Clinical Effectiveness of MyNutriKidney®

University of Putra Malaysia (UPM)

Status: Not yet enrolling

Conditions: Chronic Kidney Disease; Chronic Kidney Disease Stage 3; Chronic Kidney Disease Stage 4; Chronic Kidney Disease Stage 5

Treatments: Other: Counseling; Other: Printed Nutrition Pamphlet; Other: Renal Diet App

Study type: Interventional

Funder types: Other

Identifiers

NCT06956872

NMRR-19-3569-50972A

Details and patient eligibility

About

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.

Full 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)

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

1. 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)

2. Aged 18 years or older.

3. Possesses a personal smartphone compatible with the MyNutriKidney® application and is willing to use the health app if randomized to the intervention group.

4. Alert and oriented, and deemed capable of providing informed consent and participating in study procedures.

5. Able to communicate and understand study procedures in English, Bahasa Melayu, or Mandarin.

Exclusion Criteria:

1. Inability to effectively use the smartphone application due to significant impairments (e.g., severe visual or motor problems).
2. Smartphone owned by the participant does not meet the minimum technical requirements for the MyNutriKidney® application installation and operation
3. 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.
4. Known unwillingness or inability to comply with core study procedures, including dietary assessment components.
5. Concurrent participation in another interventional research study.
6. Participation in another research study involving an investigational product in the 12 weeks preceding potential enrollment.
7. Female participants who are pregnant, currently lactating, or planning a pregnancy during the course of the trial.
8. Currently receiving primary nutritional support via enteral tube feeding or parenteral (intra-venous) nutrition.
9. Currently receiving active treatment for cancer (e.g., chemotherapy, radiotherapy).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

Standard Care + Renal Diet App

Experimental group

Description:

Participants receive usual standard care for CKD stages 3-5, supplemented with the use of the MyNutriKidney® mobile application for a 6-month period. Following onboarding and training, participants utilize the app for daily manual meal logging, receive automated nutrient estimations and real-time feedback against personalized dietary recommendations (utilizing a Malaysian food database), access tailored educational modules, engage with gamification features (challenges, progress tracking), and receive periodic personalized feedback from study dietitians via in-app messaging or virtual consultations. Technical support is available.

Treatment:

Other: Renal Diet App

Other: Counseling

Standard Care

Placebo Comparator group

Description:

Participants receive usual standard care for CKD stages 3-5 as provided at the participating clinics for a 6-month period. This typically includes face-to-face dietary counseling sessions with a clinic dietitian scheduled based on clinical need (e.g., every 1-3 months), provision of standard printed educational materials and general CKD dietary guidelines, and routine clinical and laboratory monitoring by their usual healthcare providers. Participants in this group do not receive access to the MyNutriKidney® app during the study.

Treatment:

Other: Printed Nutrition Pamphlet

Other: Counseling