- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Taichung, Taiwan, 40447
- China Medical University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
System Usability Scale (SUS) score
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Estimated glomerular filtration rate (eGFR)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Patologiske prosesser
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Kronisk sykdom
- Sykdomsattributter
- Nyreinsuffisiens
- Patologiske tilstander, tegn og symptomer
- Nyresvikt, kronisk
Andre studie-ID-numre
- CMUH114-REC1-021
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