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Trial registered on ANZCTR


Registration number
ACTRN12625000183482
Ethics application status
Approved
Date submitted
8/01/2025
Date registered
17/02/2025
Date last updated
17/02/2025
Date data sharing statement initially provided
17/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Active-Prem: Exercise Participation in Early Childhood for Children Born Very Preterm.
Scientific title
Active-Prem: Exercise Participation in Early Childhood for Children Born Very Preterm- A Type 1 Effectiveness-Implementation Hybrid Randomized Controlled Trial
Secondary ID [1] 313647 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Active-Prem RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children born very preterm 336214 0
Physical inactivity 336215 0
Condition category
Condition code
Physical Medicine / Rehabilitation 332747 332747 0 0
Other physical medicine / rehabilitation
Reproductive Health and Childbirth 332748 332748 0 0
Complications of newborn
Neurological 333130 333130 0 0
Other neurological disorders
Public Health 333131 333131 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Active-Prem group

The Active-Prem intervention comprises six key steps (each described using the TIDiER format)

Step 1)
Physical activity participation goal setting
Why? (rationale): Goal setting is recognised as an important and effective strategy for behaviour change, including in physical activity participation interventions for children.

What: Physical activity participation goals will be set using the Canadian Occupational Performance Measure (COPM).

Who provided: Physiotherapist or Occupational Therapist.

How (mode of delivery): Goal setting will take place using a motivational interview conversation format with a healthcare professional (member of the study team) and a parent/caregiver. Goal setting will take approximately 20-40 minutes to complete.

Where: Video conferencing or phone call.

When and how much: During the baseline assessment period. Note: this step is completed by both intervention and control groups.

Tailoring: Individualised goal-setting.


Step 2)
Active Start Active Prems parent program
Why? (rationale): The parent program is designed to address key barriers and facilitators to children born preterm’s participation in physical activity identified from previous research and prioritised through the co-design process,

What: This co-designed program aims to support parents to better support their child’s participation in community based physical activity. The program consists of self-directed learning and peer support. Self-Directed Learning includes knowledge content, goal setting and suggested activities. Topics covered in this content include: What is Active-Prem?, Benefits of physical activity, modelling physical activity at home, communicating about your child in recreational physical activity settings, advocating for your child, and addressing common worries and concerns. Peer support includes interactive online sessions (delivered via video conferencing software) and discussion boards (on program website). The online interactive sessions are designed to provide a space for parents to ask questions and problem solve, as well as learn about a particular topic.

Who provided: The program content is written/presented by experts in each content area: parents of children born very preterm, physical activity coaches, physiotherapists, occupational therapists, and psychologists.

How (mode of delivery): Website (Self-directed content and discussion board) and online video conferencing (online interactive sessions). There are 4 modules of self-directed content, each to be completed individually and by a specific time point (e.g. module 2 should be completed before choosing an activity). There is 1 optional module (addressing common concerns) which parents can access anytime if/when it is relevant for them. The Peer support sessions are group-based to provide a peer support system.

Where: The parent program will be delivered online to promote accessibility and scalability.
When and how much: The parent program will start after randomisation into the intervention group and continue throughout the intervention period until the completion of the term of physical activity (step 6). The Self-directed Learning consists of approximately 4hrs of content, presented as 4 modules. Modules 1-3 (3hrs) are designed to be completed prior to the Introductory Session, while module 4(1hr) is designed to be completed during the term of activity. An optional module (common concerns; 1hr) will be available throughout the whole program. Peer support will be provided through one ‘Welcome to Active-Prem’ online session (1 hour; compulsory) and two subsequent check-in sessions during the term of activity (approximately 60 minutes; optional). An online discussion forum will provide additional means of connected and peer support.

Tailoring: The module addressing common concerns is optional, and available throughout the program for parents to access if and when they would like to. Most aspects of the Peer Support are optional. Parents can choose whether to participate in the discussion board conversations or join sessions during the term of activity.


