The Effect of Interrupting Sitting With Regular Active Breaks on Glycaemia and Daily Insulin Dose in Sedentary People With Type 1 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Change in time in target glycaemic range
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 66 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •T1D diagnosis more than 3 years ago
- •Sedentary (> 10h per waking day sedentary (sitting or lying)
- •Using insulin therapy with multiple daily injections or insulin pump
- •Aged 18-66 (UK retirement age)
- •Use of Abbot FreeStyle Libre 2 fGM (>6 weeks to avoid potential lifestyle changes as a result of sensor use)
Exclusion Criteria
- •Engaged in structured planned exercise (e.g. running, cycling, gym, or sports)
- •Pregnancy or planning to become pregnant
- •<6 months postpartum or stopped breastfeeding <1 month before recruitment
- •Existing cerebrovascular or cardiovascular disease
- •Significant history of hyperglycaemia (HbA1c >85 mmol/mol)
- •History of severe hypoglycaemia requiring third party assistance within the last 3 months
Arms & Interventions
Habitual lifestyle
Participants in the control group will be asked to maintain their habitual lifestyle.
Active breaks
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.
Intervention: Active Breaks (Behavioral)
Outcomes
Primary Outcomes
Change in time in target glycaemic range
Time Frame: change from baseline to final week of the intervention
flash glucose monitoring
Secondary Outcomes
- Change in Concentration of Hba1c(change from baseline to post intervention (4 weeks))
- Change in sedentary behaviour(change from baseline to final week of the intervention)
- Change in insulin dose(change from baseline to final week of the intervention)
- Change in glycaemic variability (coefficient of variation)(change from baseline to final week of the intervention)
- Change in weight(change from baseline to post intervention (4 weeks))
- Change in BMI(change from baseline to post intervention (4 weeks))
- Change in waist circumference(change from baseline to post intervention (4 weeks))
- Change in Health-related quality of life(change from baseline to post intervention (4 weeks))
- Change in Anxiety and depression(change from baseline to post intervention (4 weeks))
- c-peptide(baseline)
- Change in carbohydrate intake(change from baseline to final week of the intervention)
- Change in Height(change from baseline to post intervention (4 weeks))
- Change Insulin to CHO ratio(change from baseline to post intervention (4 weeks))
- Change in Diabetes Quality of Life(change from baseline to post intervention (4 weeks))
- Change in triglycerides.(change from baseline to post intervention (4 weeks))
- Change in Insulin Sensitivity Score(change from baseline to post intervention (4 weeks))