[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589627":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":37,"centralContacts":43,"locations":52,"responsibleParty":70,"collaborators":73,"id":76,"slug":26,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":26,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":26,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":108,"whyStopped":26,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Universiti Putra Malaysia","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Care + Renal Diet App","EXPERIMENTAL","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.",[13,14],"Other: Counseling","Other: Renal Diet App",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Care","PLACEBO_COMPARATOR","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.",[13,20],"Other: Printed Nutrition Pamphlet",[22,27,33],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"Counseling","Subjects in the both arms will receive individualized dietetic counseling as the standard dietetic care in Malaysia",[16,9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Renal Diet App","Individualized dietetic counseling aided with a newly developed renal diet app for educative purpose and aiding tool to enhance the dietary adherence among CKD patients. Training on the use of the app will be provided to the subjects prior to the commencement of the intervention. Subjects will be trained on the use of the home screen, icons, feedback screens, the process of entering dietary and fluid intake data and selecting portion sizes. Subjects are considered as competent users when they could correctly record the foods and drinks with correct portion size eaten in the past 24 hours and successfully save the data.",[9],[32],"MyNutriKidney",{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":26},"Printed Nutrition Pamphlet","After the counseling session, a standardized renal nutrition pamphlet prepared by dietitians from Universiti Putra Malaysia and Hospital Serdang will be given for patient's educative purpose. Since the mobile application is intended for patient's education and self-monitoring (food diary) purposes, and thus, to ensure the comparability between intervention and control groups, the patients in control group will be trained to record their diet intakes manually using the recommended approach 3-day diet records. Nutritional feedback or advices on the diet records will be given to the participants during follow up sessions.",[16],[38,41],{"name":39,"affiliation":5,"role":40},"Nor Fadhlina binti Zakaria, Nephrologist","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":5,"role":40},"Barakatun Nisak binti Mohd Yusof, Dietitian Professor [Dr]",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":26,"email":48},"Zulfitri 'Azuan bin Mat Daud, Dietitian Lecturer [Dr]","CONTACT","+60-397692431","zulfitri@upm.edu.my",{"name":50,"role":46,"phone":51,"phoneExt":26,"email":26},"Leong Sim Kian, Dietitian","+60-172946309",[53],{"facility":54,"status":26,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Sultan Idris Shah Hospital, Serdang","Kajang","Selangor","43000","Malaysia","MY",{"type":61,"coordinates":62},"Point",[63,64],101.78875,2.99424,{"lat":64,"lon":63},[67],{"name":39,"role":46,"phone":68,"phoneExt":26,"email":69},"+60-389472561","fadhsara@yahoo.com",{"type":40,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Kent Leong Sim Kian","Principle Investigator [Dietitian]",[74],{"name":75,"class":6},"International Society of Nephrology","100589627",false,"NCT06956872","Clinical Effectiveness of MyNutriKidney®","Clinical Effectiveness of MyNutriKidney® for Dietary Self-management in Chronic Kidney Disease Patients: Protocol for a Pragmatic Randomized Controlled Trial","Participants must meet all of the following inclusion criteria and none of the exclusion criteria to be eligible for enrolment into the study.\n\nInclusion Criteria:\n\n1. Clinically diagnosed Chronic Kidney Disease (CKD):\n\n   1.1. eGFR \\\u003C 60 ml\u002Fmin\u002F1.73m² for ≥ 3 months (applicable to pre-dialysis patients, Stages 3-5)\n2. Aged 18 years or older.\n3. Possesses a personal smartphone compatible with the MyNutriKidney® application and is willing to use the health app if randomized to the intervention group.\n4. Alert and oriented, and deemed capable of providing informed consent and participating in study procedures.\n5. Able to communicate and understand study procedures in English, Bahasa Melayu, or Mandarin.\n\nExclusion Criteria:\n\n1. Inability to effectively use the smartphone application due to significant impairments (e.g., severe visual or motor problems).\n2. Smartphone owned by the participant does not meet the minimum technical requirements for the MyNutriKidney® application installation and operation\n3. 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.\n4. Known unwillingness or inability to comply with core study procedures, including dietary assessment components.\n5. Concurrent participation in another interventional research study.\n6. Participation in another research study involving an investigational product in the 12 weeks preceding potential enrollment.\n7. Female participants who are pregnant, currently lactating, or planning a pregnancy during the course of the trial.\n8. Currently receiving primary nutritional support via enteral tube feeding or parenteral (intra-venous) nutrition.\n9. Currently receiving active treatment for cancer (e.g., chemotherapy, radiotherapy).","ALL","18 Years",{"count":85,"type":86},200,"ESTIMATED","INTERVENTIONAL",[89],"NA","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.",[92,93,94,95],"Chronic Kidney Disease Stage 3","Chronic Kidney Disease","Chronic Kidney Disease Stage 5","Chronic Kidney Disease Stage 4",[32,97,98,99,100,101,102,103,104,105,106,58,107],"chronic kidney disease","CKD","Dietary Adherence","Nutrition Literacy","Self-management","Mobile Health","Dietitian","mHealth","Telemedicine","Digital Health","Kidney Diseases","NOT_YET_RECRUITING","2025-05-01",{"date":111,"type":112},"2025-05-04","ACTUAL",{"date":114,"type":86},"2025-07-01",{"date":116,"type":86},"2027-02-01",{"name":5,"class":6},1]