NCT07588620

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

May 6, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

Digital healthArtificial intelligenceNutritional trackingFood recognitionMobile healthEating behaviorUsability

Outcome Measures

Primary Outcomes (1)

  • System Usability Scale score

    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

Secondary Outcomes (3)

  • Correlation between AI-based caloric estimation and dietitian assessment

    Week 4

  • Adherence to daily food logging

    From baseline to Week 4

  • Healthcare professional perceived clinical utility score

    Week 4

Other Outcomes (5)

  • Change in Difficulties in Emotion Regulation Scale score

    Baseline to Week 4

  • Change in Eating Disorder Examination Questionnaire score

    Baseline to Week 4

  • Digital competence score

    Baseline

  • +2 more other outcomes

Study Arms (1)

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.

Other: NutriTrack digital health application

Interventions

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.

Also known as: NutriTrack
NutriTrack Observational Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Related Publications (4)

  • Ministerio de Sanidad. Base de Datos Española de Composición de Alimentos (BEDCA). 2023.

    BACKGROUND
  • Gratz KL, Roemer L. Multidimensional assessment of emotion regulation and dysregulation. Journal of Psychopathology and Behavioral Assessment. 2004;26(1):41-54.

    BACKGROUND
  • Fairburn CG, Beglin SJ. Eating Disorder Examination Questionnaire (EDE-Q 6.0). Guilford Press; 2008.

    BACKGROUND
  • Brooke J. SUS: A quick and dirty usability scale. Usability Evaluation In Industry. 1996;189(194):4-7.

    BACKGROUND

MeSH Terms

Conditions

ObesityOverweightFeeding Behavior

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Officials

  • Francisco José García González, PhD, RN

    Hospital Clínico San Carlos / Universidad Complutense de Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco José García González, PhD, RN

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator; CEPs Coordinator

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 15, 2026

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations