NCT04336033

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Universiti Putra Malaysia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-15
• Primary completion: 2023-03-30
• Completion: 2023-04-30
• First posted: 2020-04-07
• Last updated: 2023-01-27

Locations

1 site across 1 country: Malaysia