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Trial registered on ANZCTR


Registration number
ACTRN12614000155695
Ethics application status
Approved
Date submitted
17/12/2013
Date registered
10/02/2014
Date last updated
23/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Intensive Nutrition Interventions after Kidney Transplantation
Scientific title
The INTENT trial: The effect of intensive nutrition interventions on weight gain after kidney transplantation - a randomised controlled trial
Secondary ID [1] 283790 0
None
Universal Trial Number (UTN)
U1111-1148-6077
Trial acronym
The INTENT trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney transplantation 290766 0
Weight gain 290767 0
Obesity 290768 0
End-stage kidney disease 290769 0
Condition category
Condition code
Renal and Urogenital 291131 291131 0 0
Kidney disease
Diet and Nutrition 291132 291132 0 0
Obesity
Inflammatory and Immune System 291133 291133 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 288475 0
Prevention
Intervention code [2] 288754 0
Lifestyle
Intervention code [3] 288755 0
Behaviour
Comparator / control treatment
Standard care post kidney transplant, including all routine medical and surgical care, including immunosuppression, monitoring and prophylaxis of infection.

As part of standard care, transplant recipients are offered reviews by a dietitian at 1, 3 and 12 months post-transplant. Dietitians provide education and advice in line with standard practice and post-transplant care.
Control group
Active

Outcomes
Primary outcome [1] 291116 0
Change in weight (kg) between baseline and 6 months after kidney transplant
Timepoint [1] 291116 0
Baseline, 6 months
Secondary outcome [1] 306017 0
Change in weight and anthropometry measures post transplant:
* Weight (kg)
* Body mass index (kg/m2)
* Waist-hip circumference ratio
* Seated blood pressure
* Mid arm circumference
* Skin fold thickness
Timepoint [1] 306017 0
Baseline, 3, 6, and 12 months
Secondary outcome [2] 306018 0
Change in body composition parameters post-transplant:
* Deuterium measurement analysis to determine total body water
* Dual energy X-ray absorptometry (DEXA) to determine bone mass and fat mass
* In vivo neutron activation analysis to determine total body protein
* Total body potassium analysis to assess body cell mass
* Bioelectrical impedence as surrogate measure of total body water, extracellular water, fat mass and lean body mass
Timepoint [2] 306018 0
Baseline, 3, 6, and 12 months
Secondary outcome [3] 306019 0
Change in biochemical measures post-transplant:
* Serum creatinine, full blood count, electrolytes, calcium, phosphate and liver enzymes (non blinded)
* Immunosuppression drug levels (non blinded)
* Fasting glucose
* Fasting insulin and determination of homeostatic model assessment index of insulin resistance (HOMA)
* Haemoglobin A1c
* Serum cholesterol and triglycerides
Timepoint [3] 306019 0
Baseline, 3, 6, and 12 months
Secondary outcome [4] 306020 0
Level of physical activity and physical functional capacity post-transplant:
* Physical activity questionnaire
* Six metre gait assessment (maximum walking speed over a 6 metre distance)
* Hand grip strength (dynamometry)
* Sit to stand to sit test (lower extremity strength)
Timepoint [4] 306020 0
Baseline, 3, 6, and 12 months
Secondary outcome [5] 306021 0
Quality of life as measured using the (short-form 36 (SF-36) questionnaire
Timepoint [5] 306021 0
Baseline, 3, 6, and 12 months
Secondary outcome [6] 306022 0
Adherence to dietary advice post-transplant will be assessed in the intensive intervention group 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)
Timepoint [6] 306022 0
3, 6, and 12 months
Secondary outcome [7] 306037 0
Validity of bio-electrical impedance assessment as compared with gold standard body composition analysis in kidney transplant recipients
Timepoint [7] 306037 0
Baseline, 3, 6, and 12 months
Secondary outcome [8] 306039 0
Cost-effectiveness analysis of intensive nutrition interventions versus standard of care to reduce weight gain after kidney transplantation
Timepoint [8] 306039 0
6 months, 12 months
Secondary outcome [9] 307479 0
The difference in HbA1c between the groups will be used to determine the feasibility of undertaking a larger trial of nutrition interventions to improving glucose tolerance and reduce new-onset diabetes after transplant (NODAT).
Timepoint [9] 307479 0
12 months

