NCT06956872

Clinical Effectiveness of MyNutriKidney®

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Universiti Putra Malaysia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2025-05-04
• Last updated: 2025-05-04

Locations

1 site across 1 country: Malaysia