Specialty: Renal, Primary sub-specialty: Renal Disorders
Conditions
Interventions
Randomisation: The study uses a specialised company that provides randomisation service, which will not involve any members of the research team.
Intervention: The intervention arm involves using a t
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 22/07/2026: Patients will be considered for the study if they meet the following criteria: 1. Adults (18-70 years) 2. Chronic Kidney Disease Stage 5 (KF) on HD 3. Waiting to be listed or listed for renal transplant with obesity identified as the only/main barrier that has precluded listing 4. BMI 32.5-45kg/m2 or BMI 30-45kg/m2 for ethnic minority groups or an increased waist circumference (approximately < 88 cm for women and over < 108 cm for men) 5. Within 15% of their target weight for transplantation 6. Able to comply with study protocol 7. Able to access the internet 8. Able to read and write in English 9. Medically safe to participate in formula LED programme – determined in the opinion of the investigator or clinical team 10. Willing and able to provide written informed consent Previous key inclusion criteria: Patients will be considered for the study if they meet the following criteria: 1. Adults (18-70 years) 2. Chronic Kidney Disease Stage 5 (KF) on HD 3. Waiting to be listed for renal transplant with obesity identified as the only/main barrier that has precluded listing 4. BMI 32.5-45kg/m2 or BMI 30-45kg/m2 for ethnic minority groups or an increased waist circumference (approximately < 88 cm for women and over < 108 cm for men) 5. Within 15% of their target weight for transplantation 6. Weight stable at time of recruitment, defined as <5% variation in dry body weight over the preceding 3 months – including those on obesity management medications, with participants needing to be established for 3 months on maximal tolerated dose and weight stable (e.g. Semaglutide; Tirzepatide). 7. Able to comply with study protocol 8. Able to access the internet 9. Able to read and write in English 10. Medically safe to participate in the formula LED programme – determined in the opinion of the investigator or clinical team 11. Willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 22/07/2026: Patients will be excluded for any of the following reasons: 1. Peritoneal dialysis 2. Contraindication for a low-energy diet programme 3. Diagnosed or known to have uncontrolled depression or psychiatric disorder in the opinion of the investigator or clinical team. 4. Diagnosed with active uncontrolled eating disorder, e.g. binge eating disorder, anorexia nervosa. 5. Previous bariatric surgery. 6. Pregnancy or lactation. 7. Participating in another clinical intervention trial 8. Any diagnosed food allergy, or other allergies which limit the ability to adhere to the intervention diet 9. A current history of drug or alcohol misuse 10. Recurrent persistent pre-dialysis hyperkalaemia (high potassium) >6mmol/L 11. Any other factor making the participant unsuitable in the view of the investigator Previous key exclusion criteria: Patients will be excluded for any of the following reasons: 1. Peritoneal dialysis 2. Contraindication for a low-energy diet programme 3. Diagnosed or known to have uncontrolled depression or psychiatric disorder in the opinion of the investigator or clinical team. 4. Diagnosed with active uncontrolled eating disorder e.g. binge eating disorder, anorexia nervosa. 5. Previous bariatric surgery. 6. Recently started on obesity management medication within the last 3 months or titrating the medication (e.g. Semaglutide; Tirzepatide) and currently losing weight. 7. Pregnancy or lactation. 8. Participating in another clinical intervention trial 9. Any diagnosed food allergy, or other allergies which limit the ability to adhere to the intervention diet 10. A current history of drug or alcohol misuse 11. Recurrent persistent pre-dialysis hyperkalaemia (high potassium) >6mmol/L 12. Any other factor making the participant unsuitable in the view of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment measured using the percentage of participants who are recruited out of the recruitment target at baseline, 3, 6, 9 and 12 months;Retention measured using the percentage of participants followed up at baseline, 3, 6, 9 and 12 months;Completeness of data measured using the number of participants completing follow-up assessments and each outcome measure at baseline, 3, 6, 9 and 12 months;Acceptability measured using the Renal Treatment Satisfaction Questionnaire (RTSQ) at baseline, 3, 6, 9 and 12 months;Acceptability of the intervention measured using a qualitative interview at 3, 6 and 12 months;Diet adherence measured using clinical interviews and use of 24-hour recalls and EPIC Food Frequency Questionnaire at baseline, 3, 6, 9 and 12 months;Mean percentage difference in dry weight change (%) measured using weighing scales at baseline, 3, 6, 9 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Listed for a kidney transplant measured using the number of people activated on the transplant list at baseline, 3, 6, 9 and 12 months;Body composition measured using bioelectrical impedance analysis at baseline, 3, 6, 9 and 12 months;Biochemistry (including lipids, liver, urine and urea, potassium, phosphate) measured using a blood test at baseline, 3, 6, 9 and 12 months;Waist-to-height ratio measured using a tape measure at baseline, 3, 6, 9 and 12 months;Blood pressure measured using a digital sphygmomanometer at baseline, 3, 6, 9 and 12 months;Cardiometabolic risk factors measured using medical records, physical examination and blood tests at baseline, 3, 6, 9 and 12 months;Appetite measured using a Visual Analogue Score (VAS) at baseline, 3, 6, 9 and 12 months;Sleep measured using the actigraph wGT3X-BT at baseline, 3, 6, 9 and 12 months;Activity measured using the actigraph wGT3X-BT and questionnaire at baseline, 3, 6, 9 and 12 months;Physical function measured using a hand dynamometer and sit-to-stand test at baseline, 3, 6, 9 and 12 months;Fatigue measured using the FACIT fatigue scale at baseline, 3, 6, 9 and 12 months;Quality of life measured using the Kidney Disease Quality of Life Short-Form survey (KDQOL SF1.3 MCS) at baseline, 3, 6, 9 and 12 months;Health-related quality of life measured using the EQ-5D at baseline, 3, 6, 9 and 12 months;Mental health measured using the PHQ-4 at baseline, 3, 6, 9 and 12 months;Weight bias measured using the Weight Bias Internalisation Scale at baseline, 3, 6, 9 and 12 months;Eating behaviour measured using the TFEQ and BES at baseline, 3, 6, 9 and 12 months;Dietary Intake measured using 24-hour recalls and EPIC Food Frequency Questionnaire at baseline, 3, 6, 9 and 12 months;Remaining on the kidney transplant list after losing weight measured using the number of participants remaining on the transplant waiting list at baseline, 3, 6, 9 and 12 months | — |
Countries
England, United Kingdom
Contacts
Public ContactAdrian Brown
Outcome results
None listed