Fostering Self-Empowerment in CKD Patients Through Food Choice Mapping

September 2, 2026 updated by: Gary Tung Lin Chiah, Singapore Institute of Technology

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:

  1. 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.
  2. To evaluate the impact of using RENDOFOMAP on self-empowerment, quality of life, nutritional status, and serum biochemistry in patients with CKD.
  3. 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from inpatient and outpatient setting in a tertiary hospital

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to the end of study at 12-16 weeks
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.
Baseline to the end of study at 12-16 weeks
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.
Baseline to the end of study at 12-16 weeks
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.
Baseline to the end of study at 12-16 weeks
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
Baseline to the end of study at 12-16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Weight Change
Time Frame: Baseline to the end of study at 12-16 weeks
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.
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
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 (%).
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

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
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Baseline to the end of study at 12-16 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline to the end of study at 12-16 weeks
Estimated glomerular filtration rate (eGFR), a laboratory-based measure of kidney function, will be assessed at baseline and at the end of the study (12-16 weeks). eGFR will be reported in millilitres per minute per 1.73 m² (mL/min/1.73 m²). The outcome measure will be the change in eGFR from baseline to study completion. Lower eGFR values compared to baseline indicate poorer kidney function.
Baseline to the end of study at 12-16 weeks
Change in Serum Creatinine
Time Frame: Baseline to the end of study at 12-16 weeks
Renal function will be assessed by measuring serum creatinine concentration and reported in micromoles per litre (µmol/L) at baseline and end of study at 12-16 weeks. Higher values from baseline indicate poorer or declining kidney function. Reference value, male: 54 - 101; female: 37 - 75 µmol/L
Baseline to the end of study at 12-16 weeks
Serum Potassium Concentration
Time Frame: Baseline to the end of study at 12-16 weeks
Serum potassium concentration will be measured and reported in millimoles per litre (mmol/L). Reference value: 3.6 - 5.0 mmol/L. Higher value from baseline signifies worsening of hyperkalemia
Baseline to the end of study at 12-16 weeks
Change in Serum Albumin
Time Frame: Baseline to the end of study at 12-16 weeks
Nutritional status will be assessed using serum albumin concentration and reported in grams per litre (g/L) at baseline and end of study at 12-16 weeks. Higher values indicate better nutritional status compared to baseline. Reference value: 40 - 51 g/L
Baseline to the end of study at 12-16 weeks
CKD-Related Hospital Admissions Compared Against Compliance to 24-hour Diet Recall
Time Frame: End of study at 12-16 weeks
Hospital admissions related to chronic kidney disease or its complications occurring during the study period will be recorded and reported as the total number of admissions in comparison to the stratification of24-hour Diet Recall.
End of study at 12-16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Singapore Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Singapore General Hospital
Sengkang General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gary Tung Lin Chiah, MSc, BSc, RD, Singapore Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECAS-0658
  • IG (S) 1/2024 - 1021 (Other Identifier: Singapore Institute of Technology)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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