Active Breaks in People With Type 1 Diabetes (EXTOD-Active)

Liverpool John Moores University

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Behavioral: Active Breaks

Study type: Interventional

Funder types: Other

Identifiers

NCT05706298

22LJMUSPONSOR010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 estimated patients

Sex: All

Ages: 18 to 66 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Habitual lifestyle

No Intervention group

Description:

Participants in the control group will be asked to maintain their habitual lifestyle.

Active breaks

Experimental group

Description:

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.

Treatment:

Behavioral: Active Breaks