- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Taichung, 대만, 40447
- China Medical University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
System Usability Scale (SUS) score
기간: 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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Estimated glomerular filtration rate (eGFR)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CMUH114-REC1-021
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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