Validation and Evaluation of a Newly Developed Mobile Diet App
1 other identifier
interventional
90
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2020
CompletedFirst Posted
Study publicly available on registry
April 7, 2020
CompletedStudy Start
First participant enrolled
February 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedJanuary 27, 2023
January 1, 2023
1 month
March 19, 2020
January 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Glomerular Filtration Rate (eGFR)
Estimated glomerular filtration rate (eGFR) will be recorded in of mL/min/1.73m2.
3 months
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
3 months
Serum Hemoglobin A1C Test
Routine collected biochemical results from the patients' medical records for HbA1C (%)
3 months
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
2 weeks
Albuminuria
Routine collected urine analysis to measure urine albumin (mg) if there is presence of albumin or protein
12 weeks
Dietary History
Three-day diet records (3DDR) : 2 days weekdays + 1 weekend / dialysis and non-dialysis day. Measured unit is in kilocalories (kcal)/day
6 weeks
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).
6 weeks
Secondary Outcomes (7)
Feasibility of the app: interview
12 weeks
Acceptability: User Acceptance test (UAT)
12 weeks
Users Satisfaction: Likert scale
12 weeks
Health Behaviour
12 weeks
Nutrition Literacy
12 weeks
- +2 more secondary outcomes
Study Arms (2)
Counseling + Renal Diet App
EXPERIMENTALSubjects 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
Counseling + Printed Nutrition Pamphlet
PLACEBO COMPARATORIndividualized dietetic counseling aided with printed nutrition pamphlet prepared by Ministry of Health, Malaysia
Interventions
Subjects in the both arms will receive individualized dietetic counseling as the standard dietetic care in Malaysia
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Serdang
Serdang, Selangor, 43000, Malaysia
Related Publications (3)
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
RESULTCampbell 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.
PMID: 25959301RESULTChan 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.
PMID: 22870215RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zulfitri 'Azuan bin Mat Daud, Lecturer[Dr]
Universiti Putra Malaysia
- PRINCIPAL INVESTIGATOR
Barakatun Nisak binti Mohd Yusof, Lecturer[Dr]
Universiti Putra Malaysia
- PRINCIPAL INVESTIGATOR
Lim Jun Hao, Dietitian
Universiti Putra Malaysia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator [Dietitian]
Study Record Dates
First Submitted
March 19, 2020
First Posted
April 7, 2020
Study Start
February 15, 2023
Primary Completion
March 30, 2023
Study Completion
April 30, 2023
Last Updated
January 27, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share