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised 1:1 to receive either intensive nutrition intervention or standard of care. Randomisation will be stratified by gender, and performed externally by a statistical consultant. Allocation concealment will be via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequence allocation, using permuted blocks of variable sizes stratified by gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome (body weight at 6 months post-transplant) will be compared between the groups using an analysis of covariance (ANCOVA) adjusted for baseline weight, baseline obesity (BMI < or > 30 kg/m2), and gender. The extent of weight gain after transplant has been shown be significantly affected by baseline BMI [Orazio L et al. J Ren Care 2014, 40(2):99-106]; gender will be included as a covariate due to its use as a stratification variable in the randomisation.

Secondary analyses will include analyses of change in anthropometry (BMI, waist circumference, and waist-hip ratio), physical function, body composition, quality of life, and biochemistry parameters between the groups, using ANCOVA with adjustment for relevant baseline covariates. Repeated measures analyses using linear mixed models with multiple covariates will be used to compare changes in weight, anthropometry, physical function, body composition, quality of life, and biochemistry parameters over time (baseline, 3, 6 and 12 months) between the groups. Multiple linear regression will be used to identify significant predictors other than group allocation associated with these changes. Variables identified as significant will be analysed with pairwise comparisons.

Comparisons between groups for differences in variables of interest will be conducted using Fisher’s exact test for categorical variables, unpaired t tests for parametric variables, and Wilcoxon rank sum tests for non-parametric variables.

All statistical analyses will be performed using appropriate statistical software, such as STATA or SAS. The level of statistical significance will be set at probability level of <0.05.


Calculation of required sample size

Using Stata statistical software to model an ANCOVA analysis of the primary outcome at six months, with power of 80% and alpha level of 5%, we estimate that 14 participants will be required per group, i.e. 28 in total. To account for dropouts, we aim to recruit up to 32 participants into the study. The effect size was estimated as a weight difference of 5 kg at 6 months between the groups, 74 kg (SD 9 kg) in the standard group and 69 kg (SD 12kg) in the intervention group. These estimates reflect data from a non-randomised study of intensive nutrition interventions versus standard care in a comparable population of kidney transplant recipients whose weights were similar at baseline [Patel MG et al. J Ren Nutr 1998; 8: 137-41]. The correlation between weight at baseline and 6 months was estimated as 0.9, based on data showing a mean difference in weight of 3.2 kg (SD 5.9 kg) between 1 and 6 months of 1299 kidney transplant recipients who received their kidney transplant in Auckland between 1991 and 2012 (unpublished observations, data on file), where the correlation was 0.9514. Similar findings were found in an analysis of weight change post-transplant in a comparable population of 156 transplant recipients in Brisbane, Australia (mean weight change 3.3 kg, SD 6.0 kg) (Campbell KL, personal communication) [Orazio L et al. J Ren Care 2014, 40(2):99-106].

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2014
Actual
28/03/2014
Date of last participant enrolment
Anticipated
31/12/2014
Actual
31/07/2015
Date of last data collection
Anticipated
Actual
31/08/2016
Sample size
Target
32
Accrual to date
Final
37
Recruitment outside Australia
Country [1] 5687 0
New Zealand
State/province [1] 5687 0
Auckland region

