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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).
General Objective: To evaluate a newly developed mobile diet app in enhancing dietary adherence for patients with chronic kidney disease.
Specific Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Counseling + Renal Diet App | Experimental | 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 |
|
| Counseling + Printed Nutrition Pamphlet | Placebo Comparator | Individualized dietetic counseling aided with printed nutrition pamphlet prepared by Ministry of Health, Malaysia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling | Other | Subjects in the both arms will receive individualized dietetic counseling as the standard dietetic care in Malaysia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nor Fadhlina binti Zakaria, Nephrologist | Contact | +603 8947 2561 | fadhsara@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Zulfitri 'Azuan bin Mat Daud, Lecturer[Dr] | Universiti Putra Malaysia | Principal Investigator |
| Barakatun Nisak binti Mohd Yusof, Lecturer[Dr] | Universiti Putra Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Serdang | Recruiting | Serdang | Selangor | 43000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 | ||
| 25959301 | Result | 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. | |
| 22870215 |
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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.
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| Renal Diet App | 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. |
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| Printed Nutrition Pamphlet | 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. |
|
| 6 weeks |
| 12 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). | 12 weeks |
| 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. | 12 weeks |
| 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 | 12 weeks |
| 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). | 12 weeks |
| 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). | 12 weeks |
| 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). | 12 weeks |
| Lim Jun Hao, Dietitian | Universiti Putra Malaysia | Principal Investigator |
| Result |
| 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. |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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