Clinical Effectiveness of MyNutriKidney®

May 1, 2025 updated by: Kent Leong Sim Kian, Universiti Putra Malaysia

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zulfitri 'Azuan bin Mat Daud, Dietitian Lecturer [Dr]
  • Phone Number: +60-397692431
  • Email: zulfitri@upm.edu.my

Study Contact Backup

  • Name: Leong Sim Kian, Dietitian
  • Phone Number: +60-172946309

Study Locations

  • Malaysia
    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • Sultan Idris Shah Hospital, Serdang
        • Contact:
          • Nor Fadhlina binti Zakaria, Nephrologist
          • Phone Number: +60-389472561
          • Email: fadhsara@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  1. 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)

  2. Aged 18 years or older.
  3. Possesses a personal smartphone compatible with the MyNutriKidney® application and is willing to use the health app if randomized to the intervention group.
  4. Alert and oriented, and deemed capable of providing informed consent and participating in study procedures.
  5. Able to communicate and understand study procedures in English, Bahasa Melayu, or Mandarin.

Exclusion Criteria:

  1. Inability to effectively use the smartphone application due to significant impairments (e.g., severe visual or motor problems).
  2. Smartphone owned by the participant does not meet the minimum technical requirements for the MyNutriKidney® application installation and operation
  3. 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.
  4. Known unwillingness or inability to comply with core study procedures, including dietary assessment components.
  5. Concurrent participation in another interventional research study.
  6. Participation in another research study involving an investigational product in the 12 weeks preceding potential enrollment.
  7. Female participants who are pregnant, currently lactating, or planning a pregnancy during the course of the trial.
  8. Currently receiving primary nutritional support via enteral tube feeding or parenteral (intra-venous) nutrition.
  9. Currently receiving active treatment for cancer (e.g., chemotherapy, radiotherapy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Counseling
Subjects in the both arms will receive individualized dietetic counseling as the standard dietetic care in Malaysia
Other: Renal Diet App
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
Placebo Comparator: 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.
Other: Counseling
Subjects in the both arms will receive individualized dietetic counseling as the standard dietetic care in Malaysia
Other: Printed Nutrition Pamphlet
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from Baseline (Month 0) to 6 Months (Month 6).
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).
Change from Baseline (Month 0) to 6 Months (Month 6).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from Baseline (Month 0) to 6 Months (Month 6).
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.
Change from Baseline (Month 0) to 6 Months (Month 6)
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).
Change from Baseline (Month 0) to 6 Months (Month 6).
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).
Change from Baseline (Month 0) to 6 Months (Month 6).
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.
Change from Baseline (Month 0) to 6 Months (Month 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.
Change from Baseline (Month 0) to 6 Months (Month 6).
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.
Change from Baseline (Month 0) to 6 Months (Month 6).
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.
Change from Baseline (Month 0) to 6 Months (Month 6).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Assessed at 6 Months (Month 6).
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).
Calculated as an average over the period from Baseline (Month 0) to 6 Months (Month 6).
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).
Calculated as an average over the period from Baseline (Month 0) to 6 Months (Month 6).
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).
Calculated as a total over the period from Baseline (Month 0) to 6 Months (Month 6).
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).
Calculated over the period from Baseline (Month 0) to 6 Months (Month 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Putra Malaysia

Collaborators

International Society of Nephrology

Investigators

  • Principal Investigator: Nor Fadhlina binti Zakaria, Nephrologist, Universiti Putra Malaysia
  • Principal Investigator: Barakatun Nisak binti Mohd Yusof, Dietitian Professor [Dr], Universiti Putra Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 23, 2025

First Submitted That Met QC Criteria

May 1, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

May 1, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRR-19-3569-50972A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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