Title: SKIP [Supporting Kids with diabetes In Physical activity]: feasibility of an online multimedia intervention to promote physical activity in children with type 1 diabetes (T1DM)
Funder: Department of Health and Social Care

Abstract: Background: Low levels of physical activity are common in children with type 1 diabetes (T1DM). This has negative implications for diabetes control, physical and psychological health across the lifecourse, and is costly to the NHS. Children, parents and healthcare professionals hold positive attitudes towards physical activity promotion, but highlight barriers to being active which included low self-efficacy (or confidence) for exercise and fear of hyperglycaemia. Children with T1DM are comfortable with and prefer electronic media and parents are receptive to the use of technology as part of diabetes management. However, online resources are not currently used as part of routine care. Clinicians support the introduction of technology-based resources into clinical care, but have identified a lack of evidence-based resources which are condition and age-appropriate. We have developed an online multimedia intervention (SKIP) to promote physical activity in children aged 9-12 with T1DM, which is underpinned by psychological behaviour change theory and best available evidence. We hypothesise that SKIP will increase physical activity through building self-efficacy for exercise and reducing fear of hyperglycaemia. Aim: The main aim of this study is to establish the feasibility of doing a definitive trial to investigate the clinical and cost-effectiveness of SKIP. The definitive trial will be deemed feasible if we can demonstrate that we can successfully identify and recruit patients with T1DM and the proposed study design is deemed acceptable by patients, parents and clinicians. Our objectives include: Assessing the feasibility and acceptability of recruitment strategies, randomisation, methods of data collection and outcome measures to be used in the future trial, Determining rates of adherence and compliance, study retention and drop-out (with reasons) Assess acceptability of SKIP to children, parents and health care professionals Finalise the design of a future randomised controlled trial including revision of SKIP and assessment of long-term delivery costs. Plan of investigation: The procedure is divided into three parts: [1] randomised feasibility study; SKIP consists of education and interactive elements aimed at improving knowledge of exercise and T1DM, and a mechanism for recording and monitoring blood glucose and physical activity. Children will receive wrist-worn motion sensors to support goal setting and monitoring. We will recruit 50 child/parent dyads from two hospital sites over 10 months. 25 will receive SKIP, 25 will receive usual care only. Objective monitoring data will be collected to determine intervention fidelity, participant engagement with the intervention and the research study. We will test collection of measures at baseline, 8 weeks and 6 months. This will include clinical indicators of diabetes control, anthropometric, behavioural, and psychological variables, communication between health care teams, patients and families, and economic outcomes; [2] qualitative evaluation; we will invite SKIP participants (children and parents) and key healthcare professionals involved in their care to participate in qualitative interviews to give feedback and evaluation of intervention content and delivery, and research processes; [3] Trial development; we will finalise SKIP specification and costs, and research procedures, methods and measures based on feasibility and acceptability testing. We will develop and test measures for assessing healthcare communication and economic outcomes in the main trial. Potential benefits to patients/NHS: Improved self-efficacy for exercise and reduced fear of hypoglycaemia will lead to increased physical activity in childhood which can be sustained across the lifecourse. This will lead to better diabetes control. Supporting clinical staff in promoting physical activity may improve communication between healthcare teams, children and their families. Better diabetes control (and general health) may in the long-term reduce NHS costs and improve educational and social outcomes through reducing unecessary illness, hospital visits and healthcare utilisation; all to be assessed in the future trial.

Lay abstract: Being active is essential for diabetes management and lifelong health, but many children with type 1 diabetes (T1DM) do not adhere to exercise recommendations. We have conducted reviews of the published evidence, and interviewed children, parents and healthcare professionals. This has indicated that clinical staff view physical activity as important, but they identify a lack of age-appropriate evidence-based resources for their patients. Children may lack confidence in their ability to be active which is essential for developing exercise habits that will be sustained over time; children and parents may have a fear of hypoglycaemia associated with exercise. Face-to-face interventions can be effective but costly to deliver, less convenient for familes and potentially have long waiting lists. Parents and clinic staff suggested an online package. Research shows that children with T1DM are comfortable with and prefer electronic media and their parents are receptive to the use of technology as part of diabetes management, but appropriate online resources are not currently available within routine care. We have created an online programme called SKIP (Supporting Kids with Diabetes In Physical Activity). This interactive programme promotes safe physical activity through building confidence, reducing barriers to exercise, and encouraging children (and their parents) to set achievable goals, record and monitor their own physical activity. We will recruit 50 children (and parents) aged 9-12 years with T1DM. Half the group will receive the intervention and half will receive usual care. We will collect data after 8 weeks and 6 months, and compare groups. We are interested to find out whether children and parents use the programme, and whether we can collect high quality research data. If we are successful in both of these we plan a larger study to demonstrate the clinical value of SKIP in increasing physical activity, improving psychological health, and improving diabetes management.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: METABOLIC AND ENDOCRINE