Agentic AI Personalized Dietary Management Study (AIDiet)
4. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
200
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Suyeon Choi, MD, PhD
- Telefonnummer: 02-2112-5639
- E-mail: 65390@snuh.org
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Control group
Participants receive standard dietary education and perform passive dietary recording during the 12-week study period.
|
|
|
Eksperimentel: Static goal AI intervention group
Participants receive AI-generated personalized dietary goals that are maintained during the 12-week intervention period.
|
The AI algorithm generates individualized dietary goals based on baseline information.
The generated goals are maintained without dynamic adjustment during the intervention period.
|
|
Eksperimentel: Adaptive goal AI intervention group
Participants receive adaptive AI-based dietary tracking, dynamic goal adjustment, and personalized feedback during the 12-week intervention period.
|
The AI algorithm monitors dietary records and relevant participant information, adjusts dietary goals dynamically, and provides personalized feedback to support dietary behavior change.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Dietary Behavior Score
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Body Mass Index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: from baseline to 12 week
|
Change in HbA1c from baseline to 12 weeks.Unit:%
|
from baseline to 12 week
|
|
Change in total cholesterol
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: from baseline to 12 weeks.
|
Changes in triglycerides from baseline to 12 weeks.
|
from baseline to 12 weeks.
|
|
Changes in ALT
Tidsramme: 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
Tidsramme: from baseline to 12 weeks
|
Changes in γ-GTP from baseline to 12 weeks.unit:
U/L
|
from baseline to 12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
8. juni 2026
Primær færdiggørelse (Anslået)
10. september 2026
Studieafslutning (Anslået)
31. december 2028
Datoer for studieregistrering
Først indsendt
31. maj 2026
Først indsendt, der opfyldte QC-kriterier
4. juni 2026
Først opslået (Faktiske)
10. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-2602-154-1723 (Anden identifikator: Seoul National University Hospital IRB)
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