Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07588620

NutriTrack: AI-Assisted Nutritional Tracking in the Obesity Clinic

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Obesity & Overweight Behavior Behavior, Animal Body Weight Feeding Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NutriTrack digital health application

Other

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.

Other names: NutriTrack

Primary outcomes

  1. System Usability Scale score

    Time frame: 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.

Secondary outcomes

  1. Correlation between AI-based caloric estimation and dietitian assessment

    Time frame: Week 4

    Correlation between caloric estimation obtained using NutriTrack artificial intelligence-based food image recognition and standard dietitian-nutritionist assessment.

  2. Adherence to daily food logging

    Time frame: From baseline to Week 4

    Percentage of days with complete food intake records during the 4-week follow-up period.

  3. Healthcare professional perceived clinical utility score

    Time frame: Week 4

    Perceived clinical utility of NutriTrack assessed by the healthcare professional using an ad hoc questionnaire.

Other outcomes

  1. Change in Difficulties in Emotion Regulation Scale score

    Time frame: 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.

  2. Change in Eating Disorder Examination Questionnaire score

    Time frame: 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.

  3. Digital competence score

    Time frame: 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.

  4. Frequency and type of rule-based eating risk patterns detected by NutriTrack

    Time frame: 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.

  5. Technical feasibility of HL7 FHIR R4 data export

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Francisco José García González, PhD, RN

CONTACT

[email protected]

+34657675111

Sponsors and collaborators

Lead sponsor

Francisco José García González

Other

Collaborators

  • Hospital San Carlos, Madrid

Registry information

Official study title

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

Acronym: NUTRITRACK

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.