INFILTRATE Study - Work package 2 Implementation & Co-creation
Research type
Research Study
Full title
ImplemeNtation of a Formula low energy diet programme for weight loss In a renaL TRansplAnT sErvice Study - Work package 2 Implementation and Co-creation
IRAS ID
348623
Contact name
Adrian Brown
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106 2024 09 27, Data protection registration
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Obesity affects 25% of UK adults and is associated with chronic kidney disease (CKD) and to kidney failure (KF; previously termed end stage kidney disease), resulting, overtime, in requirement for kidney replacement therapy (dialysis/transplantation).Almost 30,000 UK adults are on dialysis with data showing 39.2% of people with KF live with obesity.
Despite guidelines stating that obesity (body mass index; BMI≥30kg/m2) should not preclude kidney transplantation, but about 30% are excluded. Obesity reduces the likelihood of being listed for and having a transplant, while weight loss increases transplant likelihood.
Evidence suggests that interventions are not appropriately matched to the intended groups, therefore tailoring interventions using implementation science and co-creation are essential, though there is limited evidence available for people with obesity and KF on heamodialysis prior to transplantation.
The overall study aim is to create an implementation blueprint for obesity management in kidneys service in the UK and a co-created obesity management intervention. It split into three work packages (WP); WP1 non-participatory observations, WP2 Implementation science stakeholder workshops, WP3 Co-creation interviews and workshops
WP 1 will use ethnographic study design, using non-participating, non-convert observation of four UK kidney and/or transplant centres within the UK. This will an exploratory ethnographic inquiry into ‘how things are done around here’ and aiming to create a visual map of the patient pathway.
WP 2 will involve using implementation science to identify barriers, faciltators, barrier prioritisation, to help select the implementation strategy for obesity management services and to help the co-design of an obesity intervention to help people living with obesity and kidney failure on haemodialysis to lose weight prior to transplant.
WP 3 will involve a mixture of qualitative approaches including individual interviews and workshops to help to co-design an intervention for obesity management which focusses on the needs of the patients living with obesity and kidney failure on haemodialysis.
REC name
London - Surrey Research Ethics Committee
REC reference
25/PR/0044
Date of REC Opinion
6 Feb 2025
REC opinion
Further Information Favourable Opinion