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| Name | Class |
|---|---|
| International Society of Nephrology | OTHER |
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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.
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.
3.2. Kidney Function, assessed by the estimated Glomerular Filtration Rate (eGFR).
3.3. Serum Electrolyte Levels (Potassium, Phosphorus, Sodium, Calcium).
To evaluate app engagement metrics (e.g., meal logging frequency, time spent on educational resources, challenge completion) among participants in the MyNutriKidney® intervention group over the 6-month period. (Exploratory objective)
To assess participant satisfaction and usability of the MyNutriKidney® app using the Malay version of the mHealth Application Usability Questionnaire (M-MAUQ) at 6 months among participants in the intervention group. (Exploratory objective)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care + Renal Diet App | Experimental | 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. |
|
| Standard Care | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling | Other | Subjects in the both arms will receive individualized dietetic counseling as the standard dietetic care in Malaysia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 from Baseline (Month 0) to 6 Months (Month 6). |
| 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 from Baseline (Month 0) to 6 Months (Month 6). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 from Baseline (Month 0) to 6 Months (Month 6). |
| Change in Estimated Glomerular Filtration Rate (eGFR) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Assessed at 6 Months (Month 6). |
Participants must meet all of the following inclusion criteria and none of the exclusion criteria to be eligible for enrolment into the study.
Inclusion Criteria:
Clinically diagnosed Chronic Kidney Disease (CKD):
1.1. 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zulfitri 'Azuan bin Mat Daud, Dietitian Lecturer [Dr] | Contact | +60-397692431 | zulfitri@upm.edu.my | |
| Leong Sim Kian, Dietitian | Contact | +60-172946309 |
| Name | Affiliation | Role |
|---|---|---|
| Nor Fadhlina binti Zakaria, Nephrologist | Universiti Putra Malaysia | Principal Investigator |
| Barakatun Nisak binti Mohd Yusof, Dietitian Professor [Dr] | Universiti Putra Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sultan Idris Shah Hospital, Serdang | Kajang | Selangor | 43000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38553931 | Background | Thong KM, Jalalonmuhali M, Choo CL, Yee SY, Yahya R, Jeremiah PN, Bavanandan S, Hooi LS. Audit on data accuracy of the Malaysian Dialysis and Transplant Registry (MDTR). Med J Malaysia. 2024 Mar;79(2):234-236. | |
| 32795256 | Result | Saminathan TA, Hooi LS, Mohd Yusoff MF, Ong LM, Bavanandan S, Rodzlan Hasani WS, Tan EZZ, Wong I, Rifin HM, Robert TG, Ismail H, Wong NI, Ahmad G, Ambak R, Othman F, Abd Hamid HA, Aris T. Prevalence of chronic kidney disease and its associated factors in Malaysia; findings from a nationwide population-based cross-sectional study. BMC Nephrol. 2020 Aug 14;21(1):344. doi: 10.1186/s12882-020-01966-8. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| Renal Diet App | Other | Individualized 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. |
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| Printed Nutrition Pamphlet | Other | After 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. |
|
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 from Baseline (Month 0) to 6 Months (Month 6) |
| 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 from Baseline (Month 0) to 6 Months (Month 6). |
| Change in Hemoglobin Level | Hemoglobin level extracted from routine clinical laboratory results. Units measured according to local laboratory standards (e.g., g/dL). | Change from Baseline (Month 0) to 6 Months (Month 6). |
| Change in Serum Potassium Level | Serum potassium (K) level extracted from routine clinical laboratory results obtained near the study visit time points as part of standard CKD care. Unit: mmol/L. | Change from Baseline (Month 0) to 6 Months (Month 6). |
| Change in Serum Phosphorus Level | Serum phosphorus (P) level extracted from routine clinical laboratory results obtained near the study visit time points as part of standard CKD care. Unit: mmol/L. | Change from Baseline (Month 0) to 6 Months (Month 6). |
| Change in Serum Sodium Level | Serum sodium (Na) level extracted from routine clinical laboratory results obtained near the study visit time points as part of standard CKD care. Unit: mmol/L. | Change from Baseline (Month 0) to 6 Months (Month 6). |
| Change in Corrected Serum Calcium Level | Corrected serum calcium (Ca) level extracted from routine clinical laboratory results obtained near the study visit time points as part of standard CKD care. Unit: mmol/L. | Change from Baseline (Month 0) to 6 Months (Month 6). |
| 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). | Calculated as an average over the period from Baseline (Month 0) to 6 Months (Month 6). |
| 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). | Calculated as an average over the period from Baseline (Month 0) to 6 Months (Month 6). |
| 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). | Calculated as a total over the period from Baseline (Month 0) to 6 Months (Month 6). |
| Interaction Rate with Actionable Reminders | Responsiveness to notifications, measured as the interaction rate with actionable reminders, derived from passively logged user interaction data from the MyNutriKidney® app's backend analytics system. (Number of Interactions / Number of Reminders Sent) * 100%. Unit: %. (Assessed in Intervention Group only). | Calculated over the period from Baseline (Month 0) to 6 Months (Month 6) |
| 25959301 | Result | Campbell J, Porter J. Dietary mobile apps and their effect on nutritional indicators in chronic renal disease: A systematic review. Nephrology (Carlton). 2015 Oct;20(10):744-751. doi: 10.1111/nep.12500. |
| 32478665 | Result | Lim JH, Lim CK, Ibrahim I, Syahrul J, Mohamed Zabil MH, Zakaria NF, Daud ZAM. Limitations of Existing Dialysis Diet Apps in Promoting User Engagement and Patient Self-Management: Quantitative Content Analysis Study. JMIR Mhealth Uhealth. 2020 Jun 1;8(6):e13808. doi: 10.2196/13808. |
| 33066603 | Result | Lim JH, Chinna K, Khosla P, Karupaiah T, Daud ZAM. Understanding How Nutrition Literacy Links to Dietary Adherence in Patients Undergoing Maintenance Hemodialysis: A Theoretical Exploration Using Partial Least Squares Structural Equation Modeling. Int J Environ Res Public Health. 2020 Oct 14;17(20):7479. doi: 10.3390/ijerph17207479. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005159 | Health Care Facilities Workforce and Services |