Agentic AI Personalized Dietary Management Study (AIDiet)
11 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
200
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Suyeon Choi, MD, PhD
- Número de telefone: 02-2112-5639
- E-mail: 65390@snuh.org
Locais de estudo
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-
Seoul
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Seoul, Seoul, Coréia do Sul, 06236
- Recrutamento
- Seoul National University Hospital Healthcare System Gangnam Center
-
Contato:
- Su-Yeon Choi, PhD
- Número de telefone: +82-10-2028-5782
- E-mail: 65390@snuh.org
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Control group
Participants receive standard dietary education and perform passive dietary recording during the 12-week study period.
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|
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Experimental: 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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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.
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Dietary Behavior Score
Prazo: 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)
Prazo: 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
|
from baseline to 12 weeks.
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Change in System Usability Scale Score (SUS)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Body Mass Index
Prazo: 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
Prazo: 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
Prazo: 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.
|
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Change in Diastolic Blood Pressure
Prazo: 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
Prazo: 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
Prazo: from baseline to 12 week
|
Change in HbA1c from baseline to 12 weeks.Unit:%
|
from baseline to 12 week
|
|
Change in total cholesterol
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: from baseline to 12 weeks
|
Changes in LDL cholesterol from baseline to 12 weeks.
unit: mg/dL
|
from baseline to 12 weeks
|
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Changes in HDL cholesterol
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: from baseline to 12 weeks
|
Changes in γ-GTP from baseline to 12 weeks.unit:
U/L
|
from baseline to 12 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
11 de junho de 2026
Conclusão Primária (Estimado)
26 de fevereiro de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
31 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de junho de 2026
Primeira postagem (Real)
10 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
15 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de setembro de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- H-2602-154-1723 (Outro identificador: Seoul National University Hospital IRB)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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