Validation and Evaluation of a Newly Developed Mobile Diet App

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2023-04-30

Brief Summary

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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).

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A 12-week, open-label, multicenter, randomized controlled pilot study (RCT) will be implemented to evaluate the feasibility, acceptability as well as preliminary efficacy of the newly developed renal diet app in enhancing dietary adherence among CKD patients at different stages in Malaysia. Participants will be randomly assigned in the ratio of 1:1 into two arms.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Counseling + Renal Diet App

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

Group Type EXPERIMENTAL

Counseling

Intervention Type OTHER

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

Renal Diet App

Intervention Type OTHER

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.

Counseling + Printed Nutrition Pamphlet

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

Group Type PLACEBO_COMPARATOR

Counseling

Intervention Type OTHER

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

Printed Nutrition Pamphlet

Intervention Type OTHER

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.

Interventions

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Counseling

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

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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MyNutriKidney

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No