title: The effect of intensive nutrition interventions on weight gain after kidney transplantation: protocol of a randomised controlled trial.
abstract: BACKGROUND
  Weight gain and obesity are common after kidney transplantation, particularly during the first year. Obesity is a risk factor for the development of new-onset diabetes after transplantation, and is associated with reduced graft survival. There is a lack of evidence for effective interventions to prevent weight gain after kidney transplantation.
  
  
  METHODS
  The effect of INTEnsive Nutrition interventions on weight gain after kidney Transplantation (INTENT) trial is a single-blind (outcomes assessor), randomised controlled trial to assess the effect of intensive nutrition interventions, including exercise advice, on weight gain and metabolic parameters in the first year after transplantation. Participants will be randomised during the first post-transplant month to either standard care (four visits with a renal dietitian over twelve months) or intensive nutrition intervention (eight visits with a renal dietitian over the first six months, four visits over the second six months, and three visits over the first six months with an exercise physiologist). In the intensive intervention group, nutrition counselling will be provided using motivational interviewing techniques to encourage quality engagement. Collaborative goal setting will be used to develop personalised nutrition care plans. Individualised advice regarding physical activity will be provided by an exercise physiologist. The primary outcome of the study is weight at six months after transplant, adjusted for baseline (one month post-transplant) weight, obesity and gender. Secondary outcomes will include changes in weight and other anthropometric measures over 12 months, body composition (in vivo neutron activation analysis, total body potassium, dual-energy X-ray absorptiometry, and bioelectrical impedance), biochemistry (fasting glucose, lipids, haemoglobin A1c and insulin), dietary intake and nutritional status, quality of life, and physical function.
  
  
  CONCLUSIONS
  There are currently few randomised clinical trials of nutrition interventions after kidney transplantation. The INTENT trial will thus provide important data on the effect of intensive nutrition interventions on weight gain after transplant and the associated metabolic consequences. Additionally, by assessing changes in glucose metabolism, the study will also provide data on the feasibility of undertaking larger multi-centre trials of nutrition interventions to reduce the incidence or severity of diabetes after transplantation.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry Number: ACTRN12614000155695.
authors.forename: Kristin J
authors.initials: KJ
authors.lastname: Ryan
authors.forename: Jessie M Segedin
authors.initials: JM
authors.lastname: Casas
authors.forename: Laura E
authors.initials: LE
authors.lastname: Mash
authors.forename: Sandra L
authors.initials: SL
authors.lastname: McLellan
authors.forename: Lyn E
authors.initials: LE
authors.lastname: Lloyd
authors.forename: James W
authors.initials: JW
authors.lastname: Stinear
authors.forename: Lindsay D
authors.initials: LD
authors.lastname: Plank
authors.affiliation: Department of Renal Medicine, Auckland City Hospital, Auckland District Health Board, Private Bag 92024, Auckland 1142, New Zealand. michael.collins@adhb.govt.nz.
authors.forename: Michael G
authors.initials: MG
authors.lastname: Collins
mesh_terms: D061345:Early Medical Intervention / Q000379:methods* / Q000639:trends; D005260:Female; D006801:Humans; D016030:Kidney Transplantation / Q000009:adverse effects* / Q000639:trends; D008297:Male; D015596:Nutrition Assessment; D018673:Nutrition Policy / Q000639:trends; D009765:Obesity / Q000178:diet therapy* / Q000209:etiology / Q000517:prevention & control; D010353:Patient Education as Topic / Q000379:methods / Q000639:trends; D012307:Risk Factors; D016037:Single-Blind Method; D016896:Treatment Outcome; D015430:Weight Gain / Q000502:physiology