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

6 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

50

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Autre: NutriTrack digital health application
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.
Autres noms:
  • NutriTrack

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
System Usability Scale score
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Correlation between AI-based caloric estimation and dietitian assessment
Délai: 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
Délai: 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
Délai: Week 4
Perceived clinical utility of NutriTrack assessed by the healthcare professional using an ad hoc questionnaire.
Week 4

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Change in Difficulties in Emotion Regulation Scale score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Francisco José García González

Collaborateurs

Hospital San Carlos, Madrid

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

  • 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.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 juin 2026

Achèvement primaire (Estimé)

15 juillet 2026

Achèvement de l'étude (Estimé)

30 septembre 2026

Dates d'inscription aux études

Première soumission

6 mai 2026

Première soumission répondant aux critères de contrôle qualité

6 mai 2026

Première publication (Réel)

15 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NUTRITRACK-CEI-HCSC-2026-001

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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