Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000443796
Ethics application status
Approved
Date submitted
12/04/2013
Date registered
18/04/2013
Date last updated
11/03/2020
Date data sharing statement initially provided
11/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Activity levels in children and adolescents with type 1 diabetes
Scientific title
Evaluation of physical activity and sedentary behaviour in youth with type 1 diabetes using the Multimedia Activity
Recall for Children and Adolescents (MARCA)
Secondary ID [1] 282317 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 288860 0
Condition category
Condition code
Metabolic and Endocrine 289203 289203 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Actvitiy is observed using an accelerometer that is worn for 7 days after recruitment
Intervention code [1] 286932 0
Not applicable
Comparator / control treatment
Healthy children had assesments of activity using MARCA and accelerometers over the last 10 years.
Children come from the community please refer to these references
Ridley K. Olds T, Hill A. The Multimedia Activity Recall for Children and Adolescents (MARCA): development and evaluation. International Journal of Behavioural Nutrition and Physical Activity, 2006,3:10.
Olds TS, Ridley K, Dollman J, Maher CA. The validity of a computerized use of time recall, the multimedia activity recall for children and adolescents. Pediatr Exerc Sci. 2010 Feb;22(1):34-43.
Foley LS, Maddison R, Rush E, Olds TS, Ridley K, Jiang Y. Doubly labeled water validation of a computerized use-of-time recall in active young people. Metabolism. 2013 Jan;62(1):163-9. doi: 10.1016/j.metabol.2012.07.021. Epub 2012 Sep 11.
Control group
Historical

Outcomes
Primary outcome [1] 289315 0
Evaluation of physical activity and sedentary behaviour in children and adolescents with type 1 diabetes using 2 Multimedia activity recall for children and adolescents (MARCA) and accelerometer
Timepoint [1] 289315 0
MARCA questionnaire will be done twice (Baseline and 7 days later)
Accelerometer will be worn for 7 days
Secondary outcome [1] 302229 0
Evaluation of the association between physical activity and markers of diabetes control measured by HbA1c
Timepoint [1] 302229 0
Only one

Eligibility
Key inclusion criteria
Children with type 1 diabetes
Minimum age
9 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with other types of diabetes i.e. type 2 diabetes
Children with intellectual or mental impairment
Children who don't speak English

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
24/04/2013
Actual
26/04/2013
Date of last participant enrolment
Anticipated
17/04/2014
Actual
19/01/2019
Date of last data collection
Anticipated
18/12/2020
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 872 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 6683 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 287077 0
Self funded/Unfunded
Name [1] 287077 0
This project has not received any funding
Country [1] 287077 0
Primary sponsor type
Individual
Name
Dr Alexia Pena
Address
Women's and Children's Hospital
72 King William Road, North Adelaide, SA 5006
Country
Australia
Secondary sponsor category [1] 285852 0
None
Name [1] 285852 0
Address [1] 285852 0
Country [1] 285852 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289092 0
WCHN Human Research Ethics Committee
Ethics committee address [1] 289092 0
Ethics committee country [1] 289092 0
Australia
Date submitted for ethics approval [1] 289092 0
Approval date [1] 289092 0
20/03/2013
Ethics approval number [1] 289092 0
HREC/13/WCHN/35

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39210 0
Dr Alexia S Pena
Address 39210 0
The University of Adelaide and Women's and Children's Hospital
72 King William Road, North Adelaide, SA, 5006
Country 39210 0
Australia
Phone 39210 0
+61881618134
Fax 39210 0
+61881617031
Email 39210 0
[email protected]
Contact person for public queries
Name 39211 0
Alexia S Pena
Address 39211 0
The University of Adelaide and Women's and Children's Hospital
72 King William Road, North Adelaide, SA, 5006
Country 39211 0
Australia
Phone 39211 0
+61881618134
Fax 39211 0
+61881617031
Email 39211 0
[email protected]
Contact person for scientific queries
Name 39212 0
Alexia S Pena
Address 39212 0
The University of Adelaide and Women's and Children's Hospital
72 King William Road, North Adelaide, SA, 5006
Country 39212 0
Australia
Phone 39212 0
+61881618134
Fax 39212 0
+61881617031
Email 39212 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.