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Feasibility of an online intervention (STAK-D) to promote physical activity in children with type 1 diabetes: protocol for a randomised controlled trial

Blake, Holly; Quirk, Helen; Leighton, Paul; Randell, Tabitha; Greening, James; Guo, Boliang; Glazebrook, Cris

Authors

Helen Quirk

PAUL LEIGHTON PAUL.LEIGHTON@NOTTINGHAM.AC.UK
Associate Professor of Applied Health Services Research

Tabitha Randell

James Greening



Abstract

Background: 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.
Methods: 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).
Discussion: 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.

Citation

Blake, H., Quirk, H., Leighton, P., Randell, T., Greening, J., Guo, B., & Glazebrook, C. (2016). Feasibility of an online intervention (STAK-D) to promote physical activity in children with type 1 diabetes: protocol for a randomised controlled trial. Trials, 17(283), https://doi.org/10.1186/s13063-016-1719-0

Journal Article Type Article
Acceptance Date Oct 22, 2016
Publication Date Dec 8, 2016
Deposit Date Dec 16, 2016
Publicly Available Date Dec 16, 2016
Journal Trials
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 17
Issue 283
DOI https://doi.org/10.1186/s13063-016-1719-0
Keywords Type 1 diabetes, Children, Self-efficacy, Physical activity, Intervention, Feasibility, Protocol
Public URL http://eprints.nottingham.ac.uk/id/eprint/39402
Publisher URL http://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1719-0
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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