Agentic AI Personalized Dietary Management Study (AIDiet)
2026년 9월 11일 업데이트: 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.
연구 개요
상태
모병
상세 설명
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.
연구 유형
중재적
등록 (추정된)
200
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Suyeon Choi, MD, PhD
- 전화번호: 02-2112-5639
- 이메일: 65390@snuh.org
연구 장소
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Seoul
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Seoul, Seoul, 대한민국, 06236
- 모병
- Seoul National University Hospital Healthcare System Gangnam Center
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연락하다:
- Su-Yeon Choi, PhD
- 전화번호: +82-10-2028-5782
- 이메일: 65390@snuh.org
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Control group
Participants receive standard dietary education and perform passive dietary recording during the 12-week study period.
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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Dietary Behavior Score
기간: 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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Body Mass Index
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: from baseline to 12 week
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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
기간: 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
기간: from baseline to 12 weeks
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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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 6월 11일
기본 완료 (추정된)
2027년 2월 26일
연구 완료 (추정된)
2028년 12월 31일
연구 등록 날짜
최초 제출
2026년 5월 31일
QC 기준을 충족하는 최초 제출
2026년 6월 4일
처음 게시됨 (실제)
2026년 6월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 11일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- H-2602-154-1723 (기타 식별자: Seoul National University Hospital IRB)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .