Mobile App Supporting Diet Self-Management in Chronic Kidney Disease

Trial details

Who runs it

Universiti Putra Malaysia

Trial code

NCT06956872

Record updated

4 May 2025

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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: Concurrent participation in another interventional research study; Participation in another research study involving an investigational product in the 12 weeks preceding potential enrollment; Currently receiving primary nutritional support via enteral tube feeding or parenteral (intra-venous) nutrition; Currently receiving active treatment for cancer (e.g., chemotherapy, radiotherapy); 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; 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; Known unwillingness or inability to comply with core study procedures, including dietary assessment components; Female participants who are pregnant, currently lactating, or planning a pregnancy during the course of the trial.

Participants must meet all of the following inclusion criteria and none of the exclusion criteria to be eligible for enrolment into the study.

ClinicalTrials.gov NCT06956872