Validation and Evaluation of a Newly Developed Mobile Diet App
- Conditions
- Chronic Kidney Disease stage4Chronic Kidney Disease Stage 5Chronic Kidney Disease Requiring Chronic DialysisChronic Kidney DiseasesChronic Kidney Disease stage3
- Interventions
- Other: CounselingOther: Renal Diet AppOther: Printed Nutrition Pamphlet
- Registration Number
- NCT04336033
- Lead Sponsor
- Universiti Putra Malaysia
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Counseling + Renal Diet App 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 Counseling + Printed Nutrition Pamphlet Counseling Individualized dietetic counseling aided with printed nutrition pamphlet prepared by Ministry of Health, Malaysia Counseling + Renal Diet App Counseling 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 Printed Nutrition Pamphlet Individualized dietetic counseling aided with printed nutrition pamphlet prepared by Ministry of Health, Malaysia
- Primary Outcome Measures
Name Time Method Serum Kidney Function Test 3 months Routine collected biochemical results from the patients' medical records:
- urea, sodium, chloride, potassium and creatinine will be measured in mmol/LSerum Blood Sugar Profile 2 weeks 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
Glomerular Filtration Rate (eGFR) 3 months Estimated glomerular filtration rate (eGFR) will be recorded in of mL/min/1.73m2.
Serum Hemoglobin A1C Test 3 months Routine collected biochemical results from the patients' medical records for HbA1C (%)
Albuminuria 12 weeks Routine collected urine analysis to measure urine albumin (mg) if there is presence of albumin or protein
Dietary History 6 weeks Three-day diet records (3DDR) : 2 days weekdays + 1 weekend / dialysis and non-dialysis day. Measured unit is in kilocalories (kcal)/day
Dietary Adherence 6 weeks 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
Name Time Method Acceptability: User Acceptance test (UAT) 12 weeks 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).
Nutrition Literacy 12 weeks 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).
Dietary Knowledge 12 weeks 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).
Feasibility of the app: interview 12 weeks 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).
Users Satisfaction: Likert scale 12 weeks 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 12 weeks 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
Nutritional Status 12 weeks 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).
Trial Locations
- Locations (1)
Hospital Serdang
🇲🇾Serdang, Selangor, Malaysia