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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Francisco José García González, PhD, RN
- 電話番号：+34657675111
- メール：franciscojose.garcia@salud.madrid.org
研究場所
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Madrid
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Madrid、Madrid、スペイン、28040
- Hospital Clinico San Carlos
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コンタクト：
- Francisco José García González, PhD, RN
- 電話番号：+34 657675111
- メール：franciscojose.garcia@salud.madrid.org
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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System Usability Scale score
時間枠：Week 4
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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.
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Week 4
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Correlation between AI-based caloric estimation and dietitian assessment
時間枠：Week 4
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Correlation between caloric estimation obtained using NutriTrack artificial intelligence-based food image recognition and standard dietitian-nutritionist assessment.
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Week 4
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Adherence to daily food logging
時間枠：From baseline to Week 4
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Percentage of days with complete food intake records during the 4-week follow-up period.
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From baseline to Week 4
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Healthcare professional perceived clinical utility score
時間枠：Week 4
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Perceived clinical utility of NutriTrack assessed by the healthcare professional using an ad hoc questionnaire.
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Week 4
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Change in Difficulties in Emotion Regulation Scale score
時間枠：Baseline to Week 4
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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.
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Baseline to Week 4
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Change in Eating Disorder Examination Questionnaire score
時間枠：Baseline to Week 4
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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.
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Baseline to Week 4
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Digital competence score
時間枠：Baseline
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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.
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Baseline
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Frequency and type of rule-based eating risk patterns detected by NutriTrack
時間枠：From baseline to Week 4
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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.
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From baseline to Week 4
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Technical feasibility of HL7 FHIR R4 data export
時間枠：Week 4
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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.
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Week 4
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協力者と研究者
捜査官
- 主任研究者：Francisco José García González, PhD, RN、Hospital Clínico San Carlos / Universidad Complutense de Madrid
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- NUTRITRACK-CEI-HCSC-2026-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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NutriTrack digital health applicationの臨床試験
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St. George's Hospital, Londonまだ募集していません
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Memorial Sloan Kettering Cancer CenterUniversity of Pennsylvania; University of California, Los Angeles; Dana-Farber Cancer Institute; Beth Israel Deaconess Medical Center と他の協力者積極的、募集していない
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CoheroHealthLindus Health; Aptar Digital Health完了
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Milton S. Hershey Medical CenterPenn State University; Congressionally Directed Medical Research Programs積極的、募集していない