None listed
Conditions
Brief summary
Kidney transplantation represents optimal treatment for end-stage kidney disease, and leads to improved survival and quality of life compared with dialysis. However, transplant recipients have reduced survival compared with the general population, in large part due to cardiovascular disease. Excessive weight gain, obesity and diabetes are important risk factors for cardiovascular disease and are associated with an increased risk of death and cardiac events in transplant recipients. In the first year following transplantation, there is a significant incidence of excess weight gain and obesity in transplant recipients. These are associated with adverse changes in metabolic parameters, and body composition. Weight gain occurs because of a variety of factors, including immunosuppressive medications, relaxation of dietary restrictions associated with dialysis, and improvements in well-being and appetite. Additionally, many transplant recipients do not engage in adequate levels of physical activity. Non-randomised studies of nutritional interventions early post-transplant have demonstrated reductions in weight gain, with consequent improvements in metabolic parameters. However, to date there is no published evidence from randomised controlled trials. We propose to undertake a randomised controlled trial (RCT) to test the hypothesis that early intensive nutrition intervention, including tailored advice regarding exercise and physical activity, post kidney transplantation will be effective at reducing weight gain in the first year, and leads to improvements in body composition and markers of metabolic risk. This study will help to determine the feasibility of undertaking a larger scale RCT of nutrition interventions to improve glucose tolerance and reduce the incidence of post-transplant diabetes and the risk of cardiovascular events in kidney transplant recipients.
Interventions
Intensive programme over 12 months of nutrition assessment, education and advice from a specialist renal dietitian, commencing in the first month after kidney transplantation. This is in addition to standard post kidney transplant care (see control treatment description). Patients allocated to the intensive nutrition group will see a dietitian fortnightly for the first 3 months post transplant, monthly from 4-6 months, and bi-monthly until 12 months (i.e. a total of 12 visits). These visits will
Intensive programme over 12 months of nutrition assessment, education and advice from a specialist renal dietitian, commencing in the first month after kidney transplantation. This is in addition to standard post kidney transplant care (see control treatment description). Patients allocated to the intensive nutrition group will see a dietitian fortnightly for the first 3 months post transplant, monthly from 4-6 months, and bi-monthly until 12 months (i.e. a total of 12 visits). These visits will last between 30 minutes and 1 hour on each occasion. Nutrition assessment and education will include regular reviews of dietary intake and weight/anthropometry, and advice focusing on: * Energy/caloric intake at an appropriate level to achieve a healthy weight and/or weight loss if overweight or obese * Protein intake to prevent loss of lean muscle mass, i.e. 1.3-1.5g/kg/day in the early period, followed by recommended daily intake of protein for the general population of body weight for males/females for long term stable period * Fat intake to ensure total energy from fat <30-35%; with saturated fat and trans fatty acids <8% * Carbohydrate intake to ensure adequate fibre intake, low glycaemic index foods * Dietary Calcium and ensure vitamin D supplementation use if required * Food safety to ensure dietary requirements are met while food safety precautions are followed * Tailored advice regarding physical activity and exercise, including consultation with an exercise physiologist (approximately 30 minutes at 8 weeks, 12 months and 6 months post-transplant) Adherence to the intervention among participants randomised to this group will be determined using the following measures: * 3-Day food diary - to assess change in dietary habits and adherence to change * Motivational assessment rulers - to assess motivation to change and elicit change (Miller/Rollnick tools) * Patient centred goals - assess if achieved individualised goals * Review patient action plans – review of action steps taken * Patient self goal rating scale based on goal attainment scaling (GAS)
Sponsors
Dr Michael Collins
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult kidney transplant recipients, aged >18 years, who reside and undergo transplant surgery in the Auckland region 2. Willing to participate in all trial procedures for duration of follow-up 3. Written informed consent 4. Stable graft function (as determined by the treating Nephrologist)
Exclusion criteria
1. Severe obesity (BMI >40kg/m2) 2. Underweight (BMI <18.5kg/m2) 3. Evidence of significant malnutrition requiring enteral or parenteral nutrition therapy 4. Ongoing significant medical complications that preclude involvement in the trial (as determined by the treating Nephrologist) 5. Participants who are pregnant, or considered likely to become pregnant during the duration of the trial. Diabetes, cardiovascular disease or other stable medical co-morbidities post-transplant will NOT be exclusions per se.
Outcome results
None listed