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Validation and Evaluation of a Newly Developed Mobile Diet App

Primary Purpose

Chronic Kidney Diseases, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Counseling
Renal Diet App
Printed Nutrition Pamphlet
Sponsored by
Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Kidney Diseases focused on measuring MyNutriKidney

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital SerdangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Counseling + Renal Diet App

Counseling + Printed Nutrition Pamphlet

Arm 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

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

Outcomes

Primary Outcome Measures

Glomerular Filtration Rate (eGFR)
Estimated glomerular filtration rate (eGFR) will be recorded in of mL/min/1.73m2.
Serum Kidney Function Test
Routine collected biochemical results from the patients' medical records: - urea, sodium, chloride, potassium and creatinine will be measured in mmol/L
Serum Hemoglobin A1C Test
Routine collected biochemical results from the patients' medical records for HbA1C (%)
Serum Blood Sugar Profile
Routine collected biochemical results from the patients' medical records and blood sugar (mmol/L) also will be recorded if patient had done self-monitoring blood glucose at home
Albuminuria
Routine collected urine analysis to measure urine albumin (mg) if there is presence of albumin or protein
Dietary History
Three-day diet records (3DDR) : 2 days weekdays + 1 weekend / dialysis and non-dialysis day. Measured unit is in kilocalories (kcal)/day
Dietary Adherence
End Stage Renal Disease Adherence Questionnaire (ESRD-AQ): - validated questionnaires which consists of 4 subscales pertaining dialysis, medication, dietary and fluid adherences. Patients will need to rate their fluid and dietary adherence on a numerical rating scale which composed of 0% (None of the time) to 100% (All of the time).

Secondary Outcome Measures

Feasibility of the app: interview
The feasibility of the app will be measured by the app usage. Study participants will be interviewed for app usage in term of frequency (e.g. in average how many days of usage in a week) and extent of its usage (e.g. how much time has spent on the app in a day). The intervention (mobile diet app) is consider feasible if the subject used the app more than 50% of study duration which is 42 days (6 weeks).
Acceptability: User Acceptance test (UAT)
Acceptability of the app will be measured using User Acceptance test (UAT). It consisted of 11 items and each item was rated on a 5-point Likert scale (1 = Strongly disagree, 3 = neutral, and 5 = Strongly agree).
Users Satisfaction: Likert scale
The evaluation questionnaire included 7 items evaluated using a five-point Likert scale (1 = Strongly disagree, 3 = neutral, and 5 = Strongly agree) on the composition of the app, on the design and layout of the app, and overall satisfaction.
Health Behaviour
A set of self-developed items will be used to assess the patient's perceptions of dietary adherence based on HBM constructs. Content validity have been done by 3 experts with the reported S-CVI/UA of 0.93. This part consisted of 28 items derived from available literatures, assessing different constructs of HBM
Nutrition Literacy
A dialysis-specific nutrition-related health literacy has been developed based on health literacy theory model (Sørensen et al., 2012) by the researchers and validated among HD patients with the content validity measured by S-CVI/AVE of 0.96 and construct validity measured by average variance extract (AVE) of 0.589 as well as composite reliability of 0.877 (unpublished data).
Nutritional Status
Anthropometry data will be collected by researchers at 2 time points, baseline (V0) and study end-point (V2). Malnutrition inflammation score (MIS) will be used to assess patient's nutritional status (Kalantar-Zadeh, Kopple, Block & Humphreys, 2001).
Dietary Knowledge
The kidney disease-related dietary knowledge questionnaire was modified from (Durose et al., 2004) based on the Malaysian MNT Guidelines for CKD, (MDA, 2005) which was adopted from the K-DOQI guidelines (NKF 2000; NKF 2003).

Full Information

First Posted
March 19, 2020
Last Updated
January 26, 2023
Sponsor
Universiti Putra Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04336033
Brief Title
Validation and Evaluation of a Newly Developed Mobile Diet App
Official Title
Validation and Evaluation of a Newly Developed Mobile Diet App for Enhancing Dietary Adherence for Patients With Chronic Kidney Disease (CKD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Anticipated)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Putra Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: To validate the newly developed mobile diet app for patient with chronic kidney disease. To determine the feasibility and acceptability of this newly developed mobile diet app among patients with chronic kidney disease. To evaluate the preliminary efficacy of the newly developed mobile diet app in enhancing dietary adherence in patients with chronic kidney disease

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Chronic Kidney Disease Requiring Chronic Dialysis
Keywords
MyNutriKidney

