Active Breaks in People With Type 1 Diabetes - Clinical Trial for Type 1 Diabetes | NCT05706298

Back to results

Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Active Breaks

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Liverpool John Moores UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Habitual lifestyle

Active breaks

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in time in target glycaemic range

flash glucose monitoring

Secondary Outcome Measures

Change in glycaemic variability (coefficient of variation)

flash glucose monitoring

Change in insulin dose

Insulin dose

Change in Concentration of Hba1c

HbA1c

Change Insulin to CHO ratio

Insulin to CHO ratio

Change in Anxiety and depression

The Hospital Anxiety and Depression Scale (HADS)

Change in Diabetes Quality of Life

Diabetes Quality of Life (DQOL) questionnaire

Change in Health-related quality of life

Short Form-12 Health Survey (SF-12)

Change in Height

Height (cm)

Change in weight

weight (kg)

Change in BMI

BMI

Change in waist circumference

waist circumference (cm)

Change in triglycerides.

triglycerides.

Change in Insulin Sensitivity Score

LogeIS

c-peptide

Change in sedentary behaviour

minutes of sitting

Change in carbohydrate intake

carbohydrate intake

Full Information

NCT ID

NCT05706298

First Posted

December 21, 2022

Last Updated

October 9, 2023

Sponsor

Liverpool John Moores University

1. Study Identification

Unique Protocol Identification Number

NCT05706298

Brief Title

Active Breaks in People With Type 1 Diabetes

Acronym

EXTOD-Active

Official Title

The Effect of Interrupting Sitting With Regular Active Breaks on Glycaemia and Daily Insulin Dose in Sedentary People With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 7, 2022 (Actual)

Primary Completion Date

August 1, 2024 (Anticipated)

Study Completion Date

August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Liverpool John Moores University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomised controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Habitual lifestyle

Arm Type

No Intervention

Arm Description

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

Arm Title

Active breaks

Arm Type

Experimental

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

Active Breaks

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in time in target glycaemic range

Description

flash glucose monitoring

Time Frame

change from baseline to final week of the intervention

Secondary Outcome Measure Information:

Title

Change in glycaemic variability (coefficient of variation)

Description

flash glucose monitoring

Time Frame

change from baseline to final week of the intervention

Title

Change in insulin dose

Description

Insulin dose

Time Frame

change from baseline to final week of the intervention

Title

Change in Concentration of Hba1c

Description

HbA1c

Time Frame