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.
None
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.
Parallel
Counseling
Other interventionSubjects in the both arms will receive individualized dietetic counseling as the standard dietetic care in Malaysia
Renal Diet App
Other interventionIndividualized dietetic counseling aided with a newly developed renal diet app for educative purpose and aiding tool to enhance the dietary adherence among CKD patients. Training on the use of the app will be provided to the subjects prior to the commencement of the intervention. Subjects will be trained on the use of the home screen, icons, feedback screens, the process of entering dietary and fluid intake data and selecting portion sizes. Subjects are considered as competent users when they could correctly record the foods and drinks with correct portion size eaten in the past 24 hours and successfully save the data.
Printed Nutrition Pamphlet
Other interventionAfter the counseling session, a standardized renal nutrition pamphlet prepared by dietitians from Universiti Putra Malaysia and Hospital Serdang will be given for patient's educative purpose. Since the mobile application is intended for patient's education and self-monitoring (food diary) purposes, and thus, to ensure the comparability between intervention and control groups, the patients in control group will be trained to record their diet intakes manually using the recommended approach 3-day diet records. Nutritional feedback or advices on the diet records will be given to the participants during follow up sessions.
Change in Dietary Adherence Score
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
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).
Change in Dietary Knowledge Score
Dietary Knowledge assessed using the Dietary Knowledge Questionnaire (DKQ) score (25 items). Score is expressed as a percentage (0-100%), with higher scores indicating greater knowledge
Change in Estimated Glomerular Filtration Rate (eGFR)
eGFR calculated using the CKD-EPI formula based on serum creatinine levels extracted from routine clinical laboratory results. Measured in mL/min/1.73 m².
Change in Serum Albumin Level
Serum Albumin level extracted from routine clinical laboratory results. Units measured according to local laboratory standards (e.g., g/L).
Change in Hemoglobin Level
Hemoglobin level extracted from routine clinical laboratory results. Units measured according to local laboratory standards (e.g., g/dL).
App Usability and Satisfaction Score
Assessed using the Malay version of the mHealth Application Usability Questionnaire (M-MAUQ). An overall average score is calculated based on a 7-point Likert scale (1=strongly disagree to 7=strongly agree), with higher scores indicating better usability/satisfaction. (Assessed in Intervention Group only).
Average Weekly Meal Logging Frequency
Frequency of meal logging, calculated as average logs per week, derived from passively logged user interaction data from the MyNutriKidney® app's backend analytics system. Unit: logs/week. (Assessed in Intervention Group only).
Average Weekly Time on Educational Modules
Time spent interacting with educational modules, calculated as average minutes per week, derived from passively logged user interaction data from the MyNutriKidney® app's backend analytics system. Unit: minutes/week. (Assessed in Intervention Group only).
Total Number of Gamification Challenges Completed
Completion of gamification challenges, measured as the total number completed, derived from passively logged user interaction data from the MyNutriKidney® app's backend analytics system. Unit: count. (Assessed in Intervention Group only).
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Universiti Putra Malaysia
Lead sponsor
International Society of Nephrology
Collaborator
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