Clinical Effectiveness of MyNutriKidney® for Dietary Self-management in Chronic Kidney Disease Patients: Protocol for a Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Dietary Adherence Score
研究概览
简要总结
This study is a 6-month, pragmatic, multi-center, sequentially recruited, stratified, open-label randomized controlled trial (RCT) conducted in Malaysia. It aims to determine the clinical effectiveness of a culturally adapted, gamified mobile health app (MyNutriKidney®) supplementing standard care, compared to standard care alone, for improving dietary self-management among 200 adults with Chronic Kidney Disease (CKD) stages 3-5. Participants will be randomly assigned (1:1, stratified by age and education) into either (i) the intervention group (MyNutriKidney® app + standard care) or (ii) the control group (standard care, including routine dietary counseling and printed materials). The co-primary outcomes are changes in Dietary Adherence (measured by CKD Diet Score) and Nutrition Literacy (measured by NLS score) from baseline to 6 months.
详细描述
General Objective:
To evaluate the clinical effectiveness of supplementing standard care with the MyNutriKidney® mobile application compared to standard care alone in improving dietary adherence and nutrition literacy among patients with Chronic Kidney Disease (CKD) stages 3-5 in Malaysia over a 6-month period.
Specific Objectives:
- To compare the change in Dietary Adherence (DA), assessed by the CKD Diet Score (derived from 3x 24-hour dietary recalls), from baseline to 6 months between the MyNutriKidney® intervention group and the standard care control group. (Co-primary objective)
- To compare the change in Nutrition Literacy (NL), assessed by the Nutrition Literacy Scale (NLS) score, from baseline to 6 months between the intervention and control groups. (Co-primary objective)
- To compare the changes in secondary outcomes from baseline to 6 months between the two groups, including:
3.1. Dietary Knowledge, assessed by the Dietary Knowledge Questionnaire (DKQ) score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following inclusion criteria and none of the
排除标准
- •to be eligible for enrolment into the study.
- •Inclusion Criteria:
- •Clinically diagnosed Chronic Kidney Disease (CKD):
- •eGFR < 60 ml/min/1.73m² for ≥ 3 months (applicable to pre-dialysis patients, Stages 3-5)
- •Aged 18 years or older.
- •Possesses a personal smartphone compatible with the MyNutriKidney® application and is willing to use the health app if randomized to the intervention group.
- •Alert and oriented, and deemed capable of providing informed consent and participating in study procedures.
- •Able to communicate and understand study procedures in English, Bahasa Melayu, or Mandarin.
- •Exclusion Criteria:
- •Inability to effectively use the smartphone application due to significant impairments (e.g., severe visual or motor problems).
- •Smartphone owned by the participant does not meet the minimum technical requirements for the MyNutriKidney® application installation and operation
- •Presence of significant cognitive impairment or severe psychological conditions (e.g., uncontrolled anxiety or depression) likely to impede consistent participation or adherence to study requirements.
- •Known unwillingness or inability to comply with core study procedures, including dietary assessment components.
- •Concurrent participation in another interventional research study.
- •Participation in another research study involving an investigational product in the 12 weeks preceding potential enrollment.
- •Female participants who are pregnant, currently lactating, or planning a pregnancy during the course of the trial.
- •Currently receiving primary nutritional support via enteral tube feeding or parenteral (intra-venous) nutrition.
- •Currently receiving active treatment for cancer (e.g., chemotherapy, radiotherapy).
研究组 & 干预措施
Standard Care + Renal Diet App
Participants receive usual standard care for CKD stages 3-5, supplemented with the use of the MyNutriKidney® mobile application for a 6-month period. Following onboarding and training, participants utilize the app for daily manual meal logging, receive automated nutrient estimations and real-time feedback against personalized dietary recommendations (utilizing a Malaysian food database), access tailored educational modules, engage with gamification features (challenges, progress tracking), and receive periodic personalized feedback from study dietitians via in-app messaging or virtual consultations. Technical support is available.
干预措施: Counseling (Other)
Standard Care + Renal Diet App
Participants receive usual standard care for CKD stages 3-5, supplemented with the use of the MyNutriKidney® mobile application for a 6-month period. Following onboarding and training, participants utilize the app for daily manual meal logging, receive automated nutrient estimations and real-time feedback against personalized dietary recommendations (utilizing a Malaysian food database), access tailored educational modules, engage with gamification features (challenges, progress tracking), and receive periodic personalized feedback from study dietitians via in-app messaging or virtual consultations. Technical support is available.
干预措施: Renal Diet App (Other)
Standard Care
Participants receive usual standard care for CKD stages 3-5 as provided at the participating clinics for a 6-month period. This typically includes face-to-face dietary counseling sessions with a clinic dietitian scheduled based on clinical need (e.g., every 1-3 months), provision of standard printed educational materials and general CKD dietary guidelines, and routine clinical and laboratory monitoring by their usual healthcare providers. Participants in this group do not receive access to the MyNutriKidney® app during the study.
干预措施: Counseling (Other)
Standard Care
Participants receive usual standard care for CKD stages 3-5 as provided at the participating clinics for a 6-month period. This typically includes face-to-face dietary counseling sessions with a clinic dietitian scheduled based on clinical need (e.g., every 1-3 months), provision of standard printed educational materials and general CKD dietary guidelines, and routine clinical and laboratory monitoring by their usual healthcare providers. Participants in this group do not receive access to the MyNutriKidney® app during the study.
干预措施: Printed Nutrition Pamphlet (Other)
结局指标
主要结局
Change in Dietary Adherence Score
时间窗: Change from Baseline (Month 0) to 6 Months (Month 6).
Dietary Adherence (DA) quantified using CKD Diet Score (adapted from GCKD study). Intake data from 3x 24-hour dietary recalls (dietitian interview) per assessment (Baseline, M3, M6). Nutrient intake analyzed. Score derived from 6 components: sodium, potassium, fiber, total protein, sugar, cholesterol. Intake adjusted per 1000 kcal; points 1 (poor) to 5 (high adherence) assigned based on thresholds. Sodium and total protein scores weighted x1.5. Total Score = (Sodium Score 1.5) + Potassium Score + Fiber Score + (Protein Score 1.5) + Sugar Score + Cholesterol Score. Total score range: 7 (poorest adherence) to 35 (highest adherence).
Change in Nutrition Literacy Score
时间窗: Change from Baseline (Month 0) to 6 Months (Month 6).
Nutrition Literacy assessed using the Nutrition Literacy Scale (NLS) score (validated Malay version). The standardized index score ranges from 0 (lowest literacy) to 100 (highest literacy).
次要结局
- Change in Dietary Knowledge Score(Change from Baseline (Month 0) to 6 Months (Month 6).)
- Change in Estimated Glomerular Filtration Rate (eGFR)(Change from Baseline (Month 0) to 6 Months (Month 6))
- Change in Serum Albumin Level(Change from Baseline (Month 0) to 6 Months (Month 6).)
- Change in Hemoglobin Level(Change from Baseline (Month 0) to 6 Months (Month 6).)
- Change in Serum Potassium Level(Change from Baseline (Month 0) to 6 Months (Month 6).)
- Change in Serum Phosphorus Level(Change from Baseline (Month 0) to 6 Months (Month 6).)
- Change in Serum Sodium Level(Change from Baseline (Month 0) to 6 Months (Month 6).)
- Change in Corrected Serum Calcium Level(Change from Baseline (Month 0) to 6 Months (Month 6).)
研究者
Kent Leong Sim Kian
Principle Investigator [Dietitian]
Universiti Putra Malaysia