NutriTrack: AI-Assisted Nutritional Tracking in the Obesity Clinic (NUTRITRACK)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Francisco José García González, PhD, RN
- 전화번호: +34657675111
- 이메일: franciscojose.garcia@salud.madrid.org
연구 장소
-
-
Madrid
-
Madrid, Madrid, 스페인, 28040
- Hospital Clinico San Carlos
-
연락하다:
- Francisco José García González, PhD, RN
- 전화번호: +34 657675111
- 이메일: franciscojose.garcia@salud.madrid.org
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
System Usability Scale score
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Correlation between AI-based caloric estimation and dietitian assessment
기간: 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
기간: 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
기간: Week 4
|
Perceived clinical utility of NutriTrack assessed by the healthcare professional using an ad hoc questionnaire.
|
Week 4
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Difficulties in Emotion Regulation Scale score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Francisco José García González, PhD, RN, Hospital Clínico San Carlos / Universidad Complutense de Madrid
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- NUTRITRACK-CEI-HCSC-2026-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
NutriTrack digital health application에 대한 임상 시험
-
St. George's Hospital, London아직 모집하지 않음
-
Columbia UniversityNational Institute of Nursing Research (NINR)완전한
-
CoheroHealthLindus Health; Aptar Digital Health완전한
-
Milton S. Hershey Medical CenterPenn State University; Congressionally Directed Medical Research Programs모집하지 않고 적극적으로