title: Feasibility of an online intervention (STAK-D) to promote physical activity in children with type 1 diabetes: protocol for a randomised controlled trial.
abstract: Regular physical activity has important health benefits for children with type 1 diabetes mellitus (T1DM), yet children and their parents face barriers to participation such as lack of self-efficacy or concerns around hypoglycaemia. Multimedia interventions are useful for educating children about their health and demonstrate potential to improve children's health-related self-efficacy, but few paediatric clinics offer web-based resources as part of routine care. The Steps to Active Kids with Diabetes (STAK-D) programme is an online intervention grounded in psychological theory (social cognitive theory) and informed by extensive preliminary research. The aim of the programme is to encourage and support safe engagement with physical activity for children with T1DM. The aim of this research is to explore the feasibility of delivering the STAK-D programme to children aged 9-12 years with T1DM, and to assess the feasibility of further research to demonstrate its clinical and cost-effectiveness.
  
  
  
  Up to 50 children aged 9-12 years with T1DM and their parents will be recruited from two paediatric diabetes clinics in the UK. Child-parent dyads randomised to the intervention group will have access to the intervention website (STAK-D) and a wrist-worn activity monitor for 6 months. The feasibility of intervention and further research will be assessed by rate of recruitment, adherence, retention, data completion and adverse events. Qualitative interviews will be undertaken with a subsample of children and parents (up to 25 dyads) and health care professionals (up to 10). Health outcomes and the feasibility of outcome measurement tools will be assessed. These include self-efficacy (CSAPPA), objective physical activity, self-reported physical activity (PAQ), fear of hypoglycaemia (CHFS; PHFS), glycaemic control (HbA1c), insulin dose, Body Mass Index (BMI), health-related quality of life (CHU9D; CHQ-PF28), health service use and patient-clinician communication. Assessments will be taken at baseline (T0), 8 weeks (T1) and at 6-month follow-up (T2).
  
  
  
  The goal of this feasibility trial is to assess the delivery of STAK-D to promote physical activity among children with T1DM, and to assess the potential for further, definitive research to demonstrate its effectiveness. Results will provide the information necessary to design a larger randomised controlled trial and maximise the recruitment rate, intervention delivery and trial retention.
  
  
  
  ISRCTN, ISRCTN48994721 . Registered on 28 October 2016.
authors.affiliation: University of Nottingham School of Health Sciences, A Floor, Queen's Medical Centre, Nottingham, NG7 2HA, UK. holly.blake@nottingham.ac.uk.
authors.forename: Holly
authors.identifier: 0000-0003-3080-2306
authors.initials: H
authors.lastname: Blake
authors.affiliation: University of Nottingham School of Health Sciences, A Floor, Queen's Medical Centre, Nottingham, NG7 2HA, UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Quirk
authors.affiliation: University of Nottingham School of Medicine, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Leighton
authors.affiliation: Department of Paediatric Endocrinology and Diabetes, Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust, Nottingham, NG7 2UH, UK.
authors.forename: Tabitha
authors.initials: T
authors.lastname: Randell
authors.affiliation: Children's Hospital, Leicester Royal Infirmary, Children's Diabetes and Endocrinology, Infirmary Square, Leicester, LE1 5WW, UK.
authors.forename: James
authors.initials: J
authors.lastname: Greening
authors.affiliation: Institute of Mental Health, Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.
authors.forename: Boliang
authors.initials: B
authors.lastname: Guo
authors.affiliation: Institute of Mental Health, B Floor, Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.
authors.forename: Cris
authors.initials: C
authors.lastname: Glazebrook
mesh_terms: D056044:Actigraphy / Q000295:instrumentation; D000367:Age Factors; D002648:Child; D002652:Child Behavior; D002985:Clinical Protocols; D003922:Diabetes Mellitus, Type 1 / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D015444:Exercise; D005240:Feasibility Studies; D005260:Female; D000072936:Fitness Trackers; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006293:Health Promotion / Q000379:methods*; D006304:Health Status; D000070497:Healthy Lifestyle; D006801:Humans; D020407:Internet; D008297:Male; D010349:Patient Compliance; D012107:Research Design; D020377:Self Efficacy; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
keywords: Children; Feasibility; Intervention; Physical activity; Protocol; Self-efficacy; Type 1 diabetes