NutriTrack: An Artificial Intelligence Application for Nutritional and Behavioral Tracking in Patients With Obesity in an Outpatient Obesity Clinic: A Prospective Observational Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- System Usability Scale score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: NutriTrack digital health application (Other)
结局指标
主要结局
System Usability Scale score
时间窗: 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.
次要结局
- 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)
研究者
Francisco José García González
Principal Investigator; CEPs Coordinator
Universidad Complutense de Madrid