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Agentic AI Personalized Dietary Management Study (AIDiet)

11. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

200

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Suyeon Choi, MD, PhD
  • Telefonnummer: 02-2112-5639
  • E-Mail: 65390@snuh.org

Studienorte

  • Südkorea
    • Seoul
      • Seoul, Seoul, Südkorea, 06236
        • Rekrutierung
        • Seoul National University Hospital Healthcare System Gangnam Center
        • Kontakt:
          • Su-Yeon Choi, PhD
          • Telefonnummer: +82-10-2028-5782
          • E-Mail: 65390@snuh.org

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Control group
Participants receive standard dietary education and perform passive dietary recording during the 12-week study period.
Experimental: Static goal AI intervention group
Participants receive AI-generated personalized dietary goals that are maintained during the 12-week intervention period.
Verhalten: 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.
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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Dietary Behavior Score
Zeitfenster: 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
Baseline and 12 weeks
Outcome Measure: Change in Client Satisfaction Questionnaire Score (CSQ-8)
Zeitfenster: 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
from baseline to 12 weeks.
Change in System Usability Scale Score (SUS)
Zeitfenster: 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
from baseline to 12 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Body Mass Index
Zeitfenster: Baseline and 12 weeks
Change in body mass index from baseline to 12 weeks. Unit: kg/m²
Baseline and 12 weeks
Change in Waist Circumference
Zeitfenster: from baseline to 12 weeks
Change in waist circumference from baseline to 12 weeks. Unit : cm
from baseline to 12 weeks
Change in Systolic Blood Pressure
Zeitfenster: from baseline to 12 weeks.
Change in systolic blood pressure from baseline to 12 weeks.Unit:mmHg
from baseline to 12 weeks.
Change in Diastolic Blood Pressure
Zeitfenster: from baseline to 12 week
Change in diastolic blood pressure from baseline to 12 weeks. Unit:mmHg
from baseline to 12 week
Change in Fasting Glucose
Zeitfenster: from baseline to 12 weeks.
Change in fasting glucose from baseline to 12 weeks. Unit:mg/dL
from baseline to 12 weeks.
Change in HbA1c
Zeitfenster: from baseline to 12 week
Change in HbA1c from baseline to 12 weeks.Unit:%
from baseline to 12 week
Change in total cholesterol
Zeitfenster: from baseline to 12 weeks
Changes in total cholesterol from baseline to 12 weeks. unit: mg/dL
from baseline to 12 weeks
Change in AST
Zeitfenster: from baseline to 12 weeks
Changes in AST from baseline to 12 weeks.unit: U/L
from baseline to 12 weeks
Change in Body fat mass
Zeitfenster: from baseline to 12 weeks
Changes in body fat mass from baseline to 12 weeks. unit : kg
from baseline to 12 weeks
Change in skeletal muscle mass
Zeitfenster: from baseline to 12 weeks
Changes in skeletal muscle mass from baseline to 12 weeks. unit:kg
from baseline to 12 weeks
Change in percent body fat
Zeitfenster: from baseline to 12 weeks.
Changes in percent body fat from baseline to 12 weeks. unit:%
from baseline to 12 weeks.
Change in body weight (kg)
Zeitfenster: from baseline to 12 weeks
Change in body weight from baseline to 12 weeks unit: kg
from baseline to 12 weeks
Changes in LDL cholesterol
Zeitfenster: from baseline to 12 weeks
Changes in LDL cholesterol from baseline to 12 weeks. unit: mg/dL
from baseline to 12 weeks
Changes in HDL cholesterol
Zeitfenster: from baseline to 12 weeks
Changes in HDL cholesterol from baseline to 12 weeks. unit: mg/dL
from baseline to 12 weeks
Changes in triglycerides
Zeitfenster: from baseline to 12 weeks.
Changes in triglycerides from baseline to 12 weeks.
from baseline to 12 weeks.
Changes in ALT
Zeitfenster: from baseline to 12 weeks
Changes in ALT from baseline to 12 weeks.unit: U/L
from baseline to 12 weeks
Changes in γ-GTP
Zeitfenster: from baseline to 12 weeks
Changes in γ-GTP from baseline to 12 weeks.unit: U/L
from baseline to 12 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Seoul National University Hospital

Mitarbeiter

Ministry of Agriculture, Food and Rural Affairs

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

11. Juni 2026

Primärer Abschluss (Geschätzt)

26. Februar 2027

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

31. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Juni 2026

Zuerst gepostet (Tatsächlich)

10. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. September 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • H-2602-154-1723 (Andere Kennung: Seoul National University Hospital IRB)

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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