Funding & Sponsors
Funding source category [1] 288449 0
Charities/Societies/Foundations
Name [1] 288449 0
Auckland District Health Board Charitable Trust
Country [1] 288449 0
New Zealand
Funding source category [2] 288450 0
Charities/Societies/Foundations
Name [2] 288450 0
Australian and New Zealand Society of Nephrology
Country [2] 288450 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Collins
Address
Department of Renal Medicine
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 287153 0
Hospital
Name [1] 287153 0
Auckland District Health Board
Address [1] 287153 0
Private Bag 92024
Auckland 1142
Country [1] 287153 0
New Zealand
Other collaborator category [1] 277735 0
Individual
Name [1] 277735 0
Associate Professor Lindsay Plank
Address [1] 277735 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland
Country [1] 277735 0
New Zealand
Other collaborator category [2] 277736 0
Individual
Name [2] 277736 0
Ms Lyn Lloyd
Address [2] 277736 0
Nutrition Services
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country [2] 277736 0
New Zealand
Other collaborator category [3] 277737 0
Individual
Name [3] 277737 0
Ms Jessie Casas
Address [3] 277737 0
Nutrition Services
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country [3] 277737 0
New Zealand
Other collaborator category [4] 277738 0
Individual
Name [4] 277738 0
Ms Laura Mash
Address [4] 277738 0
Nutrition Services
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country [4] 277738 0
New Zealand
Other collaborator category [5] 277739 0
Individual
Name [5] 277739 0
Ms Kristin Ryan
Address [5] 277739 0
Discipline of Nutrition
University of Auckland
Private Bag 92019
Auckland
Country [5] 277739 0
New Zealand
Other collaborator category [6] 277813 0
Individual
Name [6] 277813 0
Ms Sandra McLellan
Address [6] 277813 0
Nutrition Service
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country [6] 277813 0
New Zealand
Other collaborator category [7] 277907 0
Individual
Name [7] 277907 0
Dr James Stinear
Address [7] 277907 0
Department of Sports and Exercise Science
University of Auckland
Private Bag 92019
Auckland 1142
Country [7] 277907 0
New Zealand
Other collaborator category [8] 280091 0
Individual
Name [8] 280091 0
Ms Cordula Henggeler
Address [8] 280091 0
Discipline of Nutrition University of Auckland Private Bag 92019 Auckland
Country [8] 280091 0
New Zealand
Other collaborator category [9] 280092 0
Individual
Name [9] 280092 0
Ms Emily Gilchrist
Address [9] 280092 0
Discipline of Nutrition University of Auckland Private Bag 92019 Auckland
Country [9] 280092 0
New Zealand
Other collaborator category [10] 280093 0
Individual
Name [10] 280093 0
Ms Jennifer Robb
Address [10] 280093 0
Nutrition Services Auckland City Hospital Private Bag 92024 Auckland 1142
Country [10] 280093 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290322 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 290322 0
Ministry of Health
C/ MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
Ethics committee country [1] 290322 0
New Zealand
Date submitted for ethics approval [1] 290322 0
17/12/2013
Approval date [1] 290322 0
12/02/2014
Ethics approval number [1] 290322 0
14/NTB/8

Summary
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.
Trial website
Trial related presentations / publications
PUBLICATIONS

Trial Protocol
Ryan KJ et al. The effect of intensive nutrition interventions on weight gain after kidney transplantation: protocol of a randomised controlled trial. BMC Nephrology 2014; 15: 148. URL: http://www.biomedcentral.com/1471-2369/15/148

Main results paper
Henggeler CK et al. A Randomized Controlled Trial of an Intensive Nutrition Intervention Versus Standard Nutrition Care to Avoid Excess Weight Gain After Kidney Transplantation: The INTENT Trial. J Ren Nutr. 2018 May 2. pii: S1051-2276(18)30062-1. doi: 10.1053/j.jrn.2018.03.001. [Epub ahead of print]
URL: https://www.jrnjournal.org/article/S1051-2276(18)30062-1/fulltext
Public notes
Attachments [1] 191 191 0 0
/AnzctrAttachments/365503-Study Protocol - Ryan KJ et al 2014 BMC Nephrology.pdf
Attachments [2] 2745 2745 0 0
/AnzctrAttachments/365503-Henggeler_2018_J_Ren_Nutr.pdf (Publication)

Contacts
Principal investigator
Name 45070 0
Dr Michael Collins
Address 45070 0
Department of Renal Medicine
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 45070 0
New Zealand
Phone 45070 0
+64 9 3797440
Fax 45070 0
+64 9 3074987
Email 45070 0
[email protected]
Contact person for public queries
Name 45071 0
Michael Collins
Address 45071 0
Department of Renal Medicine
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 45071 0
New Zealand
Phone 45071 0
+64 9 3797440
Fax 45071 0
+64 9 3074987
Email 45071 0
[email protected]
Contact person for scientific queries
Name 45072 0
Michael Collins
Address 45072 0
Department of Renal Medicine
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 45072 0
New Zealand
Phone 45072 0
+64 9 3797440
Fax 45072 0
+64 9 3074987
Email 45072 0
[email protected]

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