Clinical Effectiveness of MyNutriKidney®

NCT ID: NCT06956872

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-02-01

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)

Conditions

Chronic Kidney Disease Stage 3; Chronic Kidney Disease; Chronic Kidney Disease Stage 5; Chronic Kidney Disease Stage 4

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Counseling

Intervention Type: OTHER

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

Renal Diet App

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Counseling

Intervention Type: OTHER

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

Printed Nutrition Pamphlet

Intervention Type: 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.

Interventions

Counseling

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

MyNutriKidney

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Society of Nephrology

OTHER

Sponsor Role: collaborator

Universiti Putra Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Kent Leong Sim Kian

Principle Investigator [Dietitian]

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nor Fadhlina binti Zakaria, Nephrologist

Role: PRINCIPAL_INVESTIGATOR

Universiti Putra Malaysia

Barakatun Nisak binti Mohd Yusof, Dietitian Professor [Dr]

Role: PRINCIPAL_INVESTIGATOR

Universiti Putra Malaysia

Locations

Sultan Idris Shah Hospital, Serdang

Kajang, Selangor, Malaysia

Countries

Malaysia

Central Contacts

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

Role: CONTACT

zulfitri@upm.edu.my

+60-397692431

Leong Sim Kian, Dietitian

Role: CONTACT

+60-172946309

Facility Contacts

Nor Fadhlina binti Zakaria, Nephrologist

Role: primary

fadhsara@yahoo.com

+60-389472561

References

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.

Reference Type: BACKGROUND

PMID: 32795256 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25959301 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32478665 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33066603 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38553931 (View on PubMed)

Other Identifiers

NMRR-19-3569-50972A

Identifier Type: -

Identifier Source: org_study_id