CAVIAR - RCT of lifestyle intervention post kidney transplantation
Research type
Research Study
Full title
A prospective randomised controlled trial comparing glycaemic benefits of active versus passive lifestyle intervention in kidney allograft recipients
IRAS ID
156933
Contact name
Adnan Sharif
Contact email
Sponsor organisation
University Hospitals Birmingham NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
New-onset diabetes is a common problem after receiving a kidney transplant, developed by nearly a third of kidney transplant patients within the first year post-transplant, but all patients have a long-term increased risk in comparison to the general population. The risk for developing post-transplantation diabetes mellitus (PTDM) is related to both general and transplant-specific risk factors. In addition, kidney transplant recipients have increased risk for hypertension, hyperlipidaemia and weight gain (the latter in >50% of all kidney transplant patients within the first year post-transplant). These risk factors all contribute to cardiovascular disease being the commonest cause of death after kidney transplantation.
In the general population lifestyle intervention has been shown to reduce the risk of diabetes but no similar work has ever been done in the kidney transplant population. This would be important to show specifically in the transplant population and not to simply translate data from the general population. This is important as PTDM is different from type 2 diabetes mellitus and evidence-base cannot be translated from general to transplant populations.
This study is a randomised controlled trial comparing standard-of-care (verbal and leaflet advice on lifestyle modifications) versus a more intensive and active approach to lifestyle intervention post kidney transplantation (n=65 per arm). In the active arm, patients will receive dedicated time with a dietician (trained to deliver effective psychosocial intervention) who will review diet, exercise and encourage weight loss. Patients will receive three prospective dietiican-led assessments.
All patients will receive metabolic assessment before and after intervention to determine the safety and efficacy of active versus passive lifestyle intervention post kidney transplantation. If found to be successful, it will support integration of allied health professionals into an integrated approach to pursue active lifestyle intervention techniques for all kidney transplant patients.
Lay summary of study results:
What was the purpose of the study?
People who have received a kidney transplant have a higher risk for diabetes and weight gain compared to the general public. One of the risk-factors is the need for lifelong anti-rejection medications. Lifestyle changes like healthy diet and exercise, have shown a beneficial effect in reducing the risk of developing diabetes in the general public. The CAVIAR study was developed to find out if the same benefits apply to people who have received a kidney transplant.
Main aims of the study:
1. Do healthy lifestyle changes improve the glucose metabolism and decrease the number of people developing diabetes after transplantation?
2. Do healthy lifestyle changes improve other health indicators (weight, body fat mass, etc.) 3. Is it more effective to have a renal dietitian help with healthy lifestyle changes rather than just being given written information?How was the study set up?
From the QEHB kidney transplantation clinic 130 people signed up for this study and were divided equally into two groups:
• First group (active intervention): the renal dietitian consultation group received four face to face visits and two phone calls with the renal dietitian, as well as three visits with a research nurse. The dietitian consultations focused on healthy diet and exercise advice supported by behaviour change techniques.
• Second group (passive intervention): the leaflet-based advice group received three visits with a renal research nurse only and no dietitian input. Healthy lifestyle advice was leaflet-based. The leaflet was provided to patients in hospital at the time of receiving the transplant.
Study follow up period for all participants was 6 months. Long-term data collection through Electronic Patient Records for 5 years.What are the results of the study?
1. No difference was seen in glucose metabolism in both groups. However, those who were in the dietitian consultation group developed 50% fewer episodes of diabetes.
2. In the dietitian consultation group there were significant beneficial changes in weight and body fat mass: an average weight loss was 2.5kg and 1.5kg in body fat mass.
3. Renal dietitian-led lifestyle change consultations were well accepted by the participants.Key messages
• Healthy lifestyle changes can be encouraged after receiving a kidney transplant.
• Promoting healthy diet and exercise in people after kidney transplant leads to:
- improved weight control.
- fewer events of diabetes after transplantation which in the long-term can help to prevent heart disease.
• The renal dietitians trained in behavioural change techniques can deliver support to people after kidney transplant that leads to healthy lifestyle choices and help to prevent the development of diabetes.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
14/WM/1245
Date of REC Opinion
5 Dec 2014
REC opinion
Further Information Favourable Opinion