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Can 4 weeks of real-world active breaks improve glycaemic management in sedentary adults with type 1 diabetes? The EXTOD-Active randomised control trial protocol

Jenkins, JG, Cocks, M, Narendran, P, Andrews, RC, Shields, BM, Scott, SN, Lucas, SJE, Rendeiro, C and Hesketh, K (2025) Can 4 weeks of real-world active breaks improve glycaemic management in sedentary adults with type 1 diabetes? The EXTOD-Active randomised control trial protocol. BMJ Open Sport and Exercise Medicine, 11 (2).

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Abstract

Sedentary behaviour is associated with an increased risk of cardiovascular disease and all-cause mortality in individuals with type 1 diabetes (T1D). Recent laboratory-based research suggests that breaking up prolonged sedentary periods improves glycaemic markers in people with T1D. However, the effects of breaking up sedentary behaviour for prolonged periods in real-world settings remain unknown. This study aims to assess the effect of 4 weeks of active breaks on time spent within the target glycaemic range (time in range (TIR), 3.9-10.0 mmol/L) in adults with T1D Adults with T1D (n=118) who are sedentary for ≥8 hours per day will first complete a 7-day baseline assessment. Participants will then be randomised into either a control group (maintenance of habitual lifestyle) or an intervention group, where active breaks (3 min of self-paced walking every 30 min between 09:00 and 17:00, Monday through Friday) will be prescribed for 4 weeks. Activity levels (activPAL), TIR (via continuous glucose monitor), insulin dose and carbohydrate intake will be monitored throughout. The effect of active breaks on TIR will be compared between baseline and week 4, with data analysed using analysis of covariance (ANCOVA). The trial has been approved in the UK by the West Midlands-Solihull Ethics Committee (22/WM/0221). The findings from the study will be disseminated through peer-reviewed journals and presentations at national and international scientific conferences. Trial registration number NCT05706298.

Item Type: Article
Uncontrolled Keywords: 4206 Public Health; 32 Biomedical and Clinical Sciences; 3202 Clinical Sciences; 42 Health Sciences; Clinical Research; Prevention; Clinical Trials and Supportive Activities; Cardiovascular; Autoimmune Disease; Diabetes; 3.1 Primary prevention interventions to modify behaviours or promote wellbeing; Metabolic and endocrine; 3 Good Health and Well Being; 1106 Human Movement and Sports Sciences; 3202 Clinical sciences; 4207 Sports science and exercise
Subjects: R Medicine > RC Internal medicine > RC1200 Sports Medicine
Divisions: Sport and Exercise Sciences
Publisher: BMJ
SWORD Depositor: A Symplectic
Date Deposited: 28 Apr 2025 10:54
Last Modified: 28 Apr 2025 11:00
DOI or ID number: 10.1136/bmjsem-2025-002594
URI: https://researchonline.ljmu.ac.uk/id/eprint/26277
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