Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000836538
Ethics application status
Approved
Date submitted
19/06/2024
Date registered
5/07/2024
Date last updated
5/07/2024
Date data sharing statement initially provided
5/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Move to Improve: A single-arm, pragmatic feasibility trial of an individualised physical activity program for children with chronic conditions
Scientific title
Move to Improve: A single-arm, pragmatic feasibility trial of an individualised physical activity program for children with chronic conditions
Secondary ID [1] 312311 0
Nil
Universal Trial Number (UTN)
U1111-1308-5681
Trial acronym
M2I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 334062 0
Cancer 334063 0
Post-burn injuries 334064 0
Cerebral palsy 334065 0
Condition category
Condition code
Metabolic and Endocrine 330728 330728 0 0
Diabetes
Cancer 330729 330729 0 0
Any cancer
Injuries and Accidents 330730 330730 0 0
Burns
Neurological 330731 330731 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Move to Improve has been co-designed by consumers, researchers and health professionals, and the program will be individually tailored to support children to develop physical activity goals that are fun and sustainable. The multidisciplinary Move to Improve team will help children to build motivation, skills and the confidence required to lead an active lifestyle. The Move to Improve program team will consist of a Senior Exercise Physiologist, Senior Physiotherapist, Senior Clinical Psychologist, Senior Dietician, Enrolled Nurse, Allied Health Assistant, Advanced Trainee, and Aboriginal Health Worker. The Move to Improve team will work with the child and family to develop an individualised physical activity program aligned with the participants’ goals as identified using the Canadian Occupational Performance Measure (COPM) tool. During the initial assessment, the Move to Improve program team will work with the family to draft a rough plan for the 8 sessions. The Move to Improve program team will then have approximately 10 days to develop a more structured plan based on this initial conversation. This 8 week plan will be flexible, and likely to change throughout the intervention, in order to reflect how the family is going and the child’s individual circumstances and needs. The program will broadly aim to build towards meeting the physical activity guidelines of 60 minutes per day of moderate-vigorous physical activity and will include a combination of aerobic, strength training, flexibility, and coordination exercises. Participants will be encouraged to follow the program over the 8-week duration of the intervention. To support participation in the individualised program and address specific barriers to physical activity, the Move to Improve team will provide additional resources (e.g., information sheets) as required.

Over the course of the 8-week intervention, participants will have access to 1 hour/week one-to-one sessions from the Move to Improve program team to support implementation of the program (e.g., addressing any barriers) and achievement of identified goals. Additional psychology and dietetic support will be provided to participants for whom these are identified barriers to physical activity participation. Based on initial screening from the referral, questionnaires and medical chart review, clinical psychology will provide consultation and liaison to families and their treating teams about mental health support and also about utilising physical activity to improve mood, anxiety and general wellbeing. Based on the initial screening and diet history, the dietician will conduct one-to-one consultations with families of children identified as needing dietetic input during the program. Dietetic support may include (but is not limited to) individual dietary goals and diabetes management support as required.

During this period, programs may be adjusted by the Move to Improve team based on the child’s progression towards the predetermined end goal. One-to-one sessions may take place at Perth Children’s Hospital, via Telehealth, in community settings, or home visits depending on clinical judgment of what is required to support the child’s progression towards their physical activity goals. The Move to Improve team will capture adherence in the form of session notes by prompting families on their engagement in the prescribed program and physical activity more broadly since the previous session. Feasibility of intervention delivery will be assessed by the Move to Improve research team using the RE-AIM framework.

