Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000061730
Ethics application status
Approved
Date submitted
2/12/2021
Date registered
20/01/2022
Date last updated
22/12/2022
Date data sharing statement initially provided
20/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of physical activity assessment questionnaires for youth with Type 1 Diabetes
Scientific title
Validation of physical activity assessment questionnaires for youth with Type 1 Diabetes
Secondary ID [1] 305687 0
RGS0000004866
Universal Trial Number (UTN)
U1111-1270-9653
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 324164 0
Condition category
Condition code
Metabolic and Endocrine 321637 321637 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study, involving eligible patients attending the diabetes service’s outpatient clinics. The physical activity (PA) levels of the patients will be evaluated subjectively using three PA questionnaires, and compared against objective measurements of PA using the Actigraph GT3x (7, 8, 9)- a research grade triaxial accelerometer measured over the previous 7 days.

We will test the validity of three tools in this project:
1) Physical Activity Questionnaire for Older Children (PAQ-C)/Physical Activity Questionnaire for Adolescents (PAQ-A).
2) The Previous Day Physical Activity Recall (PDPAR)
3) The single item tool adapted from Procheska et al

PA will be measured objectively using a triaxial accelerometer using the Actigraph GT3x- a research grade triaxial accelerometer (https://www.actigraphcorp.com/support/activity-monitors/gt3x/) used in many trials to measure duration and intensity of PA in both youth and adults. In addition, as a secondary aspect of the study, we will explore the associations between components of PA and contemporaneous glucose control through the collection of continuous glucose monitoring (CGM) data in those youth wearing CGM devices during the period corresponding to actigraphy wear time.

Participants will be required to wear the Actigraph GT3x (triaxial accelerometer) which will be secured on the hip via an elastic band for a period of 7-days. Data from the Actigraph GT3x will be recorded on a continuous basis in epoch lengths of 0.25 minutes. At the end of the 7-day wearing period, participants will complete all three PA questionnaires in a randomised order. Participants should be able to complete all three PA questionnaires in 30-minutes.

CGM data will only be collected from pre-exisitng CGM device users who consent to their data being used as a secondary analysis for this project. Participants who are not currently using CGM devices will continue with the study as per usual and no CGM devices will be provided. CGM data will be recorded over the 7-day period in 5-minute intervals to determine measurements of glycaemic variability (percentage time-in-range; %TIR and coefficient of variation; CV).
Intervention code [1] 322081 0
Not applicable
Comparator / control treatment
Triaxial accelermoeter data (Actigraph GT3x)
Control group
Active

Outcomes
Primary outcome [1] 329403 0
To establish the validity coefficient the Physical Activity Questionnaire for Older Children (PAQ-C)/Physical Activity Questionnaire for Adolescents (PAQ-A) for use against Actigraph GT3x (a research grade triaxial accelerometer) data that will be measured over a 7-day period. The PAQ-C, developed by The University of British Columbia and University of Saskatchewan in Canada has been validated in 2 independent samples (a total of 186 youth aged 8-13) and shown to be moderately related to objectively measured activity and fitness with no gender differences. It is a 7 day recall instrument, contains 9 items, and produces a composite score as a measure of overall PA level. The PAQ-A is similar, but removes a morning recess question not applicable to older youth.
Timepoint [1] 329403 0
The PAQ-C/PAQ-A will be completed at the end of the 7-day period of wearing the Actigraph GT3x, Actigraph GT3x will be recording continuously over the 7-day period at an epoch length of 0.25min.
Primary outcome [2] 329404 0
To establish the validity coefficient of the Previous Day Physical Activity Recall (PDPAR) questionnaire for use against Actigraph GT3x (a research grade triaxial accelerometer) data which is considered the gold standard for evaluating phyiscal activity levels. The PDPAR is a self-report instrument intended to capture the previous day's physical activity of children, specifically after school hours. It uses a time-based recall approach by asking the child to recall and record their physical activity from the previous day between 3:00pm and 11:30pm.
Timepoint [2] 329404 0
The PDPAR will be completed at the end of the 7-day period of wearing the Actigraph GT3x, Actigraph GT3x will be recording continuously over the 7-day period at an epoch length of 0.25min.
Primary outcome [3] 329968 0
To establish the validity coefficient of the single item tool adapted from Procheska et al. for use against Actigraph GT3x (a research grade triaxial accelerometer) data which is considered the gold standard for evaluating phyiscal activity levels. The single item tool asks: “Over the past 7 days, on how many days were you/your child engaged in moderate to vigorous physical activity (activity that increases heart rate and gets you/your child out of breath some of the time) for at least 60 minutes? Physical activity can be accumulated over the entire day (e.g., for example in bouts of 10 minutes)?”
Timepoint [3] 329968 0
The single item tool will be completed at the end of the 7-day period of wearing the Actigraph GT3x, Actigraph GT3x will be recording continuously over the 7-day period at an epoch length of 0.25min.
Secondary outcome [1] 402467 0
To measure moderate intensity physical activity (PA) by three dimensional accelerometry in youth with T1D.
Timepoint [1] 402467 0
During the 7-day period that participants are required to wear the Actigraph GT3x. Actigraph GT3x will be recording continuously over at an epoch length of 0.25min.
Secondary outcome [2] 403748 0
To determine individual glycaemic variability (percentage time-in-range; %TIR), as determined by a continuous glucose monitoring (CGM) system
Timepoint [2] 403748 0
%TIR (a measure of glycaemic variability) will be determined by CGM readings that will be recorded in 5-min intervals over a 7-day period.
Secondary outcome [3] 404476 0
To measure vigorous intensity physical activity (PA) by three dimensional accelerometry in youth with T1D.
Timepoint [3] 404476 0
During the 7-day period that participants are required to wear the Actigraph GT3x. Actigraph GT3x will be recording continuously over at an epoch length of 0.25min.
Secondary outcome [4] 404477 0
To determine individual glycaemic variability (coefficient of variation; CV), as determined by a continuous glucose monitoring (CGM) system.
Timepoint [4] 404477 0
CV (a measure of glycaemic variability) will be determined by CGM readings that will be recorded in 5-min intervals over a 7-day period.

Eligibility
Key inclusion criteria
Children and adolescents with type 1 diabetes meeting 2 or more of the following criteria:
1. documented positive islet autoantibodies to T1D
2. C-peptide <0.05 nmol/L
3. permanent insulin requirement
Minimum age
8 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. English not primary language
2. Comorbidities that substantially impact ability to perform exercise.
3. Individuals with reduced cognitive capacity who do not have capacity to adhere to the study protocol

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Total scores and subscale scores (where appropriate) will be calculated for self-report PA measures and based on the instructions provided by scale authors. Confirmatory factor analyses using polychoric correlation matrices will be conducted for the multi-item scales and Cronbach’s alpha will be calculated to provide an indication of internal consistency reliability. Accelerometry data will be used to calculate MVPA (daily minutes of moderate physical activity; MVPA min/day) and VPA (minutes of vigorous physical activity; VPA min/day) as above.

The Actigraph device will be downloaded and data analysed using ActiLife software. Mean daily values for the sum of the vertical axis acceleration counts will be used as a measure of total activity, and counts per minute as a measure of intensity. Evenson cut-points will be used to estimate daily minutes of moderate-to-vigorous physical activity (MVPA; =2296 CPM; includes vigorous) and vigorous physical activity (=4012 CPM).
Continuous glucose monitoring data will be downloaded from standard clinical reporting platforms (eg. Dexcom Clarity, Medtronic CareLink) to analyse percent time in range (%TIR), defined as glucose level of 3.9-10 mmol/L and glucose variability as measured by the CV; both standard clinical reporting metrics for CGM data in youth with T1D as per international consensus (ADA 2019 CGM consensus).Measures of central tendency (mean (SD), median (IQR) as appropriate) will be presented for physical activity measures (self-report and accelerometer) and glucose outcomes.

The degree of agreement between each self-report tool and (MVPA + VPA) will be assessed by determining the validity coefficient along with its 95% confidence interval. The validity coefficient will be determined using the Pearson product-moment correlation where the relevant assumptions are met; otherwise, the Spearman rank correlation coefficient will be used (with 95% confidence intervals determined by bootstrapping). Similar correlation methods will be used to explore the associations between PA components (frequency, duration and intensity), TIR, nocturnal TIR and glucose variability.

A binary indicator will be developed indicating whether a participant met clinical guidelines in the observed week based on accelerometry data (60 minutes of MVPA +VPA on valid days observed). Receiver operator characteristic (ROC) curves will be calculated for each self-report tool of interest and this binary indicator. Area under the ROC curve (AUC) and their 95% confidence intervals will be calculated for each tool and compared using DeLong’s method for comparing correlated AUC (11). For each tool, the optimal cut-point will be determined by finding the coordinate with the greatest sum of sensitivity and specificity.

The proportion (and 95% confidence interval) of the sample achieving guidelines will be presented. Linear regression models will be conducted to: i) determine sociodemographic and clinical predictors of MVPA and VPA and; ii) explore the relationship between PA levels and glucose control. Where residuals are non-normally distributed, transformations will be applied, and the model will be conducted using the transformed outcome measure.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/02/2022
Actual
25/04/2022
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
14/04/2023
Actual
Sample size
Target
110
Accrual to date
55
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 310049 0
Charities/Societies/Foundations
Name [1] 310049 0
Diabetes Australia
Country [1] 310049 0
Australia
Primary sponsor type
Government body
Name
Child and Adolescent Health Service
Address
15 Hospital Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 311098 0
None
Name [1] 311098 0
Address [1] 311098 0
Country [1] 311098 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309744 0
Child and Adolescent Health Service HREC
Ethics committee address [1] 309744 0
Ethics committee country [1] 309744 0
Australia
Date submitted for ethics approval [1] 309744 0
17/08/2021
Approval date [1] 309744 0
20/10/2021
Ethics approval number [1] 309744 0

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

Contacts
Principal investigator
Name 115238 0
Dr Craig Taplin
Address 115238 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 115238 0
Australia
Phone 115238 0
+61 08 6456 5243
Fax 115238 0
Email 115238 0
[email protected]
Contact person for public queries
Name 115239 0
Shaun Teo
Address 115239 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 115239 0
Australia
Phone 115239 0
+61 08 6456 8078
Fax 115239 0
Email 115239 0
[email protected]
Contact person for scientific queries
Name 115240 0
Shaun Teo
Address 115240 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 115240 0
Australia
Phone 115240 0
+61 08 6456 8078
Fax 115240 0
Email 115240 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.