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.
Обзор исследования
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
-
Taichung, Тайвань, 40447
- China Medical University Hospital
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
System Usability Scale (SUS) score
Временное ограничение: 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)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Estimated glomerular filtration rate (eGFR)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Патологические процессы
- Мужские мочеполовые заболевания
- Заболевания почек
- Урологические заболевания
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Хроническое заболевание
- Атрибуты болезни
- Почечная недостаточность
- Патологические состояния, признаки и симптомы
- Почечная недостаточность, хроническая
Другие идентификационные номера исследования
- CMUH114-REC1-021
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .