CKDNCT07804316
Fostering Self-Empowerment in CKD Patients Through Food Choice Mapping
An observational study of CKD and Chronic Kidney Disease (Stages 3b-5), run by Singapore Institute of Technology at 1 site in Singapore.
Trial summary
This project aims to develop mapping of food choices available for chronic kidney disease (CKD) patients when dining out in Singapore. Following the mapping, a mobile application will be developed based on renal dining out food map mobile application (RENDOFOMAP) and trialed on patients with CKD. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- CKD, Chronic Kidney Disease (Stages 3b-5)
- What is being tested?
- Mobile application empowerment approach
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Apr 2026to 16 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from inpatient and outpatient setting in a tertiary hospital
Who may be able to join
- Are fluent in English. This is necessary to ensure clear communication and understanding of study procedures and materials.
- Adequate proficiency in using smartphone i.e. downloading app, taking photo, completing e-forms within the mobile applications. This is essential for participants to effectively use the mobile application being tested.
- Diagnosed with CKD Stage 3B-5. This targets the specific patient population that the study aims to benefit.
Who cannot join
- Only fluent in languages other than English. This could hinder effective communication and understanding of the study.
- Diagnosis of cognitive deficit or neurological disorder. These conditions could impair the ability to follow study procedures or provide reliable data.
- Uncontrolled diabetes (HbA1c>8.5%). This condition could introduce additional health risks and confound study results.
- Recent hypoglycemic episodes. This could pose a safety risk during the study.
- Newly initiated on dialysis or planning for dialysis within the next 6 months. These patients may have rapidly changing health conditions that could affect study outcomes.
- Decompensated liver cirrhosis. This condition could complicate the interpretation of study results.
- Pregnant and lactating. These conditions could introduce additional variables that affect study outcomes.
- Inability to provide consent. This ensures that all participants can legally and ethically participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Singapore Institute of Technology
Singapore, 828608
Tung Lin Gary Chiah, +6597533317, gary.chiah@singaporetech.edu.sg
About this study
Official title: Fostering Self-Empowerment in Kidney Disease Patients Through Food Choice Mapping: A Pilot Study
This project aims to develop mapping of food choices available for chronic kidney disease (CKD) patients when dining out in Singapore. Following the mapping, a mobile application will be developed based on renal dining out food map mobile application (RENDOFOMAP) and trialed on patients with CKD. The specific aims of the project include:
- Mapping out food choices suitable for patients with CKD when dining out in Singapore which will eventually be translated into a mobile application incorporating simple AI functionality.
- To evaluate the impact of using RENDOFOMAP on self-empowerment, quality of life, nutritional status, and serum biochemistry in patients with CKD.
- To evaluate the acceptability and user experience of RENDOFOMAP
Participants with CKD will use the newly developed mobile application to find out if there is improvement in self-empowerment, quality of life, nutritional status, and serum biochemistry.
Read the detailed description
Diet is integral in CKD management; however, it is not sustainable for patients in the long term if there is solely emphasis on food restrictions without providing knowledge on modifying food choices to allow enjoyment. Thus, a strategic nutritional education approach needs to be adopted to maximise cost-effectiveness.
Patients' self-empowerment is gaining recognition as a means to optimise hospital resource utilisation, reduce healthcare costs, and decrease patients' dependency on medical services. This is particularly relevant for patients with chronic kidney disease (CKD), who are required to adhere to a disease management regimen that often conflicts with their pre-diagnosis lives and priorities.
In recent years, mobile applications have emerged as a popular platform for delivering nutrition education programs. Research indicates that mobile applications designed to engage patients and promote self-management of CKD show promise in improving adherence to dietary restrictions related to sodium, potassium, phosphorus, protein, calories, and fluid intake. Some of these applications offer a range of features but will still need to be reviewed by dietitians during face-to-face consultations. This in-depth approach, while beneficial, may not fully optimise time efficiency for dietitians.
Thus, there is an impetus to create an improved mobile application for CKD nutritional management to allow patients to individualise food choices, on top of charting food intake in the form of food diary. Patients can be trained to use the application during dietetics session which can eventually help reduce time spent for each session thereby improving dietitians' workload.
The proposed application will also incorporate some preliminary Artificial Intelligence (AI) to offer personalised food choices for patients. This feature is expected to further enhance the user-friendliness and convenience of the application, thereby promoting its usage and empowerment among CKD patients.
- Conditions
- CKD, Chronic Kidney Disease (Stages 3b-5)
- Being tested
- Mobile application empowerment approach
- Keywords
- artificial intelligence, nutrition app, renal nutrition
- 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.
Mobile application empowerment approachOther
Participant will be provided access to the prototype mobile application known for this trial.
Participants will be required to utilise the mobile application for 12 days (two 6-consecutive days, twice within 3 months) during a 3-month period. During the agreed dates, participant will need to take photos of their food intake and upload them onto the mobile application for evaluation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Health-Related Quality of Life
Physical Health-Related Quality of Life At baseline and Week 12-16, physical health-related quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12). The Physical Component Summary (PCS) score ranges from 5 to 20, with lower scores indicating better health-related quality of life and higher scores indicating poorer health-related quality of life.
Measured: Baseline to the end of study at 12-16 weeks
Mental Health-Related Quality of Life
At baseline and Week 12-16, mental health-related quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12). The Mental Component Summary (MCS) score ranges from 12 to 45, with lower scores indicating better health-related quality of life and higher scores indicating poorer health-related quality of life.
Measured: Baseline to the end of study at 12-16 weeks
Modified Nutrition-related Empowerment Scale
At baseline and Week 12-16, nutrition-related empowerment will be assessed using a modified version of the Korean Health Empowerment Scale (K-HES). The scale consists of 8 items scored from 1 (Strongly Disagree) to 5 (Strongly Agree). Item scores are summed to generate a total score ranging from 8 to 40, with higher scores indicating greater nutrition-related empowerment and self-management capacity.
Measured: Baseline to the end of study at 12-16 weeks
Ease of Adherence to Diet Plan When Eating Out
Participants will rate the ease of adhering to their prescribed diet plan when eating out using a 5-point scale ranging from 1 (very difficult) to 5 (very easy). Higher scores indicate greater ease of dietary adherence.
Measured: Baseline to the end of study at 12-16 weeks
Food Diary Completion Rate
Participant engagement with the nEAT mobile application will be assessed by the proportion of scheduled food diary entries completed during the intervention period. Food diary completion rate (%) = (Number of completed food diary entries ÷ Total number of scheduled food diary entries) × 100. A food diary entry is considered completed when the participant records the required dietary information for the scheduled eating occasion within the nEAT mobile application
Measured: Baseline to the end of study at 12-16 weeks
Secondary outcomes (10)
Body Weight Change
Body weight will be measured at baseline and Week 12-16 using a calibrated weighing scale. Weight will be reported in kilograms (kg). Body weight change (kg) = Body weight at Week 12-16 - Body weight at baseline. Negative values indicate a reduction in body weight (weight loss), positive values indicate an increase in body weight (weight gain), and a value of 0 indicates no change in body weight.
Measured: Baseline to the end of study at 12-16 weeks
Percentage Weight Change
Percentage weight change over the preceding 6 months will be calculated from self-reported and/or documented body weight records. Weight change will be reported as a percentage (%).
Measured: Baseline to the end of study at 12-16 weeks
Body Mass Index (BMI)
Body mass index (BMI) will be calculated as weight (kg) divided by height squared (m²), expressed as kg/m². BMI Asian categories are
Underweight: Less than 18.5 kg/m² Normal range: 18.5 to 22.9 kg/m² Overweight (At risk): 23.0 to 24.9 kg/m² Obese (Class I): 25.0 to 29.9 kg/m² Obese (Class II): ≥ 30.0 kg/m²
Measured: Baseline to the end of study at 12-16 weeks
Nutritional Status [Subjective Global Assessment (SGA)}
Nutritional status will be assessed using the Subjective Global Assessment (SGA), incorporating recent weight loss, dietary intake, gastrointestinal symptoms, functional status, muscle wasting, fat wasting, oedema, and overall nutritional status. Overall subjective scores range from 1 to 7, where 1-2 indicates severely malnourished, 3-5 moderately malnourished and 6-7 indicates being well nourished.
Measured: Baseline to the end of study at 12-16 weeks
Ease of Adherence to Diet Plan When Eating at Home
Participants will rate the ease of adhering to their prescribed diet plan when eating at home before and after using nEAT mobile application using a 5-point scale ranging from 1 (very difficult) to 5 (very easy). Higher scores indicate greater ease of dietary adherence.
Measured: Baseline to the end of study at 12-16 weeks
Energy Intake Relative to Estimated Requirements
Energy intake will be assessed using 24-hour dietary recalls completed at baseline and end of study at 12-16 weeks. Individual energy requirements will be estimated using the Harris-Benedict equation based on age (years), weight (kg), and height (cm), and used to establish personalized energy targets. Energy intake will be expressed as a percentage of the estimated energy requirement (%), calculated as actual energy intake divided by estimated energy requirement × 100. Values closer to 100% indicate greater adherence to prescribed energy targets.
Measured: Baseline to the end of study at 12-16 weeks
Protein Intake Relative to Estimated Requirements
Protein intake will be assessed using 24-hour dietary recalls completed at baseline and end of study at 12-16 weeks. Individual actual protein requirements will be estimated using the factor 0.8g/kg x weight (kg), and used to establish personalized energy targets. Protein intake will be expressed as a percentage of the estimated protein requirement (%), calculated as actual protein intake divided by estimated protein requirement × 100. Values closer to 100% indicate greater adherence to prescribed energy targets.
Measured: Baseline to the end of study at 12-16 weeks
Sodium Intake Relative to Estimated Requirements
Sodium intake will be assessed using 24-hour dietary recalls completed at baseline and end of study at 12-16 weeks. Individual sodium allowance will limited to 2000mg per person . Energy intake will be expressed as a percentage of the sodium allowance (%), calculated as actual sodium intake divided by estimated sodium allowance × 100. Values closer to 100% indicate greater adherence to prescribed sodium targets.
Measured: Baseline to the end of study at 12-16 weeks
Phosphorus Intake Relative to Estimated Requirements
Phosphorus intake will be assessed using 24-hour dietary recalls completed at baseline and end of study at 12-16 weeks. Individual phosphorus allowances will be personalised and estimated proportionally to protein intake. Phosphorus intake will be expressed as a percentage of the estimated phosphorus allowance (%), calculated as actual phosphorus intake divided by estimated phosphorus allowance × 100. Values closer to 100% indicate greater adherence to prescribed phosphorus targets.
Measured: Baseline to the end of study at 12-16 weeks
Potassium Intake Relative to Estimated Requirements
Potassium intake will be assessed using 24-hour dietary recalls completed at baseline and end of study at 12-16 weeks. Individual potassium allowance will calculated at 39mg/kg per person, however, will be personalised based on the chronic kidney stage and serum biochemistry potassium. Potassium intake will be expressed as a percentage of the individualised potassium allowance (%), calculated as actual sodium intake divided by estimated potassium allowance × 100. Values closer to 100% indicate greater adherence to prescribed potassium targets.
Measured: Baseline to the end of study at 12-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start15 Apr 2026
- Primary completion16 Jan 2027 (estimated)
- Study completion16 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital, Sengkang General Hospital
- Responsible party
- Principal investigator, Gary Tung Lin Chiah, Singapore Institute of Technology
- Investigators
- Gary Tung Lin Chiah, MSc, BSc, RD, Principal investigator, Singapore Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804316
- Sponsor's protocol ID
- RECAS-0658
- Other IDs
- IG (S) 1/2024 - 1021
- Status last verified
- Oct 2025
- First submitted
- 19 Jul 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fostering Self-Empowerment in Kidney Disease Patients Through Food Choice Mapping: A Pilot Study
- ClinicalTrials.gov ID
- NCT07804316
- Acronym / sponsor ID
- RECAS-0658
- Conditions
- CKD, Chronic Kidney Disease (Stages 3b-5)
- Keywords
- artificial intelligence, nutrition app, renal nutrition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Singapore Institute of TechnologyUniversity, hospital or other
- Collaborators
- Singapore General Hospital, Sengkang General Hospital
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 16 Jan 2027 (estimated)
- Study completion
- 16 Aug 2027 (estimated)
- First posted
- 4 Sep 2026 (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.
This project aims to develop mapping of food choices available for chronic kidney disease (CKD) patients when dining out in Singapore. Following the mapping, a mobile application will be developed based on renal dining out food map mobile application (RENDOFOMAP) and trialed on patients with CKD. The specific aims of the project include:
- Mapping out food choices suitable for patients with CKD when dining out in Singapore which will eventually be translated into a mobile application incorporating simple AI functionality.
- To evaluate the impact of using RENDOFOMAP on self-empowerment, quality of life, nutritional status, and serum biochemistry in patients with CKD.
- To evaluate the acceptability and user experience of RENDOFOMAP
Participants with CKD will use the newly developed mobile application to find out if there is improvement in self-empowerment, quality of life, nutritional status, and serum biochemistry.
Detailed description
Diet is integral in CKD management; however, it is not sustainable for patients in the long term if there is solely emphasis on food restrictions without providing knowledge on modifying food choices to allow enjoyment. Thus, a strategic nutritional education approach needs to be adopted to maximise cost-effectiveness.
Patients' self-empowerment is gaining recognition as a means to optimise hospital resource utilisation, reduce healthcare costs, and decrease patients' dependency on medical services. This is particularly relevant for patients with chronic kidney disease (CKD), who are required to adhere to a disease management regimen that often conflicts with their pre-diagnosis lives and priorities.
In recent years, mobile applications have emerged as a popular platform for delivering nutrition education programs. Research indicates that mobile applications designed to engage patients and promote self-management of CKD show promise in improving adherence to dietary restrictions related to sodium, potassium, phosphorus, protein, calories, and fluid intake. Some of these applications offer a range of features but will still need to be reviewed by dietitians during face-to-face consultations. This in-depth approach, while beneficial, may not fully optimise time efficiency for dietitians.
Thus, there is an impetus to create an improved mobile application for CKD nutritional management to allow patients to individualise food choices, on top of charting food intake in the form of food diary. Patients can be trained to use the application during dietetics session which can eventually help reduce time spent for each session thereby improving dietitians' workload.
The proposed application will also incorporate some preliminary Artificial Intelligence (AI) to offer personalised food choices for patients. This feature is expected to further enhance the user-friendliness and convenience of the application, thereby promoting its usage and empowerment among CKD patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from inpatient and outpatient setting in a tertiary hospital
Key inclusion criteria (3 listed)
- Are fluent in English. This is necessary to ensure clear communication and understanding of study procedures and materials.
- Adequate proficiency in using smartphone i.e. downloading app, taking photo, completing e-forms within the mobile applications. This is essential for participants to effectively use the mobile application being tested.
- Diagnosed with CKD Stage 3B-5. This targets the specific patient population that the study aims to benefit.
Key exclusion criteria (8 listed)
- Only fluent in languages other than English. This could hinder effective communication and understanding of the study.
- Diagnosis of cognitive deficit or neurological disorder. These conditions could impair the ability to follow study procedures or provide reliable data.
- Uncontrolled diabetes (HbA1c>8.5%). This condition could introduce additional health risks and confound study results.
- Recent hypoglycemic episodes. This could pose a safety risk during the study.
- Newly initiated on dialysis or planning for dialysis within the next 6 months. These patients may have rapidly changing health conditions that could affect study outcomes.
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 |
|---|---|---|
| Mobile application empowerment approachParticipant will be provided access to the prototype mobile application known for this trial. Participants will be required to utilise the mobile application for 12 days (two 6-consecutive days, twice within 3 months) during a 3-month period. During the agreed dates, participant will need to take photos of their food intake and upload them onto the mobile application for evaluation. | Other | – |
Primary outcome
Physical Health-Related Quality of Life
Time frame: Baseline to the end of study at 12-16 weeks
Physical Health-Related Quality of Life At baseline and Week 12-16, physical health-related quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12). The Physical Component Summary (PCS) score ranges from 5 to 20, with lower scores indicating better health-related quality of life and higher scores indicating poorer health-related quality of life.
Mental Health-Related Quality of Life
Time frame: Baseline to the end of study at 12-16 weeks
At baseline and Week 12-16, mental health-related quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12). The Mental Component Summary (MCS) score ranges from 12 to 45, with lower scores indicating better health-related quality of life and higher scores indicating poorer health-related quality of life.
Modified Nutrition-related Empowerment Scale
Time frame: Baseline to the end of study at 12-16 weeks
At baseline and Week 12-16, nutrition-related empowerment will be assessed using a modified version of the Korean Health Empowerment Scale (K-HES). The scale consists of 8 items scored from 1 (Strongly Disagree) to 5 (Strongly Agree). Item scores are summed to generate a total score ranging from 8 to 40, with higher scores indicating greater nutrition-related empowerment and self-management capacity.
Ease of Adherence to Diet Plan When Eating Out
Time frame: Baseline to the end of study at 12-16 weeks
Participants will rate the ease of adhering to their prescribed diet plan when eating out using a 5-point scale ranging from 1 (very difficult) to 5 (very easy). Higher scores indicate greater ease of dietary adherence.
Food Diary Completion Rate
Time frame: Baseline to the end of study at 12-16 weeks
Participant engagement with the nEAT mobile application will be assessed by the proportion of scheduled food diary entries completed during the intervention period. Food diary completion rate (%) = (Number of completed food diary entries ÷ Total number of scheduled food diary entries) × 100. A food diary entry is considered completed when the participant records the required dietary information for the scheduled eating occasion within the nEAT mobile application
10 secondary outcomes
Body Weight Change
Time frame: Baseline to the end of study at 12-16 weeks
Percentage Weight Change
Time frame: Baseline to the end of study at 12-16 weeks
Body Mass Index (BMI)
Time frame: Baseline to the end of study at 12-16 weeks
Nutritional Status [Subjective Global Assessment (SGA)}
Time frame: Baseline to the end of study at 12-16 weeks
Ease of Adherence to Diet Plan When Eating at Home
Time frame: Baseline to the end of study at 12-16 weeks
Energy Intake Relative to Estimated Requirements
Time frame: Baseline to the end of study at 12-16 weeks
Protein Intake Relative to Estimated Requirements
Time frame: Baseline to the end of study at 12-16 weeks
Sodium Intake Relative to Estimated Requirements
Time frame: Baseline to the end of study at 12-16 weeks
Phosphorus Intake Relative to Estimated Requirements
Time frame: Baseline to the end of study at 12-16 weeks
Potassium Intake Relative to Estimated Requirements
Time frame: Baseline to the end of study at 12-16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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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.
Gary Tung Lin Chiah, MSc, BSc, RD principal investigator
Singapore Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD and Chronic Kidney Disease (Stages 3b-5), run by Singapore Institute of Technology at 1 site in Singapore.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. 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 Singapore. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gary Tung Lin Chiah, MSc, BSc, RD (+6565925769, gary.chiah@singaporetech.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Health-Related Quality of Life (time frame: Baseline to the end of study at 12-16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2026.