Fostering Self-Empowerment in CKD Patients Through Food Choice Mapping
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorSingapore Institute of Technology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Participants will be recruited from inpatient and outpatient setting in a tertiary hospital
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Mobile application empowerment approach
Other interventionParticipant 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to the end of study at 12-16 weeks2
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.
Time frame
Baseline to the end of study at 12-16 weeks3
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.
Time frame
Baseline to the end of study at 12-16 weeks4
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.
Time frame
Baseline to the end of study at 12-16 weeksSecondary outcomes
1
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.
Time frame
Baseline to the end of study at 12-16 weeks2
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 (%).
Time frame
Baseline to the end of study at 12-16 weeks3
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
Time frame
Baseline to the end of study at 12-16 weeks4
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.
Time frame
Baseline to the end of study at 12-16 weeksOther outcomes
1
Change in Estimated Glomerular Filtration Rate (eGFR)
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.
Time frame
Baseline to the end of study at 12-16 weeks2
Change in Serum Creatinine
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
Time frame
Baseline to the end of study at 12-16 weeks3
Serum Potassium Concentration
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
Time frame
Baseline to the end of study at 12-16 weeks4
Change in Serum Albumin
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
Time frame
Baseline to the end of study at 12-16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Singapore Institute of Technology
Lead sponsor
Singapore General Hospital
Collaborator
Sengkang General Hospital
Collaborator
Source ClinicalTrials.gov