Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial

Abstract

BackgroundLifestyle modification is widely recommended to kidney allograft recipients post transplantation due to the cardiometabolic risks associated with immunosuppression including new-onset diabetes, weight gain and cardiovascular events. However, we have no actual evidence that undertaking lifestyle modification protects from any adverse outcomes post transplantation. The aim of this study is to compare whether a more proactive versus passive interventional approach to modify lifestyle is associated with superior outcomes post kidney transplantation.Methods/designWe designed this prospective, single-centre, open-label, randomised controlled study to compare the efficacy of active versus passive lifestyle intervention for kidney allograft recipients early post transplantation. A total of 130 eligible patients, who are stable, nondiabetic and between 3 and 24 months post kidney transplantation, will be recruited. Randomisation is being undertaken by random block permutations into passive (n = 65, leaflet guidance only) versus active lifestyle modification (n = 65, supervised intervention) over a 6-month period. Supervised intervention is being facilitated by two dietitians during the 6-month intervention period to provide continuous lifestyle intervention guidance, support and encouragement. Both dietitians are accredited with behavioural intervention skills and will utilise motivational aids to support study recruits randomised to active intervention. The primary outcome is change in abnormal glucose metabolism parameters after 6 months of comparing active versus passive lifestyle intervention. Secondary outcomes include changes in a wide array of cardiometabolic parameters, kidney allograft function and patient-reported outcome measures. Long-term tracking of patients via data linkage to electronic patient records and national registries will facilitate long-term comparison of outcomes after active versus passive lifestyle intervention beyond the 6-month intervention period.DiscussionThis is the first randomised controlled study to investigate the benefits of active versus passive lifestyle intervention in kidney allograft recipients for the prevention of abnormal cardiometabolic outcomes. In addition, this is the first example of utilising behaviour therapy intervention post kidney transplantation to achieve clinically beneficial outcomes, which has potential implications on many spheres of post-transplant care.Trial registrationThis study was registered with the Clinical Trials Registry on 27 August 2014 (ClinicalTrials.org Identifier: NCT02233491).

Nutrition Trends in Kidney Transplant Recipients: the Importance of Dietary Monitoring and Need for Evidence-Based Recommendations

“…Protocols that are underway or planned reveal strategies to investigate dietary and lifestyle interventions in KTR. A randomized controlled trial in Brittan is investigating the difference of active vs. passive lifestyle intervention on cardiometabolic outcomes of KTR ( 66 ). Similarly, the INTENT trial ( 67 ) randomizes patients at least 1-month post-KT to either standard of care or frequent visits of motivational interviewing techniques with a dietitian and exercise physiologist for 12 months.…”

Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients: A Randomized Controlled Trial

“…Details of the CAVIAR study objectives, design, methods and analysis have been previously reported. 12 Briefly, participants were recruited from a single transplant center and were eligible for inclusion if they were between 3-24 months after kidney transplantation, had no preexisting diabetes and were deemed to have stable kidney function by their transplant clinician. Potential eligible patients were invited to participate by a member of the research team, who assessed eligibility and obtained written informed consent.…”

“…These techniques were combined with two other effective strategies to support the behaviour change intervention; node link mapping (use of visual representation for presenting the intervention) and elements of Social Behaviour and Network Therapy (focus on building social network support for behaviour change). Further details and references are detailed in our CAVIAR methodology paper 12.…”

Frailty Intervention Trial iN End-Stage patientS on haemodialysis (FITNESS): study protocol for a randomised controlled trial

“…There is an urgent need for the development of interventions capable of enacting long-term change within patient groups. Our experience in Birmingham suggests that BCTs can modify behaviour with the potential to change clinical outcomes [ 33 , 44 ]. Therefore, a patient-centred, frailty-specific BCT intervention may be beneficial for frail patients receiving haemodialysis and may improve clinical and patient-reported outcomes.…”