Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000969369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
21/07/2026
Date registered
Help: Date registered
6/08/2026
Date last updated
Help: Date last updated
6/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
6/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Move to Improve 2: Implementation and scale up of a physical activity service for children with chronic health conditions
Scientific title
A pragmatic hybrid type II trial examining the scale up of the Move to Improve intervention on physical activity, goal attainment, and quality of life in children with chronic health conditions
Additional trial identifiers [1] 317907 0
Nil
Universal Trial Number (UTN)
U1111-1344-4148
Trial acronym
M2I2
Related trial records
ACTRN12624000836538 - pilot study

Health condition
Health condition(s) studied:
Paediatric chronic health conditions 342853 0
Condition category
Condition code
Cancer 338965 338965 0 0
Any cancer
Cardiovascular 338966 338966 0 0
Other cardiovascular diseases
Metabolic and Endocrine 338967 338967 0 0
Diabetes
Injuries and Accidents 338968 338968 0 0
Burns
Neurological 338969 338969 0 0
Other neurological disorders
Inflammatory and Immune System 338970 338970 0 0
Other inflammatory or immune system disorders
Renal and Urogenital 338971 338971 0 0
Other renal and urogenital disorders
Respiratory 338972 338972 0 0
Other respiratory disorders / diseases
Metabolic and Endocrine 338973 338973 0 0
Other metabolic disorders
Human Genetics and Inherited Disorders 338974 338974 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Move to Improve is a physical activity intervention co-designed by young people with chronic health conditions, primary caregivers, health professionals, and researchers. An Expert Reference Group comprising health professionals (medical, allied health) and researchers, and interviews with children and primary caregivers informed the co-design process and associated materials. Children with chronic health conditions and their parents participated in four 2-hour workshops delivered over 4 weeks. Workshop activities included facilitated group discussions, interactive brainstorming activities, case studies, and storyboards. Families also reviewed research materials, including assessment protocols and questionnaires. Recommendations and feedback were incorporated into the Move to Improve intervention design and implementation.

The Move to Improve intervention is goal-directed, individualised, and delivered by a multidisciplinary team to promote and support active living behaviours for children with chronic health conditions. Participants will receive one 45 minute, one-to-one physical activity session each week for 8 weeks. Physical activity sessions will be delivered by a Senior Exercise Physiologist or Senior Physiotherapist. Support is provided by a Senior Clinical Psychologist and Senior Dietitian as required for participation in physical activity and health and well-being. Each participant will engage in an individualised program designed to progress towards physical activity goals, build knowledge and confidence in being active, and support ongoing physical activity participation. Dependent on participant goals, physical activity sessions may include aerobic and strength exercise, fundamental movement skills, sport-specific skills, participation-focused activities, and/or a combination of these.

Intervention sessions may take place at Perth Children’s Hospital, in community settings, or via telehealth (dependent on physical activity goals, program progression, and/or family preference). Family members will be encouraged to be involved in sessions to increase physical activity knowledge and confidence, and to support ongoing physical activity behaviours for the child and family. Intervention adherence will be promoted via goal-setting, family involvement, clinical support, attendance monitoring and follow-up, and tailoring of sessions to participant interests, abilities, and clinical status.
Intervention code [1] 334754 0
Lifestyle
Description of the comparator or control
No control group. Participants complete 2 baseline assessments (8 week non-intervention phase) to act as their own control.
Control group
Active

Outcomes
Primary outcome [1] 346209 0
Physical activity goal performance
Timepoint [1] 346209 0
Initial baseline (T0), intervention baseline (T1), post-completion of 8 week intervention (T2, primary timepoint), 3 month follow up (T4, calculated from end of intervention)
Primary outcome [2] 346210 0
Daily time spent in moderate-vigorous physical activity
Timepoint [2] 346210 0
Initial baseline (T0), intervention baseline (T1), post-completion of 8 week intervention (T2, primary timepoint), 3 month follow up (T4, calculated from end of intervention)
Primary outcome [3] 346211 0
Quality of Life
Timepoint [3] 346211 0
Initial baseline (T0), intervention baseline (T1), post-completion of 8 week intervention (T2, primary timepoint), 3 month follow up (T4, calculated from end of intervention)
Secondary outcome [1] 465020 0
Physical literacy
Timepoint [1] 465020 0
Initial baseline (T0), intervention baseline (T1), post-completion of 8 week intervention (T2), 3 month follow up (T4, calculated from end of intervention)
Secondary outcome [2] 465021 0
Aerobic capacity
Timepoint [2] 465021 0
Initial baseline (T0), intervention baseline (T1), post-completion of 8 week intervention (T2), 3 month follow up (T4, calculated from end of intervention)
Secondary outcome [3] 465022 0
Grip strength
Timepoint [3] 465022 0
Initial baseline (T0), intervention baseline (T1), post-completion of 8 week intervention (T2), 3 month follow up (T4, calculated from end of intervention)
Secondary outcome [4] 465023 0
Psychological wellbeing
Timepoint [4] 465023 0
Initial baseline (T0), intervention baseline (T1), post-completion of 8 week intervention (T2), 3 month follow up (T4, calculated from end of intervention)
Secondary outcome [5] 465024 0
Cardiovascular health
Timepoint [5] 465024 0
Initial baseline (T0), intervention baseline (T1), post-completion of 8 week intervention (T2), 3 month follow up (T4, calculated from end of intervention)
Secondary outcome [6] 465025 0
Body composition
Timepoint [6] 465025 0
Initial baseline (T0), intervention baseline (T1), post-completion of 8 week intervention (T2), 3 month follow up (T4, calculated from end of intervention)
Secondary outcome [7] 465026 0
Parental physical activity support
Timepoint [7] 465026 0
Initial baseline (T0), intervention baseline (T1), post-completion of 8 week intervention (T2), 3 month follow up (T4, calculated from end of intervention)
Secondary outcome [8] 465027 0
Parent physical activity
Timepoint [8] 465027 0
Initial baseline (T0), intervention baseline (T1), post-completion of 8 week intervention (T2), 3 month follow up (T4, calculated from end of intervention)
Secondary outcome [9] 465029 0
Fear of hypogylcaemia
Timepoint [9] 465029 0
Initial baseline (T0), intervention baseline (T1), post-completion of 8 week intervention (T2), 3 month follow up (T4, calculated from end of intervention)
Secondary outcome [10] 465610 0
Physical activity goal satisfaction. This is an additional primary outcome
Timepoint [10] 465610 0
Initial baseline (T0), intervention baseline (T1), post-completion of 8 week intervention (T2, primary timepoint), 3 month follow up (T4, calculated from end of intervention)
Secondary outcome [11] 465611 0
Adoption of Move to Improve
Timepoint [11] 465611 0
Upon study completion
Secondary outcome [12] 465612 0
Implementation of Move to Improve
Timepoint [12] 465612 0
Upon study completion
Secondary outcome [13] 465613 0
Sustainability of Move to Improve
Timepoint [13] 465613 0
(i) start and end of recruitment phase (ii) end of recruitment phase

