Study protocol: use of a smartphone application to support the implementation of a complex physical activity intervention (+Stay Active) in women with gestational diabetes mellitus-protocol for a non-randomised feasibility study

This is the final version. Available on open access from BMJ Publishing Group via the DOI in this recordINTRODUCTION: Physical activity (PA) interventions have a promising role in the management of gestational diabetes mellitus (GDM). Digital technologies can support PA at scale and remotely. The protocol describes a study designed to determine the feasibility and acceptability of a complex intervention; known as +Stay Active. +Stay Active combines motivational interviewing with a bespoke behaviour change informed smartphone application (Stay-Active) to augment PA levels in women with GDM. METHODS AND ANALYSIS: This is a non-randomised feasibility study using a mixed methods approach. Participants will be recruited from the GDM antenatal clinic at the Women Centre, John Radcliffe Hospital, Oxford. Following baseline assessments (visit 1) including self-reported and device determined PA assessment (wearing a wrist accelerometer), women will be invited to participate in an online motivational interview, then download and use the Stay-Active app (Android or iOS) (visit 2). Women will have access to Stay-Active until 36 weeks gestation, when engagement and PA levels will be reassessed (visit 3). The target sample size is 60 women. Primary outcomes are recruitment and retention rates, compliance and assessment of participant engagement and acceptability with the intervention. Secondary outcomes are assessment of blood glucose control, self-reported and device determined assessment of PA, usage and structured feedback of participant's attitudes to +Stay Active, assessment of health costs and description of maternal and neonatal outcomes. This study will provide key insights into this complex intervention regarding engagement in smartphone technology and the wearing of accelerometers. These data will inform the development of a randomised controlled trial with refinements to intervention implementation. ETHICS AND DISSEMINATION: The study has received a favourable opinion from South Central-Hampshire B Research Ethics Committee; REC reference: 20/SC/0342. Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed journals, conferences and seminar presentations. TRIAL REGISTRATION NUMBER: ISRCTN11366562.Oxford University Hospitals NHS FoundationNational Institute for Health Research (NIHR

Breaking barriers: using the behavior change wheel to develop a tailored intervention to overcome workplace inhibitors to breaking up sitting time

© The Author(s). 2019. Background: The workplace is a prominent domain for excessive sitting. The consequences of increased sitting time include adverse health outcomes such as cardiovascular disease and poor mental wellbeing. There is evidence that breaking up sitting could improve health, however, any such intervention in the workplace would need to be informed by a theoretical evidence-based framework. The aim of this study was to use the Behaviour Change Wheel (BCW) to develop a tailored intervention to break up and reduce workplace sitting in desk-based workers. Methods: The BCW guide was followed for this qualitative, pre-intervention development study. Semi-structured interviews were conducted with 25 office workers (26–59years, mean age 40.9 [SD=10.8] years; 68% female) who were purposively recruited from local council offices and a university in the East of England region. The interview questions were developed using the Theoretical Domains Framework (TDF). Transcripts were deductively analysed using the COM-B (Capability, Opportunity, Motivation – Behaviour) model of behaviour. The Behaviour Change Technique Taxonomy Version 1 (BCTv1) was thereafter used to identify possible strategies that could be used to facilitate change in sitting behaviour of office workers in a future intervention. Results: Qualitative analysis using COM-B identified that participants felt that they had the physical Capability to break up their sitting time, however, some lacked the psychological Capability in relation to the knowledge of both guidelines for sitting time and the consequences of excess sitting. Social and physical Opportunity was identified as important, such as a supportive organisational culture (social) and the need for environmental resources (physical). Motivation was highlighted as a core target for intervention, both reflective Motivation, such as beliefs about capability and intention and automatic in terms of overcoming habit through reinforcement. Seven intervention functions and three policy categories from the BCW were identified as relevant. Finally, 39 behaviour change techniques (BCTs) were identified as potential active components for an intervention to break up sitting time in the workplace. Conclusions: The TDF, COM-B model and BCW can be successfully applied through a systematic process to understand the drivers of behaviour of office workers to develop a co-created intervention that can be used to break up and decrease sitting in the workplace. Intervention designers should consider the identified BCW factors and BCTs when developing interventions to reduce and break up workplace sitting

Stand More AT Work (SMArT Work): using the behaviour change wheel to develop an intervention to reduce sitting time in the workplace

Background: Sitting (sedentary behaviour) is widespread among desk-based office workers and a high level of sedentary behaviour is a risk factor for poor health. Reducing workplace sitting time is therefore an important prevention strategy. Interventions are more likely to be effective if they are theory and evidence-based. The Behaviour Change Wheel (BCW) provides a framework for intervention development. This article describes the development of the Stand More AT Work (SMArT Work) intervention, which aims to reduce sitting time among National Health Service (NHS) office-based workers in Leicester, UK. Methods: We followed the BCW guide and used the Capability, Opportunity and Motivation Behaviour (COM-B) model to conduct focus group discussions with 39 NHS office workers. With these data we used the taxonomy of Behaviour Change Techniques (BCTv1) to identify the most appropriate strategies for facilitating behaviour change in our intervention. To identify the best method for participants to self-monitor their sitting time, a sub-group of participants (n = 31) tested a number of electronic self-monitoring devices. Results: From our BCW steps and the BCT-Taxonomy we identified 10 behaviour change strategies addressing environmental (e.g. provision of height adjustable desks,), organisational (e.g. senior management support, seminar), and individual level (e.g. face-to-face coaching session) barriers. The Darma cushion scored the highest for practicality and acceptability for self-monitoring sitting. Conclusion: The BCW guide, COM-B model and BCT-Taxonomy can be applied successfully in the context of designing a workplace intervention for reducing sitting time through standing and moving more. The intervention was developed in collaboration with office workers (a participatory approach) to ensure relevance for them and their work situation. The effectiveness of this intervention is currently being evaluated in a randomised controlled trial. Trial Registration: ISRCTN10967042 . Registered on 2 February 2015