Chronic Kidney Disease (Stages 3b-5), CKD
Conditions
Keywords
artificial intelligence, nutrition app, renal nutrition
Brief 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. 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.
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.
Interventions
OTHERMobile application empowerment approach
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.
Sponsors
Singapore General Hospital
Sengkang General Hospital
Singapore Institute of Technology
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Health-Related Quality of Life | 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 | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight Change | 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. |
| Percentage Weight Change | 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 (%). |
| Body Mass Index (BMI) | 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 |
| Nutritional Status [Subjective Global Assessment (SGA)} | 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. |
| Ease of Adherence to Diet Plan When Eating at Home | 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. |
| Energy Intake Relative to Estimated Requirements | 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. |
| Protein Intake Relative to Estimated Requirements | 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. |
| Sodium Intake Relative to Estimated Requirements | 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. |
| Phosphorus Intake Relative to Estimated Requirements | 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. |
| Potassium Intake Relative to Estimated Requirements | 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. |
Countries
Singapore
Contacts
CONTACTGary Tung Lin Chiah, MSc, BSc, RD
PRINCIPAL_INVESTIGATORGary Tung Lin Chiah, MSc, BSc, RD
Singapore Institute of Technology
Outcome results
None listed