- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07829991
Development of a Precision Nutrition Expert System Combining AI Dietary Image Recognition and Big Data Analysis: A Case Study on Kidney Disease (CKDCare)
The goal of this interventional study is to evaluate a smartphone-based precision nutrition system for patients with chronic kidney disease (CKD).
The main questions it aims to answer are:
- Do patients with CKD find the CKDCare system easy to use?
- Does using the system change patients' dietary intake, including the proportion of ultra-processed foods they consume?
The system, called CKDCare, runs inside the LINE messaging app. It uses artificial intelligence to recognize food from photos, a chatbot to answer everyday diet questions, and a back-end dashboard that lets dietitians review each person's dietary records.
Participants will:
- Use the CKDCare system in the LINE app for three months
- Take photos of their meals and record what they eat
- Complete a questionnaire about how easy the system is to use
Have their routine clinic blood test results and nutritional assessment reviewed as part of their usual care.
Some participants will also take part in a short interview about their experience. Dietitians and physicians who care for CKD patients will use the back-end management system and give feedback on it.
Studienübersicht
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Taichung, Taiwan, 40447
- China Medical University Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
CKD patients:
- Aged 20 years or older
- Physician-diagnosed chronic kidney disease
- Available dietary records from the outpatient nutrition clinic
Healthcare professionals:
- Clinical dietitian certified in CKD nutrition, CKD outpatient dietitian, or nephrologist
Exclusion Criteria:
- Younger than 20 years of age
- No available dietary records from the outpatient nutrition clinic
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: CKD patients
Adults aged 20 years or older with a physician-diagnosed chronic kidney disease, recruited from the outpatient nutrition clinic. Participants used the CKDCare LINE chatbot to record their meals and receive personalized dietary advice for three months. |
Participants will use the CKDCare system, a dietitian-led LINE chatbot integrating dietary self-monitoring, personalized nutrition feedback, and nutrition education for CKD self-management. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
System Usability Scale (SUS) score
Zeitfenster: At 3 months (end of the system trial period)
|
Usability of the CKDCare system measured by the 10-item System Usability Scale. Total score ranges from 0 to 100, with higher scores indicating better perceived usability. |
At 3 months (end of the system trial period)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Estimated glomerular filtration rate (eGFR)
Zeitfenster: Baseline and after the intervention (at 3 months)
|
Estimated glomerular filtration rate (eGFR) will be obtained from routine clinical laboratory records and expressed in mL/min/1.73 m². Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Blood urea nitrogen (BUN)
Zeitfenster: Baseline and after the intervention (at 3 months)
|
Blood urea nitrogen (BUN) will be obtained from routine clinical laboratory records and expressed in mg/dL. Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Serum creatinine
Zeitfenster: Baseline and after the intervention (at 3 months)
|
Serum creatinine will be obtained from routine clinical laboratory records and expressed in mg/dL. Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Serum albumin
Zeitfenster: Baseline and after the intervention (at 3 months)
|
Serum albumin will be obtained from routine clinical laboratory records and expressed in g/dL. Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Serum potassium
Zeitfenster: Baseline and after the intervention (at 3 months)
|
Serum potassium will be obtained from routine clinical laboratory records and expressed in mmol/L. Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Serum phosphorus
Zeitfenster: Baseline and after the intervention (at 3 months)
|
Serum phosphorus will be obtained from routine clinical laboratory records and expressed in mg/dL. Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Hemoglobin (Hb)
Zeitfenster: Baseline and after the intervention (at 3 months)
|
Hemoglobin will be obtained from routine clinical laboratory records and expressed in g/dL. Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Daily energy intake
Zeitfenster: Baseline and after the intervention (at 3 months)
|
Daily energy intake will be assessed using dietary records and expressed in kilocalories per day (kcal/day). Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Daily protein intake
Zeitfenster: Baseline and after the intervention (at 3 months)
|
Daily protein intake will be assessed using dietary records and expressed in grams per day (g/day). Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Daily sodium intake
Zeitfenster: Baseline and after the intervention (at 3 months)
|
Daily sodium intake will be assessed using dietary records and expressed in milligrams per day (mg/day). Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Daily potassium intake
Zeitfenster: Baseline and after the intervention (at 3 months)
|
Daily potassium intake will be assessed using dietary records and expressed in milligrams per day (mg/day). Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Daily phosphorus intake
Zeitfenster: Baseline and after the intervention (at 3 months)
|
Daily phosphorus intake will be assessed using dietary records and expressed in milligrams per day (mg/day). Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Subjective Global Assessment (SGA)
Zeitfenster: Baseline and after the intervention (at 3 months)
|
Nutritional status will be assessed by a dietitian using the Subjective Global Assessment (SGA), classified as well nourished (A), moderately malnourished (B), or severely malnourished (C). Changes in nutritional status from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Proportion of ultra-processed food intake
Zeitfenster: Baseline and after the intervention (at 3 months)
|
The proportion of ultra-processed food intake will be assessed using the NOVA food classification system. Kidney disease-specific therapeutic nutritional supplements will be excluded from the calculation. Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Pathologische Prozesse
- Männliche Urogenitalerkrankungen
- Nierenerkrankungen
- Urologische Erkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Chronische Erkrankung
- Krankheitsattribute
- Niereninsuffizienz
- Pathologische Zustände, Anzeichen und Symptome
- Niereninsuffizienz, chronisch
Andere Studien-ID-Nummern
- CMUH114-REC1-021
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .