Clinical Effectiveness of MyNutriKidney®

NCT06956872 | Not Yet Recruiting

• 1 other identifier: NMRR-19-3569-50972A
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

MyNutriKidney; chronic kidney disease; CKD; Dietary Adherence; Nutrition Literacy; Self-management; Mobile Health; Dietitian; mHealth; Telemedicine; Digital Health; Malaysia; Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• 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).

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

• 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).

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

Secondary Outcomes (8)

• Change in Dietary Knowledge Score

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

• Change in Estimated Glomerular Filtration Rate (eGFR)

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

• Change in Serum Albumin Level

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

• Change in Hemoglobin Level

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

• Change in Serum Potassium Level

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

Other Outcomes (5)

• App Usability and Satisfaction Score

  Assessed at 6 Months (Month 6).

• Average Weekly Meal Logging Frequency

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

• Average Weekly Time on Educational Modules

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

Study Arms (2)

Standard Care + Renal Diet App

EXPERIMENTAL

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; Other: Renal Diet App

Standard Care

PLACEBO COMPARATOR

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; Other: Printed Nutrition Pamphlet

Interventions

Counseling OTHER

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

Standard Care; Standard Care + Renal Diet App

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.

Also known as: MyNutriKidney

Standard Care + Renal Diet App

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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Clinically diagnosed Chronic Kidney Disease (CKD):
• 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.
• 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).

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• International Society of Nephrology: collaborator

Study Sites (1)

Sultan Idris Shah Hospital, Serdang

Kajang, Selangor, 43000, Malaysia

Location

Related Publications (5)

• 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.

  PMID: 32795256 BACKGROUND

• 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.

  PMID: 25959301 BACKGROUND

• 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.

  PMID: 32478665 BACKGROUND

• 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.

  PMID: 33066603 BACKGROUND

• 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.

  PMID: 38553931 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases

Interventions

Counseling

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nor Fadhlina binti Zakaria, Nephrologist

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

• Barakatun Nisak binti Mohd Yusof, Dietitian Professor [Dr]

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+60-397692431; zulfitri@upm.edu.my

Leong Sim Kian, Dietitian

CONTACT

+60-172946309

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator [Dietitian]

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 4, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)