Active Breaks in People With Type 1 Diabetes

NCT ID: NCT05706298

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-07

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Habitual lifestyle

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Active Breaks

Intervention Type BEHAVIORAL

Participants will be asked to interrupt sitting with 3 min bouts of walking every 30 min from 9am-5pm

Interventions

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Active Breaks

Participants will be asked to interrupt sitting with 3 min bouts of walking every 30 min from 9am-5pm

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liverpool John Moores University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Liverpool John Moores University

Liverpool, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Matthew Cocks, PhD

Role: primary

07540191292

References

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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.

Reference Type DERIVED
PMID: 40195972 (View on PubMed)

Other Identifiers

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22LJMUSPONSOR010

Identifier Type: -

Identifier Source: org_study_id

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