title: Fidelity considerations in translational research: Eating As Treatment - a stepped wedge, randomised controlled trial of a dietitian delivered behaviour change counselling intervention for head and neck cancer patients undergoing radiotherapy.
abstract: BACKGROUND
  The confidence with which researchers can comment on intervention efficacy relies on evaluation and consideration of intervention fidelity. Accordingly, there have been calls to increase the transparency with which fidelity methodology is reported. Despite this, consideration and/or reporting of fidelity methods remains poor. We seek to address this gap by describing the methodology for promoting and facilitating the evaluation of intervention fidelity in The EAT (Eating As Treatment) project: a multi-site stepped wedge randomised controlled trial of a dietitian delivered behaviour change counselling intervention to improve nutrition (primary outcome) in head and neck cancer patients undergoing radiotherapy.
  
  
  METHODS
  In accordance with recommendations from the National Institutes of Health Behaviour Change Consortium Treatment Fidelity Workgroup, we sought to maximise fidelity in this stepped wedge randomised controlled trial via strategies implemented from study design through to provider training, intervention delivery and receipt. As the EAT intervention is designed to be incorporated into standard dietetic consultations, we also address unique challenges for translational research.
  
  
  CONCLUSIONS
  We offer a strong model for improving the quality of translational findings via real world application of National Institutes of Health Behaviour Change Consortium recommendations. Greater transparency in the reporting of behaviour change research is an important step in improving the progress and quality of behaviour change research.
  
  
  BACKGROUND
  ACTRN12613000320752 (Date of registration 21 March 2013).
authors.affiliation: Centre for Translational Neuroscience and Mental Health, University of Newcastle, Callaghan, NSW, 2308, Australia. Alison.Beck@newcastle.edu.au.
authors.forename: Alison Kate
authors.initials: AK
authors.lastname: Beck
authors.affiliation: Centre for Translational Neuroscience and Mental Health, University of Newcastle, Callaghan, NSW, 2308, Australia. Amanda.Baker@newcastle.edu.au.
authors.forename: Amanda
authors.initials: A
authors.lastname: Baker
authors.affiliation: Centre for Translational Neuroscience and Mental Health, University of Newcastle, Callaghan, NSW, 2308, Australia. Ben.Britton@hnehealth.nsw.gov.au.
authors.forename: Ben
authors.initials: B
authors.lastname: Britton
authors.affiliation: Department of Radiation Oncology, Calvary Mater Newcastle Hospital, Waratah, NSW, 2308, Australia. Chris.Wratten@calvarymater.org.au.
authors.forename: Chris
authors.initials: C
authors.lastname: Wratten
authors.affiliation: Centre for Dietetics Research, The University of Queensland, St Lucia, QLD, 4072, Australia. j.bauer1@uq.edu.au.
authors.forename: Judith
authors.initials: J
authors.lastname: Bauer
authors.affiliation: School of Medicine & Public Health, The University of Newcastle, Callaghan, NSW, 2308, Australia. Luke.Wolfenden@hnehealth.nsw.gov.au.
authors.forename: Luke
authors.initials: L
authors.lastname: Wolfenden
authors.affiliation: Department of Radiation Oncology, Calvary Mater Newcastle Hospital, Waratah, NSW, 2308, Australia. Gregory.Carter@newcastle.edu.au.
authors.forename: Gregory
authors.initials: G
authors.lastname: Carter
mesh_terms: D000328:Adult; D001521:Behavior Therapy / Q000379:methods*; D002985:Clinical Protocols; D003376:Counseling; D003695:Delivery of Health Care; D005247:Feeding Behavior; D005260:Female; D006258:Head and Neck Neoplasms / Q000175:diagnosis / Q000178:diet therapy* / Q000503:physiopathology / Q000523:psychology / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015596:Nutrition Assessment; D009752:Nutritional Status; D064686:Nutritionists; D012107:Research Design; D013997:Time Factors; D057170:Translational Research, Biomedical / Q000379:methods*; D016896:Treatment Outcome