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).
Highlights
Lifestyle 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
We have previously demonstrated the successful use of active lifestyle modification in the setting of kidney transplantation [12]
Despite the importance of Post-transplantation diabetes mellitus (PTDM) as a cause of morbidity, mortality, increased cost and patient anxiety, there is a paucity of randomised controlled trials exploring interventions that can attenuate the development of diabetes in a metabolically high-risk cohort like kidney allograft recipients
Summary
Lifestyle 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. Strategies to attenuate this high risk for developing PTDM (and other cardiometabolic risk factors such as weight gain, hyperlipidaemia and hypertension) should be actively pursued after kidney transplantation to prevent adverse long-term outcomes, evidence that providing this advice improves clinical outcomes is lacking. Lindstrom et al demonstrated a reduced hazard ratio of 0.57 (95 % confidence interval 0.43–0.76, p = 0.00001) secondary to lifestyle intervention [7] In this latter study the beneficial changes persisted after discontinuation of the intervention. Recent data has confirmed that lifestyle intervention is associated with a reduced hazard ratio of 0.73 (95 % confidence interval 0.65–0.83, p < 0.0001) in diabetes incidence during a mean follow-up of 15 years after participation in the 3-year Diabetes Prevention Programme [8], attenuating concern regarding long-term sustainability beyond interventional study periods
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