Eligibility
Key inclusion criteria
A current Perth Children's Hospital (PCH) outpatient living with a primary diagnosis of a chronic health condition
Aged 5-17 years living in the Perth metropolitan region
Willing and able to attend in-person physical activity sessions at trial sites (community sites or PCH)
Ability to communicate (needs, wants, and desires) in spoken English or through an interpreter or augmentative and alternative communication
Receiving outpatient services through of one of the following hospital departments: Endocrinology; Kids Rehab; Burns; Oncology and Haematology; Adolescent Medicine; Cardiology; Gastroenterology; General Paediatrics; Nephrology; Neurology; Respiratory; Rheumatology; Metabolic Medicine; Dermatology; Immunology; Rare Care Centre
Minimum age
5 Years
Maximum age
17 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Participants will be excluded if they have:
Uncontrolled epilepsy
Severe asthma exacerbated by exercise that is not controlled with medications under an asthma management plan
A life expectancy of <6 months
Are pregnant
Major scheduled surgeries during the program that may impact ability to participate (as advised by treating team)
Any other contraindications to participate in physical activity (as advised by treating team)

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
Implementation data will be analysed descriptively. Primary and secondary outcome data (effectiveness outcomes) will be analysed using linear mixed-effects models to evaluate changes in outcome variables over time, with differences between timepoints computed from estimated marginal means. This will account for individual variability at baseline (as is the case for children with chronic conditions) and other covariates (time-varying variables like seasonal changes), missing data, unequal timing between assessments, and multiple timepoints. Multiple imputation methods will be used, where appropriate, to address missing data. Secondary analyses will adjust for potential confounders (e.g., age, sex) and explore possible moderating effects (e.g., condition type), as data permit. Analytical approaches will be developed in consultation with a statistician to ensure sufficient statistical power (greater than or equal to 0.8) to detect moderate effect sizes and to maintain methodological rigour.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/08/2026
Actual
Date of last participant enrolment
Anticipated
1/11/2027
Actual
Date of last data collection
Anticipated
28/02/2028
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 29851 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 46206 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 322441 0
Charities/Societies/Foundations
Name [1] 322441 0
Perth Children's Hospital Foundation
Country [1] 322441 0
Australia
Funding source category [2] 322450 0
Charities/Societies/Foundations
Name [2] 322450 0
Stan Perron Charitable Foundation
Country [2] 322450 0
Australia
Primary sponsor type
Hospital
Name
Perth Children's Hospital, Child and Adolescent Health Service
Address
Country
Australia
Secondary sponsor category [1] 325368 0
Charities/Societies/Foundations
Name [1] 325368 0
The Kids Research Institute Australia
Address [1] 325368 0
Country [1] 325368 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320934 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 320934 0
Ethics committee country [1] 320934 0
Australia
Date submitted for ethics approval [1] 320934 0
23/02/2026
Approval date [1] 320934 0
05/06/2026
Ethics approval number [1] 320934 0

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

Contacts
Principal investigator
Name 152130 0
Prof Elizabeth Davis
Address 152130 0
Perth Children's Hospital, Hospital Avenue, Nedlands WA 6009
Country 152130 0
Australia
Phone 152130 0
+61 8 6456 5031
Fax 152130 0
Email 152130 0
[email protected]
Contact person for public queries
Name 152131 0
Emily Davey
Address 152131 0
Perth Children's Hospital, Hospital Avenue, Nedlands WA 6009
Country 152131 0
Australia
Phone 152131 0
+61 8 6456 1111
Fax 152131 0
Email 152131 0
[email protected]
Contact person for scientific queries
Name 152132 0
Claire Willis
Address 152132 0
The Kids Research Institute Australia, 15 Hospital Avenue, Nedlands WA 6009
Country 152132 0
Australia
Phone 152132 0
+61 8 6319 1000
Fax 152132 0
Email 152132 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.