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

Abstract

BackgroundRegular 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.MethodsUp 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).DiscussionThe 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.Trial registrationISRCTN, ISRCTN48994721. Registered on 28 October 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1719-0) contains supplementary material, which is available to authorized users.

The role of theories in interventions targeting preteens with Type 1 diabetes: A critical literature review

“…Self‐efficacy can be developed through mastery experiences (developing knowledge and skills to perform behaviour), vicarious experiences (observing others' actions), social persuasion (strengthening beliefs about capabilities), and somatic/emotional states (judging capabilities) (Bandura, ). Five studies (Ambrosino et al, ; Blake et al, ; Grey et al, ; Nansel et al, ; Nansel, Iannotti, & Liu, ) cite publications by Bandura, and one study (Streisand & Mednick, ) does not.…”

“…In the studies, self‐efficacy is linked to individual control as expressed by the ability to determine and manage achievable tasks in diabetes care, such as measuring blood glucose levels and being physically active and attentive to food intake. Two studies (Blake et al, ; Toscos, ) describe the concept of self‐efficacy in relation to the development of specific intervention components, such as use of an activity diary and blood glucose monitoring technology. This includes addressing behaviour and diabetes management using small steps.…”

“…Another central concept applied in the studies is mastery learning or behavioural capacity, which is described as the goal of skills training (Grey et al, ) and a mechanism to develop self‐efficacy (Blake et al, ; Nansel et al, ). In the studies, mastery learning is often linked to observational learning and activity monitoring.…”

“…In the studies, mastery learning is often linked to observational learning and activity monitoring. It includes skills training through, for example, learning a street dance routine (Blake et al, ) and use of personal trainers (Nansel et al, ). However, it is unclear how learning a street dance routine and use of personal trainers can facilitate self‐efficacy.…”

“…Bandura () does not specifically refer to reinforcement, but it is closely related to his concepts of incentive and vicarious motivators for behaviour. In the studies, reinforcement is operationalized in terms of role models (vicarious experience) (Blake et al, ), assessing progress and revising plans (mastery experience) (Nansel et al, ; Nansel, Iannotti, & Liu, ), as well as positive feedback to participants for their accomplishments (verbal persuasion) (Nansel et al, ; Streisand & Mednick, ; Toscos, ). Mastery learning and reinforcement are not linked to specific outcome measures in the studies.…”