Clinical Effectiveness of MyNutriKidney®

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

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 could correctly record the foods and drinks with correct portion size eaten in the past 24 hours and successfully save the data.

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.

Sponsors & Collaborators

• International Society of Nephrology

  collaborator OTHER

• Universiti Putra Malaysia

  lead OTHER

Principal Investigators

• Nor Fadhlina binti Zakaria, Nephrologist · Universiti Putra Malaysia

• Barakatun Nisak binti Mohd Yusof, Dietitian Professor [Dr] · Universiti Putra Malaysia

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2027-02-01

Completion

2027-02-01

Countries

• Malaysia

Study Locations