Clinical Effectiveness of MyNutriKidney®

Official title

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

Overview

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)

Interventions

• 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 co
• 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

Primary outcome measures

• Change in Dietary Adherence Score [Time frame: 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).]

Secondary outcome measures (8)

• Change in Dietary Knowledge Score [Time frame: 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)]
• Change in Serum Albumin Level [Time frame: 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).]
• Change in Serum Potassium Level [Time frame: 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).]
• Change in Serum Sodium Level [Time frame: 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).]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Malaysia · 1 center

• Sultan Idris Shah Hospital, Serdang — Kajang

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 33066603

Identifiers

NCT: NCT06956872 · NMRR-19-3569-50972A

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