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the investigators aim to determine the effect of 4 weeks of frequent active breaks from prolonged sitting on time in target glycaemic range in people with type 1 diabetes with high habitual sedentary behaviour.
An open-label randomised controlled trial, whereby participants will complete pre-randomisation baseline procedures before allocation to 4wks of habitual activity (control) or active breaks. Interstitial glucose concentrations (fGM), insulin dose and physical activity/ postural transitions (ActivPAL) will be monitored throughout. To improve generalisability and feasibility of recruiting the required number of participants, the study will be completed in a free-living environment using remote data collection methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Habitual lifestyle | No Intervention | Participants in the control group will be asked to maintain their habitual lifestyle. | |
| Active breaks | Experimental | Participants will be asked to interrupt sitting with 3 min bouts of walking every 30 min (16 bouts per day, equalling 48 min of walking) from 9am-5pm every day throughout the 4 week period. To improve adherence should participants miss a bout of walking they will be asked to do 6 min during the next bout. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Breaks | Behavioral | Participants will be asked to interrupt sitting with 3 min bouts of walking every 30 min from 9am-5pm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in time in target glycaemic range | flash glucose monitoring | change from baseline to final week of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycaemic variability (coefficient of variation) | flash glucose monitoring | change from baseline to final week of the intervention |
| Change in insulin dose | Insulin dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool John Moores University | Recruiting | Liverpool | L33AF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40195972 | Derived | Jenkins JG, Cocks M, Narendran P, Andrews RC, Shields BM, Scott SN, Lucas SJE, Rendeiro C, Hesketh K. 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 Exerc Med. 2025 Apr 5;11(2):e002594. doi: 10.1136/bmjsem-2025-002594. eCollection 2025. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Randomised controlled trial
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| change from baseline to final week of the intervention |
| Change in Concentration of Hba1c | HbA1c | change from baseline to post intervention (4 weeks) |
| Change Insulin to CHO ratio | Insulin to CHO ratio | change from baseline to post intervention (4 weeks) |
| Change in Anxiety and depression | The Hospital Anxiety and Depression Scale (HADS) | change from baseline to post intervention (4 weeks) |
| Change in Diabetes Quality of Life | Diabetes Quality of Life (DQOL) questionnaire | change from baseline to post intervention (4 weeks) |
| Change in Health-related quality of life | Short Form-12 Health Survey (SF-12) | change from baseline to post intervention (4 weeks) |
| Change in Height | Height (cm) | change from baseline to post intervention (4 weeks) |
| Change in weight | weight (kg) | change from baseline to post intervention (4 weeks) |
| Change in BMI | BMI | change from baseline to post intervention (4 weeks) |
| Change in waist circumference | waist circumference (cm) | change from baseline to post intervention (4 weeks) |
| Change in triglycerides. | triglycerides. | change from baseline to post intervention (4 weeks) |
| Change in Insulin Sensitivity Score | LogeIS | change from baseline to post intervention (4 weeks) |
| c-peptide | c-peptide | baseline |
| Change in sedentary behaviour | minutes of sitting | change from baseline to final week of the intervention |
| Change in carbohydrate intake | carbohydrate intake | change from baseline to final week of the intervention |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |