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

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ClinicalTrials.gov Identifier: NCT05706298
Recruitment Status : Recruiting
First Posted : January 31, 2023
Last Update Posted : January 31, 2023
Sponsor:
Information provided by (Responsible Party):
Liverpool John Moores University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: Active Breaks Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Interrupting Sitting With Regular Active Breaks on Glycaemia and Daily Insulin Dose in Sedentary People With Type 1 Diabetes
Actual Study Start Date : December 7, 2022
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Habitual lifestyle
Participants in the control group will be asked to maintain their habitual lifestyle.
Experimental: 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.
 Behavioral: Active Breaks
Participants will be asked to interrupt sitting with 3 min bouts of walking every 30 min from 9am-5pm


Outcome Measures
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Primary Outcome Measures :
  1. Change in time in target glycaemic range [ Time Frame: change from baseline to final week of the intervention ]
    flash glucose monitoring


Secondary Outcome Measures :
  1. Change in glycaemic variability (coefficient of variation) [ Time Frame: change from baseline to final week of the intervention ]
    flash glucose monitoring

  2. Change in insulin dose [ Time Frame: change from baseline to final week of the intervention ]
    Insulin dose

  3. Change in Concentration of Hba1c [ Time Frame: change from baseline to post intervention (4 weeks) ]
    HbA1c

  4. Change Insulin to CHO ratio [ Time Frame: change from baseline to post intervention (4 weeks) ]
    Insulin to CHO ratio

  5. Change in Anxiety and depression [ Time Frame: change from baseline to post intervention (4 weeks) ]
    The Hospital Anxiety and Depression Scale (HADS)

  6. Change in Diabetes Quality of Life [ Time Frame: change from baseline to post intervention (4 weeks) ]
    Diabetes Quality of Life (DQOL) questionnaire

  7. Change in Health-related quality of life [ Time Frame: change from baseline to post intervention (4 weeks) ]
    Short Form-12 Health Survey (SF-12)

  8. Change in Height [ Time Frame: change from baseline to post intervention (4 weeks) ]
    Height (cm)

  9. Change in weight [ Time Frame: change from baseline to post intervention (4 weeks) ]
    weight (kg)

  10. Change in BMI [ Time Frame: change from baseline to post intervention (4 weeks) ]
    BMI

  11. Change in waist circumference [ Time Frame: change from baseline to post intervention (4 weeks) ]
    waist circumference (cm)

  12. Change in triglycerides. [ Time Frame: change from baseline to post intervention (4 weeks) ]
    triglycerides.

  13. Change in Insulin Sensitivity Score [ Time Frame: change from baseline to post intervention (4 weeks) ]
    LogeIS

  14. c-peptide [ Time Frame: baseline ]
    c-peptide

  15. Change in sedentary behaviour [ Time Frame: change from baseline to final week of the intervention ]
    minutes of sitting

  16. Change in carbohydrate intake [ Time Frame: change from baseline to final week of the intervention ]
    carbohydrate intake


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05706298


Locations
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United Kingdom
Liverpool John Moores University Recruiting
Liverpool, United Kingdom, L33AF
Contact: Matthew Cocks, PhD    07540191292    m.s.cocks@ljmu.ac.uk   
Sponsors and Collaborators
Liverpool John Moores University
More Information
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Responsible Party: Liverpool John Moores University
ClinicalTrials.gov Identifier: NCT05706298    
Other Study ID Numbers: 22LJMUSPONSOR010
First Posted: January 31, 2023    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases