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Chronic Kidney Disease Stage 3NCT06956872

Clinical Effectiveness of MyNutriKidney®

A study testing Counseling, Renal Diet App and Printed Nutrition Pamphlet in people with Chronic Kidney Disease Stage 3 and Chronic Kidney Disease, run by Universiti Putra Malaysia at 1 site in Malaysia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Counseling, Renal Diet App and Printed Nutrition Pamphlet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteMalaysia
Study dates
1 Jul 2025to 1 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

+60-397692431

zulfitri@upm.edu.my

Leong Sim Kian, Dietitian contact

+60-172946309

Malaysia1 site

  • Sultan Idris Shah Hospital, Serdang

    Kajang, Selangor, 43000

    Nor Fadhlina binti Zakaria, Nephrologist, +60-389472561, fadhsara@yahoo.com

Other trials in Malaysia

About this study

Official title: 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.

Read the 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)
Being tested
Counseling, Renal Diet App, Printed Nutrition Pamphlet
Keywords
MyNutriKidney, chronic kidney disease, CKD, Dietary Adherence, Nutrition Literacy, Self-management, Mobile Health, Dietitian, mHealth, Telemedicine, Digital Health, Malaysia, Kidney Diseases
Medical subject headings
Renal Insufficiency, Chronic, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CounselingOther

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

  • Renal Diet AppOther

    Also called MyNutriKidney

    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.

  • Printed Nutrition PamphletOther

    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.

Study groups in NCT06956872
Study groupRoleWhat they receive
Standard Care + Renal Diet AppExperimentalParticipants 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.
Receives: Other: Counseling; Other: Renal Diet App
Standard CarePlacebo comparatorParticipants 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.
Receives: Other: Counseling; Other: Printed Nutrition Pamphlet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Change from Baseline (Month 0) to 6 Months (Month 6).

  2. 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).

    Measured: Change from Baseline (Month 0) to 6 Months (Month 6).

Secondary outcomes (8)

  1. 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

    Measured: Change from Baseline (Month 0) to 6 Months (Month 6).

  2. 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.

    Measured: Change from Baseline (Month 0) to 6 Months (Month 6)

  3. 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).

    Measured: Change from Baseline (Month 0) to 6 Months (Month 6).

  4. Change in Hemoglobin Level

    Hemoglobin level extracted from routine clinical laboratory results. Units measured according to local laboratory standards (e.g., g/dL).

    Measured: Change from Baseline (Month 0) to 6 Months (Month 6).

  5. 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.

    Measured: Change from Baseline (Month 0) to 6 Months (Month 6).

  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.

    Measured: Change from Baseline (Month 0) to 6 Months (Month 6).

  7. 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.

    Measured: Change from Baseline (Month 0) to 6 Months (Month 6).

  8. 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.

    Measured: Change from Baseline (Month 0) to 6 Months (Month 6).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2025
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06956872
Sponsor's protocol ID
NMRR-19-3569-50972A
Status last verified
May 2025
First submitted
23 Apr 2025
Last updated
4 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38553931

  • 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.

    PubMed 32795256

  • 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.

    PubMed 25959301

  • 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.

    PubMed 32478665

  • 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.

    PubMed 33066603

Questions about this trial

What is this clinical trial studying?

A study testing Counseling, Renal Diet App and Printed Nutrition Pamphlet in people with Chronic Kidney Disease Stage 3 and Chronic Kidney Disease, run by Universiti Putra Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zulfitri 'Azuan bin Mat Daud, Dietitian Lecturer [Dr] (+60-397692431, zulfitri@upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Dietary Adherence Score (time frame: Change from Baseline (Month 0) to 6 Months (Month 6).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06956872, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.

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