Clinical Effectiveness of MyNutriKidney®
- Conditions
- Chronic Kidney Disease Stage 3Chronic Kidney DiseaseChronic Kidney Disease Stage 5Chronic Kidney Disease Stage 4
- Registration Number
- NCT06956872
- Lead Sponsor
- Universiti Putra Malaysia
- Brief Summary
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.
- Detailed Description
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:
1. 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)
2. 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)
3. 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).
4. 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)
5. 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)
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
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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)
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Aged 18 years or older.
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Possesses a personal smartphone compatible with the MyNutriKidney® application and is willing to use the health app if randomized to the intervention group.
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Alert and oriented, and deemed capable of providing informed consent and participating in study procedures.
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Able to communicate and understand study procedures in English, Bahasa Melayu, or Mandarin.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Dietary Adherence Score 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 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).
- Secondary Outcome Measures
Name Time Method Change in Serum Phosphorus Level Change from Baseline (Month 0) to 6 Months (Month 6). 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 in Serum Sodium Level Change from Baseline (Month 0) to 6 Months (Month 6). 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 in Corrected Serum Calcium Level Change from Baseline (Month 0) to 6 Months (Month 6). 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 in Dietary Knowledge Score Change from Baseline (Month 0) to 6 Months (Month 6). 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) Change from Baseline (Month 0) to 6 Months (Month 6) 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 Change from Baseline (Month 0) to 6 Months (Month 6). Serum Albumin level extracted from routine clinical laboratory results. Units measured according to local laboratory standards (e.g., g/L).
Change in Hemoglobin Level Change from Baseline (Month 0) to 6 Months (Month 6). Hemoglobin level extracted from routine clinical laboratory results. Units measured according to local laboratory standards (e.g., g/dL).
Change in Serum Potassium Level Change from Baseline (Month 0) to 6 Months (Month 6). 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.
Trial Locations
- Locations (1)
Sultan Idris Shah Hospital, Serdang
🇲🇾Kajang, Selangor, Malaysia