Daniel P Bailey1,2, Charlotte L Edwardson3,4, Yannis Pappas5, Feng Dong6, David J Hewson5, Stuart J H Biddle7, Marsha L Brierley8,9, Angel M Chater10. 1. Sedentary Behaviour, Health and Disease Research Group, Brunel University London, Kingston Lane, Uxbridge, UB8 3PH, UK. daniel.bailey@brunel.ac.uk. 2. Division of Sport, Health and Exercise Sciences, Department of Life Sciences, Brunel University London, Kingston Lane, Uxbridge, UB8 3PH, UK. daniel.bailey@brunel.ac.uk. 3. Leicester Lifestyle and Health Research Group, Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. 4. NIHR Leicester Biomedical Research Centre, Leicester General Hospital, Leicester, LE5 4PW, UK. 5. Institute for Health Research, University of Bedfordshire, Luton, LU1 3JU, UK. 6. Department of Computer and Information Sciences, University of Strathclyde, G1 1XH, Glasgow, UK. 7. Centre for Health Research, University of Southern Queensland, Springfield, QLD, 4300, Australia. 8. Sedentary Behaviour, Health and Disease Research Group, Brunel University London, Kingston Lane, Uxbridge, UB8 3PH, UK. 9. Division of Sport, Health and Exercise Sciences, Department of Life Sciences, Brunel University London, Kingston Lane, Uxbridge, UB8 3PH, UK. 10. Institute for Sport and Physical Activity Research, Centre for Health, Wellbeing and Behaviour Change, University of Bedfordshire, Polhill Avenue, Bedford, MK41 9EA, UK.
Abstract
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.
RCT Entities:
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.
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