NCT05706298

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1.7 years

First QC Date

December 21, 2022

Last Update Submit

October 9, 2023

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in time in target glycaemic range

    flash glucose monitoring

    change from baseline to final week of the intervention

Secondary Outcomes (16)

  • Change in glycaemic variability (coefficient of variation)

    change from baseline to final week of the intervention

  • Change in insulin dose

    change from baseline to final week of the intervention

  • Change in Concentration of Hba1c

    change from baseline to post intervention (4 weeks)

  • Change Insulin to CHO ratio

    change from baseline to post intervention (4 weeks)

  • Change in Anxiety and depression

    change from baseline to post intervention (4 weeks)

  • +11 more secondary outcomes

Study Arms (2)

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.

Behavioral: Active Breaks

Interventions

Active BreaksBEHAVIORAL

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

Active breaks

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool John Moores University

Liverpool, L33AF, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40195972DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 31, 2023

Study Start

December 7, 2022

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)