspanne: from baseline to 12 weeks.
|
Change in fasting glucose from baseline to 12 weeks.
Unit:mg/dL
|
from baseline to 12 weeks.
|
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Change in HbA1c
Tijdsspanne: 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
Tijdsspanne: from baseline to 12 weeks
|
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
Tijdsspanne: 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
Tijdsspanne: from baseline to 12 weeks
|
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
Tijdsspanne: from baseline to 12 weeks
|
Changes in skeletal muscle mass from baseline to 12 weeks.
unit:kg
|
from baseline to 12 weeks
|
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Change in percent body fat
Tijdsspanne: 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)
Tijdsspanne: from baseline to 12 weeks
|
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
Tijdsspanne: from baseline to 12 weeks
|
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: from baseline to 12 weeks
|
Changes in ALT from baseline to 12 weeks.unit:
U/L
|
from baseline to 12 weeks
|
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Changes in γ-GTP
Tijdsspanne: from baseline to 12 weeks
|
Changes in γ-GTP from baseline to 12 weeks.unit:
U/L
|
from baseline to 12 weeks
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
11 juni 2026
Primaire voltooiing (Geschat)
26 februari 2027
Studie voltooiing (Geschat)
31 december 2028
Studieregistratiedata
Eerst ingediend
31 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
4 juni 2026
Eerst geplaatst (Werkelijk)
10 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 september 2026
Laatste update ingediend die voldeed aan QC-criteria
11 september 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- H-2602-154-1723 (Andere identificatie: Seoul National University Hospital IRB)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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