Clinical Effectiveness of MyNutriKidney®

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.

NCT Number	NCT06956872
Lead Sponsor	Universiti Putra Malaysia Collaborators: International Society of Nephrology
Conditions	Chronic Kidney Disease Stage 3, Chronic Kidney Disease, Chronic Kidney Disease Stage 5, Chronic Kidney Disease Stage 4
Enrollment	200 participants
Start Date	2025-07-01
Primary Completion	2027-02-01 (estimated)
Study Completion	2027-02-01 (estimated)
Updated on ClinicalTrials.gov	2025-05-04