Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000163808
Ethics application status
Approved
Date submitted
17/12/2020
Date registered
17/02/2021
Date last updated
17/02/2021
Date data sharing statement initially provided
17/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical activity levels in secondary school students with type 1 diabetes
Scientific title
Do Australian adolescents with type 1 diabetes engage in the same amount of moderate-to-vigorous physical activity as their peers and siblings without diabetes, and what are the unique barriers?
Secondary ID [1] 303037 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 320106 0
Condition category
Condition code
Metabolic and Endocrine 318046 318046 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Physical activity will be measured in secondary school students with type 1 diabetes attending the John Hunter Children's Hospital and their eligible siblings without type 1 diabetes. GT3X+ accelerometers will be utilised to measure physical activity and will be worn on the non-dominant wrist of the child continuously over 7 days. The accelerometers will be collected at the end of the 7 days. Dexcom G6 Continuous glucose monitors will be used to collect interstitial glucose levels for the 7 days of the study, with a new sensor inserted on day 1 of the study.
Intervention code [1] 319326 0
Not applicable
Comparator / control treatment
The mean daily MVPA (moderate to vigorous physical activity) of secondary students with type 1 diabetes will be compared to published age-matched data. The data will be derived from results from the Physical Activity 4 Everyone Study (PA4E1) conducted by Hunter New England Population Health during March-June 2012. The main comparison to be made is between participants with type 1 diabetes and the published data from the PA4E1 study. Siblings without diabetes will only be compared to study participants with type 1 diabetes.
Control group
Historical

Outcomes
Primary outcome [1] 326035 0
Mean minutes of MVPA per day will be measured using a GT3X accelerometer worn on the non-dominant wrist of participants for 7-consecutive days.
Timepoint [1] 326035 0
over 7 days
Secondary outcome [1] 389928 0
Percentage time spent in MVPA (adjusted for individual wear time) will be measured using a GT3X accelerometer worn on the non-dominant wrist of participants for 7-consecutive days.
Timepoint [1] 389928 0
over 7 days
Secondary outcome [2] 389929 0
Mean minutes of total, vigorous, moderate and sedentary activity per day will be measured using a GT3X accelerometer worn on the non-dominant wrist of participants for 7-consecutive days.
Timepoint [2] 389929 0
over 7 days
Secondary outcome [3] 389930 0
Percentage wear time in total, vigorous, moderate and sedentary activity will be measured using a GT3X accelerometer worn on the non-dominant wrist of participants for 7-consecutive days.
Timepoint [3] 389930 0
over 7 days
Secondary outcome [4] 389931 0
Barriers to physical activity scores will be generated using the Barriers to Physical Activity in Type 1 Diabetes (BAPAD1) questionnaire
Timepoint [4] 389931 0
visit 1 - one off
Secondary outcome [5] 389932 0
Fear of hypoglycaemia will be measured using the Hypoglycaemic Fear Survey Worry Subscale in children with T1D (HFS-C)
Timepoint [5] 389932 0
visit 1 - one off
Secondary outcome [6] 389933 0
Percentage of time in target glycaemia range (BGL 3.9 to 10.0 mmol/L) will be measured using Dexcom G6 continuous glucose monitors worn for 7-consecutive days.
Timepoint [6] 389933 0
over 7 days
Secondary outcome [7] 390726 0
Fear of hypoglycaemia will be measured using the Hypoglycaemic Fear Survey Worry Subscale in parents of children with T1D (HFS-P)
Timepoint [7] 390726 0
visit 1 - one off

Eligibility
Key inclusion criteria
Inclusion Criteria for participants with T1D
• aged 12.0-17.9 years
• diagnosed with T1D for > 6 months
• attend secondary school
Inclusion Criteria for siblings of participants with T1D
• aged 12.0-17.9 years
• do not have diabetes
• attend secondary school
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Coexisting medical problems preventing participation in physical activity

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/02/2021
Actual
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18233 0
John Hunter Children's Hospital - New Lambton
Recruitment postcode(s) [1] 32297 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 307450 0
University
Name [1] 307450 0
University of Newcastle
Country [1] 307450 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr,
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 308123 0
Other Collaborative groups
Name [1] 308123 0
Hunter Medical Research Institute
Address [1] 308123 0
Lot 1, Kookaburra Cct,
New Lambton Heights NSW 2305
Country [1] 308123 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307528 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 307528 0
Lot 1, Kookaburra Circuit,
New Lambton Heights NSW 2305
Ethics committee country [1] 307528 0
Australia
Date submitted for ethics approval [1] 307528 0
Approval date [1] 307528 0
01/12/2020
Ethics approval number [1] 307528 0
2020/ETH02279

Summary
Brief summary
The study will take place over 7 days in a free-living environment. It will involve secondary school students between the ages of 12 and 17.9 years who have had type 1 diabetes for greater than 6 months and their siblings (when available) aged 12 and 17.9 years who do not have diabetes. During this 7-day period, physical activity levels will be monitored continuously using GT3X+ accelerometers and interstitial blood glucose levels will be monitored through the use of a continuous glucose monitor. At study visit 1, the participants with type 1 diabetes and one parent or guardian will be asked to complete a fear of hypoglycaemia survey each. Participants with type 1 diabetes will also complete a barriers to physical activity survey. At the end of the study period physical activity outcomes will be compared to published data from an age-matched population. This will help us gather information on physical activity levels in secondary school children with type 1 diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107554 0
Dr Carmel Smart
Address 107554 0
Department of Endocrinology and Diabetes
John Hunter Children's Hospital
Lookout Road,
Newcastle, NSW 2305
Country 107554 0
Australia
Phone 107554 0
+61401624294
Fax 107554 0
Email 107554 0
[email protected]
Contact person for public queries
Name 107555 0
Dr Carmel Smart
Address 107555 0
Department of Endocrinology and Diabetes
John Hunter Children's Hospital
Lookout Road,
Newcastle, NSW 2305
Country 107555 0
Australia
Phone 107555 0
+61401624294
Fax 107555 0
Email 107555 0
[email protected]
Contact person for scientific queries
Name 107556 0
Dr Carmel Smart
Address 107556 0
Department of Endocrinology and Diabetes
John Hunter Children's Hospital
Lookout Road,
Newcastle, NSW 2305
Country 107556 0
Australia
Phone 107556 0
+61401624294
Fax 107556 0
Email 107556 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.