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)

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).

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

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