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NutriTrack: AI-Assisted Nutritional Tracking in the Obesity Clinic (NUTRITRACK)

6 de maio de 2026 atualizado por: Francisco José García González

NutriTrack: An Artificial Intelligence Application for Nutritional and Behavioral Tracking in Patients With Obesity in an Outpatient Obesity Clinic: A Prospective Observational Pilot Study

NutriTrack is a digital health application designed to support nutritional and behavioral tracking in patients with obesity followed in an outpatient obesity clinic. The application allows patients to record food intake using food photographs, barcode scanning, or manual search, and to register behavioral variables related to eating episodes.

This prospective, single-center, observational pilot study will evaluate the feasibility and usability of NutriTrack in 20 to 50 adult patients with obesity or overweight with comorbidities followed at the Obesity Clinic of Hospital Clínico San Carlos. Participants will use the application for 4 weeks as a complementary tool. The information generated by NutriTrack will be available to healthcare professionals as supportive information and will not replace clinical judgment or modify usual care decisions.

The main outcome is usability measured using the System Usability Scale. Secondary and exploratory outcomes include agreement between artificial intelligence-based nutritional estimates and standard dietitian assessment, adherence to daily food logging, professional perceived clinical utility, changes in eating behavior and emotional regulation scales, and technical feasibility of data export.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

NutriTrack is a digital health application developed within Hospital Clínico San Carlos and Universidad Complutense de Madrid to support nutritional and behavioral tracking in patients with obesity. The application integrates artificial intelligence-based food image recognition, the Spanish BEDCA nutritional database, and a rule-based engine for the detection of clinically relevant eating patterns.

This is a prospective, single-center, observational pilot study with complementary clinical use. The application will be used by adult patients followed at the Obesity Clinic for 4 weeks. Participants will record daily food intake and behavioral variables related to eating episodes, including hunger, satiety, emotional state, eating context, eating speed, perceived control, and cravings.

Healthcare professionals may review the NutriTrack clinical panel as supportive information. The application output will not replace clinical judgment, will not trigger automated clinical decisions, will not modify usual care, and will not be integrated into the hospital electronic health record during the pilot phase.

The study will assess usability, nutritional estimation accuracy, adherence to food logging, professional perceived clinical utility, exploratory changes in emotional regulation and eating behavior, and technical feasibility of data export. The study is intended to generate preliminary evidence to support future larger-scale validation.

Tipo de estudo

Observacional

Inscrição (Estimado)

50

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

Locais de estudo

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

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Adult patients with obesity or overweight with comorbidities who are in active follow-up at the Obesity Clinic of Hospital Clínico San Carlos and who have regular access to and use of a smartphone with iOS or Android operating system.

Descrição

Inclusion Criteria:

  • Age 18 years or older.
  • Diagnosis of obesity, defined as body mass index 30 kg/m2 or higher, or overweight with comorbidities, defined as body mass index 27 kg/m2 or higher.
  • Active follow-up at the Obesity Clinic of Hospital Clínico San Carlos.
  • Regular possession and use of a smartphone with iOS or Android operating system.
  • Ability to read and understand Spanish.
  • Signed informed consent.

Exclusion Criteria:

  • Active diagnosed eating disorder, including anorexia nervosa, bulimia nervosa, or binge eating disorder.
  • Cognitive impairment preventing autonomous use of the application.
  • Simultaneous participation in another nutritional intervention study.
  • Inability or refusal to use mobile technology.
  • Current pregnancy or breastfeeding.
  • Acute medical condition requiring hospitalization during the study period.

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

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
NutriTrack Observational Cohort
Adult patients with obesity or overweight with comorbidities followed at the Obesity Clinic of Hospital Clínico San Carlos who will use the NutriTrack application for 4 weeks as a complementary nutritional and behavioral tracking tool.
NutriTrack is a digital health application used for nutritional and behavioral tracking. Patients record food intake using food photographs, barcode scanning, or manual search, and report behavioral variables such as hunger, satiety, emotional state, eating context, eating speed, perceived control, and cravings. The application output is informational, requires healthcare professional supervision, and does not replace clinical judgment or modify usual care.
Outros nomes:
  • NutriTrack

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
System Usability Scale score
Prazo: Week 4
Usability of the NutriTrack application measured using the System Usability Scale. The score ranges from 0 to 100, with higher scores indicating better usability. A score of 70 or higher will be considered acceptable.
Week 4

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Correlation between AI-based caloric estimation and dietitian assessment
Prazo: Week 4
Correlation between caloric estimation obtained using NutriTrack artificial intelligence-based food image recognition and standard dietitian-nutritionist assessment.
Week 4
Adherence to daily food logging
Prazo: From baseline to Week 4
Percentage of days with complete food intake records during the 4-week follow-up period.
From baseline to Week 4
Healthcare professional perceived clinical utility score
Prazo: Week 4
Perceived clinical utility of NutriTrack assessed by the healthcare professional using an ad hoc questionnaire.
Week 4

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Change in Difficulties in Emotion Regulation Scale score
Prazo: Baseline to Week 4
Change in emotional regulation from baseline to Week 4 measured using the Difficulties in Emotion Regulation Scale. Higher scores indicate greater difficulties in emotion regulation.
Baseline to Week 4
Change in Eating Disorder Examination Questionnaire score
Prazo: Baseline to Week 4
Change in eating behavior from baseline to Week 4 measured using the Eating Disorder Examination Questionnaire. Higher scores indicate greater severity of eating disorder-related psychopathology.
Baseline to Week 4
Digital competence score
Prazo: Baseline
Baseline digital competence assessed using the DigComp-ES questionnaire. The score will be explored as a potential factor associated with usability of the NutriTrack application.
Baseline
Frequency and type of rule-based eating risk patterns detected by NutriTrack
Prazo: From baseline to Week 4
Frequency and type of eating risk patterns detected by the NutriTrack rule-based engine during the 4-week follow-up period. Patterns may include emotional eating, rapid eating, night eating, repeated meal omission, and possible binge-eating episodes. These alerts are informational and visible only to healthcare professionals.
From baseline to Week 4
Technical feasibility of HL7 FHIR R4 data export
Prazo: Week 4
Qualitative assessment of the technical feasibility of exporting NutriTrack study data using the HL7 FHIR R4 format for research data archiving. The export will not be used for clinical integration with the hospital electronic health record during the pilot study.
Week 4

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Francisco José García González, PhD, RN, Hospital Clínico San Carlos / Universidad Complutense de Madrid

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

  • Ministerio de Sanidad. Base de Datos Española de Composición de Alimentos (BEDCA). 2023.
  • Gratz KL, Roemer L. Multidimensional assessment of emotion regulation and dysregulation. Journal of Psychopathology and Behavioral Assessment. 2004;26(1):41-54.
  • Fairburn CG, Beglin SJ. Eating Disorder Examination Questionnaire (EDE-Q 6.0). Guilford Press; 2008.
  • Brooke J. SUS: A quick and dirty usability scale. Usability Evaluation In Industry. 1996;189(194):4-7.

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 (Estimado)

15 de junho de 2026

Conclusão Primária (Estimado)

15 de julho de 2026

Conclusão do estudo (Estimado)

30 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

6 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de maio de 2026

Primeira postagem (Real)

15 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

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

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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