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Validation and Evaluation of a Newly Developed Mobile Diet App | Clinical Trials | Clareo Health

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Validation and Evaluation of a Newly Developed Mobile Diet App

Validation and Evaluation of a Newly Developed Mobile Diet App for Enhancing Dietary Adherence for Patients With Chronic Kidney Disease (CKD)

NCT04336033•Universiti Putra Malaysia

View on ClinicalTrials.gov

Summary

A 12-week, prospective, multicenter, open-label pilot randomized controlled trial (RCT) will be carried out to determine the feasibility, acceptability and potential clinical efficacy of a newly developed mobile diet app among CKD populations at different stages in Malaysia. Participants will be randomly assigned into either (i) intervention group (mobile diet app) or (ii) control group (dietary counseling using conventional pamphlet).

Detailed Description

General Objective: To evaluate a newly developed mobile diet app in enhancing dietary adherence for patients with chronic kidney disease. Specific Objectives: 1. To validate the newly developed mobile diet app for patient with chronic kidney disease. 2. To determine the feasibility and acceptability of this newly developed mobile diet app among patients with chronic kidney disease. 3. To evaluate the preliminary efficacy of the newly developed mobile diet app in enhancing dietary adherence in patients with chronic kidney disease

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Clinically diagnosed CKD / eGFR \< 60 ml/min/1.73m2 for ≥ 3 months (only applicable to pre-dialysis patients.
•2. Undergone maintenance dialysis for at least 3 months (only applicable to dialysis patients)
•3. Possessing smartphone and is willing to use health app
•4. Alert and oriented
•5. At least 18 years of age

Exclusion Criteria

•1. Inability to use the smartphone app (e.g. due to vision problems)
•2. Hard to comply with home monitoring (e.g. suffering from anxiety or depression)
•3. Refuse to comply with dietary prescription
•4. Patients who participate in other study at the same time
•5. Patients who have participated in another research study involving an investigational product in the past 12 weeks preceding enrollment.
•6. Planning for kidney transplant over the study duration.
•7. Female patients who are pregnant, lactating or planning a pregnancy during the course of the trial.
•8. Participants who are receiving nutritional support (i.e. enteral and intra-venous route).
•9. Participants who are currently receiving active treatment for cancer

Locations (1)

Hospital Serdang

Serdang, Selangor, Malaysia

Key Dates

Start Date

February 15, 2023

Primary Completion Date

March 30, 2023

Completion Date

April 30, 2023

Last Updated

January 27, 2023

Enrollment

ESTIMATED participants

Conditions

Chronic Kidney DiseasesChronic Kidney Disease stage3Chronic Kidney Disease stage4Chronic Kidney Disease Stage 5Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

Counseling

OTHER

Renal Diet App

OTHER

Printed Nutrition Pamphlet

OTHER

Contacts

Nor Fadhlina binti Zakaria, Nephrologist

CONTACT

+603 8947 2561 fadhsara@yahoo.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Validation and Evaluation of a Newly Developed Mobile Diet App

Inclusion Criteria

Exclusion Criteria

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