Chronic Kidney DiseasesNCT04336033
Validation and Evaluation of a Newly Developed Mobile Diet App
A study testing Counseling, Renal Diet App and Printed Nutrition Pamphlet in people with Chronic Kidney Diseases and Chronic Kidney Disease stage3, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
- What is being tested?
- Counseling, Renal Diet App and Printed Nutrition Pamphlet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Feb 2023to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Serdang
Serdang, Selangor, 43000
Nor Fadhlina binti Zakaria, Nephrologist, +603 8947 2561, fadhsara@yahoo.com
About this study
Official title: Validation and Evaluation of a Newly Developed Mobile Diet App for Enhancing Dietary Adherence for Patients With Chronic Kidney Disease (CKD)
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).
Read the 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
- Conditions
- Chronic Kidney Diseases, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Chronic Kidney Disease Requiring Chronic Dialysis
- Being tested
- Counseling, Renal Diet App, Printed Nutrition Pamphlet
- Keywords
- MyNutriKidney
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingOther
Subjects in the both arms will receive individualized dietetic counseling as the standard dietetic care in Malaysia
Renal Diet AppOther
Also called MyNutriKidney
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.
Printed Nutrition PamphletOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Counseling; Other: Renal Diet App |
| Counseling + Printed Nutrition Pamphlet | Placebo comparator | Individualized dietetic counseling aided with printed nutrition pamphlet prepared by Ministry of Health, Malaysia Receives: Other: Counseling; Other: Printed Nutrition Pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular Filtration Rate (eGFR)
Estimated glomerular filtration rate (eGFR) will be recorded in of mL/min/1.73m2.
Measured: 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
Measured: 3 months
Serum Hemoglobin A1C Test
Routine collected biochemical results from the patients' medical records for HbA1C (%)
Measured: 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
Measured: 2 weeks
Albuminuria
Routine collected urine analysis to measure urine albumin (mg) if there is presence of albumin or protein
Measured: 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
Measured: 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).
Measured: 6 weeks
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start15 Feb 2023 (estimated)
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jazlina binti Syahrul, Universiti Putra Malaysia
- Investigators
- Zulfitri 'Azuan bin Mat Daud, Lecturer[Dr], Principal investigator, Universiti Putra MalaysiaBarakatun Nisak binti Mohd Yusof, Lecturer[Dr], Principal investigator, Universiti Putra MalaysiaLim Jun Hao, Dietitian, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336033
- Sponsor's protocol ID
- NMRR-19-3569-50972
- Status last verified
- Jan 2023
- First submitted
- 19 Mar 2020
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
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.
PubMed 25959301Chan 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.
PubMed 22870215
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Evaluation of a Newly Developed Mobile Diet App for Enhancing Dietary Adherence for Patients With Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT04336033
- Acronym / sponsor ID
- NMRR-19-3569-50972
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Counseling + Renal Diet App | Experimental | Other: Counseling, Other: Renal Diet AppSubjects 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 | Other: Counseling, Other: Printed Nutrition PamphletIndividualized dietetic counseling aided with printed nutrition pamphlet prepared by Ministry of Health, Malaysia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingSubjects in the both arms will receive individualized dietetic counseling as the standard dietetic care in Malaysia | Other | Counseling + Printed Nutrition Pamphlet, Counseling + Renal Diet App |
| Renal Diet AppAlso: MyNutriKidneyIndividualized 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. | Other | Counseling + Renal Diet App |
| Printed Nutrition PamphletAfter 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. | Other | Counseling + Printed Nutrition Pamphlet |
Primary outcome
Glomerular Filtration Rate (eGFR)
Time frame: 3 months
Estimated glomerular filtration rate (eGFR) will be recorded in of mL/min/1.73m2.
Serum Kidney Function Test
Time frame: 3 months
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
Time frame: 3 months
Routine collected biochemical results from the patients' medical records for HbA1C (%)
Serum Blood Sugar Profile
Time frame: 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
Albuminuria
Time frame: 12 weeks
Routine collected urine analysis to measure urine albumin (mg) if there is presence of albumin or protein
Dietary History
Time frame: 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
Time frame: 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).
7 secondary outcomes
Feasibility of the app: interview
Time frame: 12 weeks
Acceptability: User Acceptance test (UAT)
Time frame: 12 weeks
Users Satisfaction: Likert scale
Time frame: 12 weeks
Health Behaviour
Time frame: 12 weeks
Nutrition Literacy
Time frame: 12 weeks
Nutritional Status
Time frame: 12 weeks
Dietary Knowledge
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Results publicationAhmad, 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 publication: PubMed 25959301Campbell 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 publication: PubMed 22870215Chan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zulfitri 'Azuan bin Mat Daud, Lecturer[Dr] principal investigator
Universiti Putra Malaysia
Barakatun Nisak binti Mohd Yusof, Lecturer[Dr] principal investigator
Universiti Putra Malaysia
Lim Jun Hao, Dietitian principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling, Renal Diet App and Printed Nutrition Pamphlet in people with Chronic Kidney Diseases and Chronic Kidney Disease stage3, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nor Fadhlina binti Zakaria, Nephrologist (+603 8947 2561, fadhsara@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular Filtration Rate (eGFR) (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04336033, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.