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Counseling + Renal Diet App
Arm Type
Experimental
Arm 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
Arm Title
Counseling + Printed Nutrition Pamphlet
Arm Type
Placebo Comparator
Arm Description
Individualized dietetic counseling aided with printed nutrition pamphlet prepared by Ministry of Health, Malaysia
Intervention Type
Other
Intervention Name(s)
Counseling
Intervention Description
Subjects in the both arms will receive individualized dietetic counseling as the standard dietetic care in Malaysia
Intervention Type
Other
Intervention Name(s)
Renal Diet App
Other Intervention Name(s)
MyNutriKidney
Intervention Description
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
Intervention Name(s)
Printed Nutrition Pamphlet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glomerular Filtration Rate (eGFR)
Description
Estimated glomerular filtration rate (eGFR) will be recorded in of mL/min/1.73m2.
Time Frame
3 months
Title
Serum Kidney Function Test
Description
Routine collected biochemical results from the patients' medical records: - urea, sodium, chloride, potassium and creatinine will be measured in mmol/L
Time Frame
3 months
Title
Serum Hemoglobin A1C Test
Description
Routine collected biochemical results from the patients' medical records for HbA1C (%)
Time Frame
3 months
Title
Serum Blood Sugar Profile
Description
Routine collected biochemical results from the patients' medical records and blood sugar (mmol/L) also will be recorded if patient had done self-monitoring blood glucose at home
Time Frame
2 weeks
Title
Albuminuria
Description
Routine collected urine analysis to measure urine albumin (mg) if there is presence of albumin or protein
Time Frame
12 weeks
Title
Dietary History
Description
Three-day diet records (3DDR) : 2 days weekdays + 1 weekend / dialysis and non-dialysis day. Measured unit is in kilocalories (kcal)/day
Time Frame
6 weeks
Title
Dietary Adherence
Description
End Stage Renal Disease Adherence Questionnaire (ESRD-AQ): - validated questionnaires which consists of 4 subscales pertaining dialysis, medication, dietary and fluid adherences. Patients will need to rate their fluid and dietary adherence on a numerical rating scale which composed of 0% (None of the time) to 100% (All of the time).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Feasibility of the app: interview
Description
The feasibility of the app will be measured by the app usage. Study participants will be interviewed for app usage in term of frequency (e.g. in average how many days of usage in a week) and extent of its usage (e.g. how much time has spent on the app in a day). The intervention (mobile diet app) is consider feasible if the subject used the app more than 50% of study duration which is 42 days (6 weeks).
Time Frame
12 weeks
Title
Acceptability: User Acceptance test (UAT)
Description
Acceptability of the app will be measured using User Acceptance test (UAT). It consisted of 11 items and each item was rated on a 5-point Likert scale (1 = Strongly disagree, 3 = neutral, and 5 = Strongly agree).
Time Frame
12 weeks
Title
Users Satisfaction: Likert scale
Description
The evaluation questionnaire included 7 items evaluated using a five-point Likert scale (1 = Strongly disagree, 3 = neutral, and 5 = Strongly agree) on the composition of the app, on the design and layout of the app, and overall satisfaction.
Time Frame
12 weeks
Title
Health Behaviour
Description
A set of self-developed items will be used to assess the patient's perceptions of dietary adherence based on HBM constructs. Content validity have been done by 3 experts with the reported S-CVI/UA of 0.93. This part consisted of 28 items derived from available literatures, assessing different constructs of HBM
Time Frame
12 weeks
Title
Nutrition Literacy
Description
A dialysis-specific nutrition-related health literacy has been developed based on health literacy theory model (Sørensen et al., 2012) by the researchers and validated among HD patients with the content validity measured by S-CVI/AVE of 0.96 and construct validity measured by average variance extract (AVE) of 0.589 as well as composite reliability of 0.877 (unpublished data).
Time Frame
12 weeks
Title
Nutritional Status
Description
Anthropometry data will be collected by researchers at 2 time points, baseline (V0) and study end-point (V2). Malnutrition inflammation score (MIS) will be used to assess patient's nutritional status (Kalantar-Zadeh, Kopple, Block & Humphreys, 2001).
Time Frame
12 weeks
Title
Dietary Knowledge
Description
The kidney disease-related dietary knowledge questionnaire was modified from (Durose et al., 2004) based on the Malaysian MNT Guidelines for CKD, (MDA, 2005) which was adopted from the K-DOQI guidelines (NKF 2000; NKF 2003).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically diagnosed CKD / eGFR < 60 ml/min/1.73m2 for ≥ 3 months (only applicable to pre-dialysis patients. Undergone maintenance dialysis for at least 3 months (only applicable to dialysis patients) Possessing smartphone and is willing to use health app Alert and oriented At least 18 years of age Exclusion Criteria: Inability to use the smartphone app (e.g. due to vision problems) Hard to comply with home monitoring (e.g. suffering from anxiety or depression) Refuse to comply with dietary prescription Patients who participate in other study at the same time Patients who have participated in another research study involving an investigational product in the past 12 weeks preceding enrollment. Planning for kidney transplant over the study duration. Female patients who are pregnant, lactating or planning a pregnancy during the course of the trial. Participants who are receiving nutritional support (i.e. enteral and intra-venous route). Participants who are currently receiving active treatment for cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nor Fadhlina binti Zakaria, Nephrologist
Phone
+603 8947 2561
Email
fadhsara@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zulfitri 'Azuan bin Mat Daud, Lecturer[Dr]
Organizational Affiliation
Universiti Putra Malaysia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barakatun Nisak binti Mohd Yusof, Lecturer[Dr]
Organizational Affiliation
Universiti Putra Malaysia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lim Jun Hao, Dietitian
Organizational Affiliation
Universiti Putra Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Serdang
City
Serdang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nor Fadhlina binti Zakaria, Nephrologist
Phone
+603 8947 2561
Email
fadhsara@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Ahmad, G., Leong, G. B., Ngo, L. Y., Meng, O. L., & Guat, L. D. (2016). 24th Report of the Malaysian Dialysis and Transplant Registry 2016. National Renal Registry Malaysia
Results Reference
result
PubMed Identifier
25959301
Citation
Campbell J, Porter J. Dietary mobile apps and their effect on nutritional indicators in chronic renal disease: A systematic review. Nephrology (Carlton). 2015 Oct;20(10):744-751. doi: 10.1111/nep.12500.
Results Reference
result
PubMed Identifier
22870215
Citation
Chan YM, Zalilah MS, Hii SZ. Determinants of compliance behaviours among patients undergoing hemodialysis in Malaysia. PLoS One. 2012;7(8):e41362. doi: 10.1371/journal.pone.0041362. Epub 2012 Aug 3.
Results Reference
result

Learn more about this trial

Validation and Evaluation of a Newly Developed Mobile Diet App

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