Clinical trial NCT04336033: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Diseases
Chronic Kidney Disease stage3
Chronic Kidney Disease stage4
Chronic Kidney Disease Stage 5
Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: MyNutriKidney
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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:

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

Eligibility criteria: 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

Primary outcomes:
measure: Glomerular Filtration Rate (eGFR)
timeFrame: 3 months
measure: Serum Kidney Function Test
timeFrame: 3 months
measure: Serum Hemoglobin A1C Test
timeFrame: 3 months
measure: Serum Blood Sugar Profile
timeFrame: 2 weeks
measure: Albuminuria
timeFrame: 12 weeks
measure: Dietary History
timeFrame: 6 weeks
measure: Dietary Adherence
timeFrame: 6 weeks
Secondary outcomes:
measure: Feasibility of the app: interview
timeFrame: 12 weeks
measure: Acceptability: User Acceptance test (UAT)
timeFrame: 12 weeks
measure: Users Satisfaction: Likert scale
timeFrame: 12 weeks
measure: Health Behaviour
timeFrame: 12 weeks
measure: Nutrition Literacy
timeFrame: 12 weeks
measure: Nutritional Status
timeFrame: 12 weeks
measure: Dietary Knowledge
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Hospital Serdang
state: Selangor
Study officials:
affiliation: Universiti Putra Malaysia
name: Zulfitri 'Azuan bin Mat Daud, Lecturer[Dr]
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Putra Malaysia
name: Barakatun Nisak binti Mohd Yusof, Lecturer[Dr]
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Putra Malaysia
name: Lim Jun Hao, Dietitian
role: PRINCIPAL_INVESTIGATOR
References:
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
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.
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.