title: Comparison of active treatments for impaired glucose regulation: a Salford Royal Foundation Trust and Hitachi collaboration (CATFISH): study protocol for a randomized controlled trial.
abstract: Diabetes is highly prevalent and contributes to significant morbidity and mortality worldwide. Behaviour change interventions that target health and lifestyle factors associated with the onset of diabetes can delay progression to diabetes, but many approaches rely on intensive one-to-one contact by specialists. Health coaching is an approach based on motivational interviewing that can potentially deliver behaviour change interventions by non-specialists at a larger scale. This trial protocol describes a randomized controlled trial (CATFISH) that tests whether a web-enhanced telephone health coaching intervention (IGR3) is more acceptable and efficient than a telephone-only health coaching intervention (IGR2) for people with prediabetes (impaired glucose regulation).
  
  
  
  CATFISH is a two-parallel group, single-centre individually randomized controlled trial. Eligible participants are patients aged ≥18 years with impaired glucose regulation (HbA1c concentration between 42 and 47 mmol/mol), have access to a telephone and home internet and have been referred to an existing telephone health coaching service at Salford Royal NHS Foundation Trust, Salford, UK. Participants who give written informed consent will be randomized remotely (via a clinical trials unit) to either the existing pathway (IGR2) or the new web-enhanced pathway (IGR3) for 9 months. The primary outcome measure is patient acceptability at 9 months, determined using the Client Satisfaction Questionnaire. Secondary outcome measures at 9 months are: cost of delivery of IGR2 and IGR3, mental health, quality of life, patient activation, self-management, weight (kg), HbA1c concentration, and body mass index. All outcome measures will be analyzed on an intention-to-treat basis. A qualitative process evaluation will explore the experiences of participants and providers with a focus on understanding usability of interventions, mechanisms of behaviour change, and impact of context on delivery and user acceptability. Qualitative data will be analyzed using Framework.
  
  
  
  The CATFISH trial will provide a pragmatic assessment of whether a web-based information technology platform can enhance acceptability of a telephone health coaching intervention for people with prediabetes. The data will prove critical in understanding the role of web applications to improve engagement with evidence-based approaches to preventing diabetes.
  
  
  
  ISRCTN16534814 . Registered on 7 February 2016.
authors: Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, YO10 5DD, UK. peter.coventry@york.ac.uk.
authors: Peter A
authors: PA
authors: Coventry
authors: NIHR School for Primary Care Research and Manchester Academic Health Science Centre, University of Manchester, Manchester, M13 9PL, UK.
authors: Peter
authors: P
authors: Bower
authors: NIHR School for Primary Care Research and Manchester Academic Health Science Centre, University of Manchester, Manchester, M13 9PL, UK.
authors: Amy
authors: A
authors: Blakemore
authors: NIHR School for Primary Care Research and Manchester Academic Health Science Centre, University of Manchester, Manchester, M13 9PL, UK.
authors: Liz
authors: L
authors: Baker
authors: Centre for Biostatistics and Manchester Academic Health Science Centre, University of Manchester, Manchester, M13 9PL, UK.
authors: Mark
authors: M
authors: Hann
authors: Salford Royal NHS Foundation Trust, Salford, M6 8HD, UK.
authors: Angela
authors: A
authors: Paisley
authors: Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, YO10 5DD, UK.
authors: Charlotte
authors: C
authors: Renwick
authors: Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, YO10 5DD, UK.
authors: Jinshuo
authors: J
authors: Li
authors: Information Systems Group, Hitachi Europe Limited, London, NW1 5DH, UK.
authors: Atushi
authors: A
authors: Ugajin
authors: Salford Royal NHS Foundation Trust, Salford, M6 8HD, UK.
authors: Martin
authors: M
authors: Gibson
mesh_terms: D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003376:Counseling / Q000191:economics / Q000379:methods*; D004739:England; D006442:Glycated Hemoglobin / Q000378:metabolism; D017048:Health Care Costs; D007722:Health Knowledge, Attitudes, Practice; D006304:Health Status; D006801:Humans; D057194:Intention to Treat Analysis; D020407:Internet; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D011236:Prediabetic State / Q000097:blood / Q000191:economics / Q000523:psychology / Q000628:therapy*; D011788:Quality of Life; D012107:Research Design; D012648:Self Care / Q000191:economics / Q000379:methods*; D011795:Surveys and Questionnaires; D013689:Telephone; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human