Validation and Evaluation of a Newly Developed Mobile Diet App

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).

Conditions

• Chronic Kidney Diseases
• Chronic Kidney Disease stage3
• Chronic Kidney Disease stage4
• Chronic Kidney Disease Stage 5
• Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

OTHER

Counseling

Subjects in the both arms will receive individualized dietetic counseling as the standard dietetic care in Malaysia

OTHER

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.

OTHER

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.

Sponsors & Collaborators

• Universiti Putra Malaysia

  lead OTHER

Principal Investigators

• Zulfitri 'Azuan bin Mat Daud, Lecturer[Dr] · Universiti Putra Malaysia

• Barakatun Nisak binti Mohd Yusof, Lecturer[Dr] · Universiti Putra Malaysia

• Lim Jun Hao, Dietitian · Universiti Putra Malaysia

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-15

Primary Completion

2023-03-30

Completion

2023-04-30

Countries

• Malaysia

Study Locations