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Development of a Precision Nutrition Expert System Combining AI Dietary Image Recognition and Big Data Analysis: A Case Study on Kidney Disease (CKDCare)

2026年10月20日 更新者:China Medical University Hospital

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:

  1. Do patients with CKD find the CKDCare system easy to use?
  2. 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:

  1. Use the CKDCare system in the LINE app for three months
  2. Take photos of their meals and record what they eat
  3. 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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Taichung、台湾、40447
        • China Medical University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
System Usability Scale (SUS) score
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Estimated glomerular filtration rate (eGFR)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月25日

初级完成 (实际的)

2026年9月23日

研究完成 (实际的)

2026年9月23日

研究注册日期

首次提交

2026年9月13日

首先提交符合 QC 标准的

2026年9月17日

首次发布 (实际的)

2026年9月21日

研究记录更新

最后更新发布 (实际的)

2026年10月21日

上次提交的符合 QC 标准的更新

2026年10月20日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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