Validation and Evaluation of a Newly Developed Mobile Diet App

University of Putra Malaysia (UPM)

Status: Enrolling

Conditions: Chronic Kidney Diseases; Chronic Kidney Disease stage3; Chronic Kidney Disease stage4; Chronic Kidney Disease Requiring Chronic Dialysis; Chronic Kidney Disease Stage 5

Treatments: Other: Renal Diet App; Other: Counseling; Other: Printed Nutrition Pamphlet

Study type: Interventional

Funder types: Other

Identifiers

NCT04336033

NMRR-19-3569-50972

Details and patient eligibility

About

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).

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups, including a placebo group

Counseling + Renal Diet App

Experimental group

Description:

Subjects in the intervention group will receive an individualized dietetic counseling from the researcher aided with the newly developed renal diet app for educative purpose and aiding tool to enhance the dietary adherence among CKD patients

Treatment:

Other: Renal Diet App

Other: Counseling

Counseling + Printed Nutrition Pamphlet

Placebo Comparator group

Description:

Individualized dietetic counseling aided with printed nutrition pamphlet prepared by Ministry of Health, Malaysia

Treatment:

Other: Counseling

Other: Printed Nutrition Pamphlet