Active Breaks in People With Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Interventions
- Behavioral: Active Breaks
- Registration Number
- NCT05706298
- Lead Sponsor
- Liverpool John Moores University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 118
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active breaks 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.
- Primary Outcome Measures
Name Time Method Change in time in target glycaemic range change from baseline to final week of the intervention flash glucose monitoring
- Secondary Outcome Measures
Name Time Method c-peptide baseline c-peptide
Change in insulin dose change from baseline to final week of the intervention Insulin dose
Change in glycaemic variability (coefficient of variation) change from baseline to final week of the intervention flash glucose monitoring
Change in Concentration of Hba1c change from baseline to post intervention (4 weeks) HbA1c
Change in weight change from baseline to post intervention (4 weeks) weight (kg)
Change in BMI change from baseline to post intervention (4 weeks) BMI
Change in waist circumference change from baseline to post intervention (4 weeks) waist circumference (cm)
Change in sedentary behaviour change from baseline to final week of the intervention minutes of sitting
Change in Health-related quality of life change from baseline to post intervention (4 weeks) Short Form-12 Health Survey (SF-12)
Change in Anxiety and depression change from baseline to post intervention (4 weeks) The Hospital Anxiety and Depression Scale (HADS)
Change in carbohydrate intake change from baseline to final week of the intervention carbohydrate intake
Change in Height change from baseline to post intervention (4 weeks) Height (cm)
Change Insulin to CHO ratio change from baseline to post intervention (4 weeks) Insulin to CHO ratio
Change in Diabetes Quality of Life change from baseline to post intervention (4 weeks) Diabetes Quality of Life (DQOL) questionnaire
Change in triglycerides. change from baseline to post intervention (4 weeks) triglycerides.
Change in Insulin Sensitivity Score change from baseline to post intervention (4 weeks) LogeIS
Trial Locations
- Locations (1)
Liverpool John Moores University
🇬🇧Liverpool, United Kingdom