Clinical trial NCT06956872: Clinical Effectiveness of MyNutriKidney®
Official title: Clinical Effectiveness of MyNutriKidney® for Dietary Self-management in Chronic Kidney Disease Patients: Protocol for a Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease Stage 3
Chronic Kidney Disease
Chronic Kidney Disease Stage 5
Chronic Kidney Disease Stage 4
Keywords: MyNutriKidney
chronic kidney disease
CKD
Dietary Adherence
Nutrition Literacy
Self-management
Mobile Health
Dietitian
mHealth
Telemedicine
Digital Health
Malaysia
Kidney Diseases
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: International Society of Nephrology
First posted: 2025-05-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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)

Eligibility 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).

Primary outcomes:
measure: Change in Dietary Adherence Score
timeFrame: Change from Baseline (Month 0) to 6 Months (Month 6).
measure: Change in Nutrition Literacy Score
timeFrame: Change from Baseline (Month 0) to 6 Months (Month 6).
Secondary outcomes:
measure: Change in Dietary Knowledge Score
timeFrame: Change from Baseline (Month 0) to 6 Months (Month 6).
measure: Change in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Change from Baseline (Month 0) to 6 Months (Month 6)
measure: Change in Serum Albumin Level
timeFrame: Change from Baseline (Month 0) to 6 Months (Month 6).
measure: Change in Hemoglobin Level
timeFrame: Change from Baseline (Month 0) to 6 Months (Month 6).
measure: Change in Serum Potassium Level
timeFrame: Change from Baseline (Month 0) to 6 Months (Month 6).
measure: Change in Serum Phosphorus Level
timeFrame: Change from Baseline (Month 0) to 6 Months (Month 6).
measure: Change in Serum Sodium Level
timeFrame: Change from Baseline (Month 0) to 6 Months (Month 6).
measure: Change in Corrected Serum Calcium Level
timeFrame: Change from Baseline (Month 0) to 6 Months (Month 6).
Other outcomes:
measure: App Usability and Satisfaction Score
timeFrame: Assessed at 6 Months (Month 6).
measure: Average Weekly Meal Logging Frequency
timeFrame: Calculated as an average over the period from Baseline (Month 0) to 6 Months (Month 6).
measure: Average Weekly Time on Educational Modules
timeFrame: Calculated as an average over the period from Baseline (Month 0) to 6 Months (Month 6).
measure: Total Number of Gamification Challenges Completed
timeFrame: Calculated as a total over the period from Baseline (Month 0) to 6 Months (Month 6).
measure: Interaction Rate with Actionable Reminders
timeFrame: Calculated over the period from Baseline (Month 0) to 6 Months (Month 6)
Locations:
city: Kajang
country: Malaysia
facility: Sultan Idris Shah Hospital, Serdang
state: Selangor
Study officials:
affiliation: Universiti Putra Malaysia
name: Nor Fadhlina binti Zakaria, Nephrologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Putra Malaysia
name: Barakatun Nisak binti Mohd Yusof, Dietitian Professor [Dr]
role: PRINCIPAL_INVESTIGATOR
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