A parent/primary caregiver of participating children will also be included in the study. Their involvement will be to respond to online parent-report questionnaires and complete physical activity diaries to record their child's physical activity).
Intervention code [1] 328782 0
Lifestyle
Intervention code [2] 328921 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338490 0
Habitual physical activity (time spent in moderate-vigorous physical activity). This will be assessed as a composite outcome.
Timepoint [1] 338490 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow up (calculated from end of intervention)
Primary outcome [2] 338491 0
Quality of Life
Timepoint [2] 338491 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow up (calculated from end of intervention)
Primary outcome [3] 338492 0
Goal Attainment
Timepoint [3] 338492 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow up (calculated from end of intervention)
Secondary outcome [1] 436120 0
Knowledge about physical activity participation
Timepoint [1] 436120 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow-up (calculated from end of intervention)
Secondary outcome [2] 436121 0
Body composition (% body fat)
Timepoint [2] 436121 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow up (calculated from end of intervention)
Secondary outcome [3] 436122 0
Aerobic capacity testing
Timepoint [3] 436122 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow up (calculated from end of intervention)
Secondary outcome [4] 436123 0
Grip strength
Timepoint [4] 436123 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow up (calculated from end of intervention)
Secondary outcome [5] 436124 0
Motor function
Timepoint [5] 436124 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow up (calculated from end of intervention)
Secondary outcome [6] 436125 0
Behavioural and emotional challenges. This will be assessed as a composite outcome.
Timepoint [6] 436125 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow up (calculated from end of intervention)
Secondary outcome [7] 436126 0
Parental stress
Timepoint [7] 436126 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow up (calculated from end of intervention)
Secondary outcome [8] 436127 0
Parents' Physical Activity Level
Timepoint [8] 436127 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow up (calculated from end of intervention)
Secondary outcome [9] 436128 0
Quality of LIfe (Cerebral Palsy Specific)
Timepoint [9] 436128 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow up (calculated from end of intervention)
Secondary outcome [10] 436129 0
Fear of hypogylcaemia
Timepoint [10] 436129 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow up (calculated from end of intervention)
Secondary outcome [11] 436130 0
Burns Specific Quality of Life
Timepoint [11] 436130 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow up (calculated from end of intervention)
Secondary outcome [12] 436889 0
Body composition (% muscle mass)
Timepoint [12] 436889 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow-up (calculated from end of intervention)
Secondary outcome [13] 436890 0
Attitude towards participation in physical activity
Timepoint [13] 436890 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow-up (calculated from end of intervention)
Secondary outcome [14] 436891 0
Motivation to participate in physical activity
Timepoint [14] 436891 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow-up (calculated from end of intervention)
Secondary outcome [15] 436892 0
Confidence to participate in physical activity
Timepoint [15] 436892 0
Baseline, post-intervention, 6-month follow-up (calculated from end of intervention), and 12-month follow-up (calculated from end of intervention)

Eligibility
Key inclusion criteria
Paediatric patients aged between 5 and 18 years with one of four chronic health conditions:
Type 1 Diabetes: diagnosed for >6 months
Cancer: treated for any type of cancer, members of the Late Effects and Survivorship Program (5 years from end of treatment), ambulant
Post-burn injuries: at least 6 weeks post-burn injury (outpatients)
Cerebral palsy: ambulant (Gross Motor Functional Classification level I-III of all motor types)

A parent/primary caregiver of children meeting the eligibility criteria above will also be included in the study (their involvement will be to respond to online parent-report questionnaires and complete physical activity diaries to record their child's physical activity).
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if:
They have limited ability to communicate insight into a preferred future (needs, wants and desires) in spoken English and/or through an interpreter or augmentative and alternative communication and/or children with moderate-to-severe intellectual disability as defined by the 10th revision of the International Statistical Classification of Diseases and Related Health Problems as IQ<50
They have uncontrolled epilepsy (as this may impact on safety to engage in certain PA)
They have a severe visual impairment or blindness (defined as 6/60 or lower vision)
They have severe asthma exacerbated by exercise that is not controlled with medications under an asthma management plan
They have a life expectancy of <6 months
They are pregnant
They are scheduled for any major surgeries throughout the project that are likely to impact ability to participate in Move to Improve, on advice of medical team
Aged =18 years

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/07/2024
Actual
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26667 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 42707 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 316703 0
Charities/Societies/Foundations
Name [1] 316703 0
Perth Children's Hospital Foundation
Country [1] 316703 0
Australia
Funding source category [2] 316704 0
Charities/Societies/Foundations
Name [2] 316704 0
Stan Perron Charitable Foundation
Country [2] 316704 0
Australia
Primary sponsor type
Hospital
Name
Perth Children's Hospital, Child and Adolescent Health Service
Address
Country
Australia
Secondary sponsor category [1] 318907 0
None
Name [1] 318907 0
Address [1] 318907 0
Country [1] 318907 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315483 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 315483 0
Ethics committee country [1] 315483 0
Australia
Date submitted for ethics approval [1] 315483 0
08/02/2024
Approval date [1] 315483 0
15/03/2024
Ethics approval number [1] 315483 0

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

Contacts
Principal investigator
Name 134834 0
Prof Elizabeth Davis
Address 134834 0
Perth Children's Hospital, Hospital Avenue, Nedlands WA 6009
Country 134834 0
Australia
Phone 134834 0
+61 8 6456 5031
Fax 134834 0
Email 134834 0
[email protected]
Contact person for public queries
Name 134835 0
Emily Davey
Address 134835 0
Perth Children's Hospital, Hospital Avenue, Nedlands WA 6009
Country 134835 0
Australia
Phone 134835 0
+61 8 6456 8784
Fax 134835 0
Email 134835 0
[email protected]
Contact person for scientific queries
Name 134836 0
Hamsini Sivaramakrishnan
Address 134836 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands WA 6009
Country 134836 0
Australia
Phone 134836 0
+61 8 6319 1811
Fax 134836 0
Email 134836 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data fields will be made publicly available
When will data be available (start and end dates)?
Data fields will be made available after the results have been published. No end date has been determined.
Available to whom?
Data fields publicly available. De-identified data may be available upon reasonable request.
Available for what types of analyses?
Available for any type of analysis.
How or where can data be obtained?
Access subject to approvals by Principal Investigator Professor Elizabeth Davis ([email protected])


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.