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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Francisco José García González, PhD, RN
- 电话号码：+34657675111
- 邮箱：franciscojose.garcia@salud.madrid.org
学习地点
-
-
Madrid
-
Madrid、Madrid、西班牙、28040
- Hospital Clinico San Carlos
-
接触：
- Francisco José García González, PhD, RN
- 电话号码：+34 657675111
- 邮箱：franciscojose.garcia@salud.madrid.org
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
System Usability Scale score
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation between AI-based caloric estimation and dietitian assessment
大体时间：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
大体时间：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
大体时间：Week 4
|
Perceived clinical utility of NutriTrack assessed by the healthcare professional using an ad hoc questionnaire.
|
Week 4
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Difficulties in Emotion Regulation Scale score
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
调查人员
- 首席研究员：Francisco José García González, PhD, RN、Hospital Clínico San Carlos / Universidad Complutense de Madrid
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.