NCT06956872Not yet recruiting
Clinical Effectiveness of MyNutriKidney®
Clinical Effectiveness of MyNutriKidney® for Dietary Self-management in Chronic Kidney Disease Patients: Protocol for a Pragmatic Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 4 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 23 Apr 2025
- Start date
- Jul 2025
- Primary completion date
- Feb 2027
- Lead sponsor
- Universiti Putra Malaysia
- Diseases
- Chronic kidney disease
- NCT number
- NCT06956872
What you commit to
- Study type: Interventional
- Planned participants: 200
- From Jul 2025 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Criteria the registry did not label
- Participants must meet all of the following inclusion criteria and none of the exclusion criteria to be eligible for enrolment into the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sultan Idris Shah Hospital, Serdang Coordinator of this site? Confirm its status | Kajang | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.