INFILTRATE: ImplemeNtation of a Formula low energy diet programme for weight loss In a renaL TRansplAnT sErvice Study - Work package 3 Feasibility Study
Specialty: Renal, Primary sub-specialty: Renal Disorders; Health Category: Renal and Urogenital; Disease/Condition: Obesity and other hyperalimentation, Renal failure
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 total diet replacement (TDR) formula LED behavioural programme, including structured physical activity, psychological and peer support. Diet: Participants in the intervention arm will receive a total diet replacement low-energy formula-based diet for 12 weeks, providing ~850kcal/day and then will have gradual food reintroduction over 8 weeks from 1000kcal/day to 1200kcal/day and then a maintenance phase. Participants will receive individualised dietary advice based on the dietary guidelines for haemodialysis patients and tailored to the individual to achieve weight maintenance. Physical activity: Participants in the intervention arm will be encouraged to engage in regular physical activity. Each participant will be encouraged to accumulate 150 min per week of moderate intensity aerobic activity or 75 min per week of vigorous activity, and to do muscle resistance training on 2 days of the week. In additional they will get access to a 12-week health coach-led physical activity programme. Psychology: Participants in the intervention arm will have access to psycho-educational material and monthly groups, alongside a peer support group on a monthly basis. Control (usual care): Participants in the control group will attend usual kidney clinic visits with treatment and receive standard care. There will be no change to the frequency of usual nephrologist care, dietitian, other kidney team, or general practitioner shared care monitoring.
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.
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