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NCT Number: NCT06956872

Clinical Effectiveness of MyNutriKidney®

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.

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Key information

Conditions

Chronic Kidney Disease Stage 3 Chronic Disease Chronic Kidney Disease Chronic Kidney Disease Stage 4 Chronic Kidney Disease Stage 5 Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultan Idris Shah Hospital, Serdang

Kajang, Selangor, 43000, Malaysia

Location contact

Nor Fadhlina binti Zakaria, Nephrologist

CONTACT

[email protected]

+60-389472561

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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).

Treatment and study plan

Counseling

Other

Subjects in the both arms will receive individualized dietetic counseling as the standard dietetic care in Malaysia

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.

Other names: MyNutriKidney

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.

Primary outcomes

  1. Change in Dietary Adherence Score

    Time frame: 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).

  2. Change in Nutrition Literacy Score

    Time frame: 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 outcomes

  1. Change in Dietary Knowledge Score

    Time frame: 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

  2. Change in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: 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.

  3. Change in Serum Albumin Level

    Time frame: 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).

  4. Change in Hemoglobin Level

    Time frame: 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).

  5. Change in Serum Potassium Level

    Time frame: 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.

  6. Change in Serum Phosphorus Level

    Time frame: 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.

  7. Change in Serum Sodium Level

    Time frame: 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.

  8. Change in Corrected Serum Calcium Level

    Time frame: 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.

Other outcomes

  1. App Usability and Satisfaction Score

    Time frame: Assessed at 6 Months (Month 6).

    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).

  2. Average Weekly Meal Logging Frequency

    Time frame: Calculated as an average over the period from Baseline (Month 0) to 6 Months (Month 6).

    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).

  3. Average Weekly Time on Educational Modules

    Time frame: Calculated as an average over the period from Baseline (Month 0) to 6 Months (Month 6).

    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).

  4. Total Number of Gamification Challenges Completed

    Time frame: Calculated as a total over the period from Baseline (Month 0) to 6 Months (Month 6).

    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).

  5. Interaction Rate with Actionable Reminders

    Time frame: Calculated over the period from Baseline (Month 0) to 6 Months (Month 6)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Leong Sim Kian, Dietitian

CONTACT

+60-172946309

Zulfitri 'Azuan bin Mat Daud, Dietitian Lecturer [Dr]

CONTACT

[email protected]

+60-397692431

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Collaborators

  • International Society of Nephrology

Registry information

Official study title

Clinical Effectiveness of MyNutriKidney® for Dietary Self-management in Chronic Kidney Disease Patients: Protocol for a Pragmatic Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 4, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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