Agentic AI Personalized Dietary Management Study (AIDiet)
2026年9月11日 更新者：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.
調査の概要
状態
募集
詳細な説明
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.
研究の種類
介入
入学 (推定)
200
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Suyeon Choi, MD, PhD
- 電話番号：02-2112-5639
- メール：65390@snuh.org
研究場所
-
-
Seoul
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Seoul、Seoul、韓国、06236
- 募集
- Seoul National University Hospital Healthcare System Gangnam Center
-
コンタクト：
- Su-Yeon Choi, PhD
- 電話番号：+82-10-2028-5782
- メール：65390@snuh.org
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Control group
Participants receive standard dietary education and perform passive dietary recording during the 12-week study period.
|
|
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実験的：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.
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Dietary Behavior Score
時間枠：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)
時間枠：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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Body Mass Index
時間枠：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
時間枠：from baseline to 12 weeks
|
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
時間枠：from baseline to 12 weeks.
|
Change in systolic blood pressure from baseline to 12 weeks.Unit:mmHg
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from baseline to 12 weeks.
|
|
Change in Diastolic Blood Pressure
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
|
Change in skeletal muscle mass
時間枠：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
時間枠：from baseline to 12 weeks.
|
Changes in percent body fat from baseline to 12 weeks.
unit:%
|
from baseline to 12 weeks.
|
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Change in body weight (kg)
時間枠：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
時間枠：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
時間枠：from baseline to 12 weeks
|
Changes in HDL cholesterol from baseline to 12 weeks.
unit: mg/dL
|
from baseline to 12 weeks
|
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Changes in triglycerides
時間枠：from baseline to 12 weeks.
|
Changes in triglycerides from baseline to 12 weeks.
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from baseline to 12 weeks.
|
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Changes in ALT
時間枠：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
時間枠：from baseline to 12 weeks
|
Changes in γ-GTP from baseline to 12 weeks.unit:
U/L
|
from baseline to 12 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月11日
一次修了 (推定)
2027年2月26日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年5月31日
QC基準を満たした最初の提出物
2026年6月4日
最初の投稿 (実際)
2026年6月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月15日
QC基準を満たした最後の更新が送信されました
2026年9月11日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- H-2602-154-1723 (その他の識別子：Seoul National University Hospital IRB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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