BACKGROUND: People with type 2 diabetes mellitus (T2DM) generally spend a large amount of time sitting . This increases their risk of cardiovascular disease, premature mortality, diabetes-related complications and mental health problems . There is a paucity of research that has evaluated interventions aimed at reducing and breaking up sitting in people with T2DM . The primary aim of this study is to assess the feasibility of delivering and evaluating a tailored intervention to reduce and break up sitting in ambulatory adults with T2DM.
METHODS: This is a mixed-methods randomised controlled feasibility trial . Participants (n=70) with T2DM aged 18-85 years who sit ≥7 h/day and are able to ambulate independently will be randomly allocated to receive the REgulate your SItting Time (RESIT) intervention or usual care (control group) for 24 weeks . RESIT is a person-focused intervention that delivers a standardised set of behaviour change techniques to the participants, but the mode through which they are delivered can vary depending on the tools selected by each participant . The intervention includes an online education programme, health coach support, and a range of self-selected tools (smartphone apps, computer-prompt software, and wearable devices) that deliver behaviour change techniques such as self-monitoring of sitting and providing prompts to break up sitting . Measures will be taken at baseline , 12 and 24 weeks . Eligibility, recruitment, retention and data completion rates will be used to assess trial feasibility . Sitting, standing and stepping will be measured using a thigh-worn activity monitor . Cardiometabolic health, physical function, psychological well-being, sleep and musculoskeletal symptoms will also be assessed . A process evaluation will be conducted including evaluation of intervention acceptability and fidelity .
DISCUSSION: This study will identify the feasibility of delivering a tailored intervention to reduce and break up sitting in ambulatory adults with T2DM and evaluating it through a randomised controlled trial (RCT) design . The findings will inform a fully powered RCT to evaluate the effectiveness of the intervention .
TRIAL REGISTRATION: ISRCTN, ISRCTN14832389; Registered 6 August 2020.
Index: Behaviour change, Diabetes, Physical activity, Prolonged sitting, Sedentary behaviour, activPAL