title: Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial.
abstract: 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. 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.
  
  
  
  We 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.
  
  
  
  This 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.
  
  
  
  This study was registered with the Clinical Trials Registry on 27 August 2014 (ClinicalTrials.org Identifier: NCT02233491 ).
authors.affiliation: Department of Nephrology and Transplantation, Queen Elizabeth Hospital, Birmingham, UK.
authors.forename: Joanne
authors.initials: J
authors.lastname: Wilcox
authors.affiliation: Department of Nephrology and Transplantation, Queen Elizabeth Hospital, Birmingham, UK.
authors.forename: Chantelle
authors.initials: C
authors.lastname: Waite
authors.affiliation: Department of Nutrition and Dietetics, Queen Elizabeth Hospital, Birmingham, UK.
authors.forename: Lyndsey
authors.initials: L
authors.lastname: Tomlinson
authors.affiliation: Department of Nutrition and Dietetics, Queen Elizabeth Hospital, Birmingham, UK.
authors.forename: Joanne
authors.initials: J
authors.lastname: Driscoll
authors.affiliation: Department of Nephrology and Transplantation, Queen Elizabeth Hospital, Birmingham, UK.
authors.forename: Asra
authors.initials: A
authors.lastname: Karim
authors.affiliation: National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Edward
authors.initials: E
authors.lastname: Day
authors.affiliation: Department of Nephrology and Transplantation, Queen Elizabeth Hospital, Birmingham, UK. adnan.sharif@uhb.nhs.uk.|School of Immunology and Inflammation, University of Birmingham, Birmingham, UK. adnan.sharif@uhb.nhs.uk.
authors.forename: Adnan
authors.initials: A
authors.lastname: Sharif
mesh_terms: D064591:Allografts; D001521:Behavior Therapy / Q000379:methods*; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism*; D002985:Clinical Protocols; D000072001:Diet, Healthy; D004739:England; D005081:Exercise Therapy; D018149:Glucose Intolerance / Q000097:blood / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D005951:Glucose Tolerance Test; D006442:Glycated Hemoglobin / Q000378:metabolism; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects; D016030:Kidney Transplantation / Q000009:adverse effects*; D024821:Metabolic Syndrome / Q000097:blood / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D064686:Nutritionists; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D040242:Risk Reduction Behavior; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007166:Immunosuppressive Agents; C517652:hemoglobin A1c protein, human
keywords: Active; Behavioural therapy; Cardiometabolic; Glycaemic metabolism; Kidney transplantation; Lifestyle intervention; Lifestyle modification; Motivation; New-onset diabetes after transplantation; Passive; Post-transplantation diabetes; Weight gain