Step 3) Matching
Why? (rationale): Our previous research indicates choice of activity was an important component for acceptable physical activity interventions. Furthermore, children are more likely to engage and participate in physical activities which they enjoy- emphasizing the importance of being able to choose something they believe will be fun.

What: Children will be individually matched with a coach in their local community. Matched coaches will need to be eligible and willing to participate in Active-Prem as a coach.

Who provided: Matching will be facilitated by a member of our research team.

How (mode of delivery): Our research team will recruit coaches on a 1:1 basis.

Where: n/a

When and how much: Matching occurs prior to term of activity.

Tailoring: Matching will be based on the children’s and family’s physical activity preference.


Step 4)
Coaching Essentials: Premature Children in Sport

Why? (rationale): Lack of knowledge of preterm birth and skills for including children with disabilities have been identified as significant barriers to participation in physical activity for children born very preterm.

What: The overall goal of this program is to improve coaches’ knowledge, skills, confidence to better include preschool-aged children born very preterm in their classes. The program includes Self-Directed Learning and optional Coach Support Workshops. Self-Directed Learning includes knowledge content, tasks and assessments. Topics covered in this content include: Understanding prematurity, Understanding key outcomes for children born prematurely, Supporting physical skill development, Supporting social, emotional & behavioural skill development, Developing goals & lesson objectives, and Communication with the team around the child. Coach Support Workshops are designed to provide a supportive space to problem-solve challenges across the Coaching Essentials course and/or Active Prem project, and to facilitate a community of practice, where coaches already in the program can provide mentoring opportunities for less experienced coaches.

Who provided: The program content written/presented by experts in each content area: parents of children born very preterm, physical activity coaches, physiotherapists, occupational therapists, and psychologists.

How (mode of delivery): The program will be delivered online; self directed learning will be delivered via an online educational platform (FutureLearn) and optional coach support workshops will be delivered via online video conferencing.

Where: The intervention will be delivered online to promote accessibility and scalability.

When and how much: The Coaching essentials: Premature children in sport course will be open to individual coaches from enrolment in the study until the conclusion of the matched child’s term of activity. Coaches recruited into the Active-Prem program will need to complete the online co-designed Coaching Essentials: Premature Children in Sport program prior to the commencement of the term of physical activity. The Self-directed Learning is 8hrs of content presented in four 2hr modules. Coaches complete this content at their own pace. The Coach Support Workshops will be 1hr long and are offered 6-8 times across the year at a variety of times to suit coaches’ schedules.

Tailoring: Self-directed Learning is designed to be completed within approximately 4 weeks. However, this duration can be flexible based on individual preferences and circumstances.
Coach Support Workshops are optional and coaches can choose to attend as many of them as they feel they need (titrating their own support).


Step 5)
Introductory session
Why? (rationale): The introductory session has been included to address a number of perceived barriers to successful inclusion of children born very preterm in community based physical activities. These barriers include coach knowledge of individual children’s support needs and strengths, parent knowledge of expectations of the activity and how they can best prepare their child.

What: Children and parents will attend an introductory session with their matched coach. This session will allow parents and children to meet the coach, discuss the child’s individual support needs and allow the child and family to become familiar with the environment and activity.
The Active Start Active Prems parent program includes information and tasks to prepare for the introductory session. Likewise, the Coaching Essentials: Premature Children in Sport program contains information and activities (including planning the session) that must be completed prior to the introductory session.

Who provided: Delivered by the participating matched coach.

How (mode of delivery): Face to face. Children and parent/carer with their matched coach.

Where: At the location of their chosen physical activity (e.g. at the sports club).

When and how much: This session will occur prior to step 6. This session will be approx. 60 minutes in duration; and includes ‘getting to know you’ time, and tailored introduction to foundational skills of activity.

Tailoring: Introductory Sessions will be individualised depending on the needs and preferences of families/coaches. If more than one family enrolled in Active-Prem is matched to the same coach, the introductory session may be delivered in a group format.


Step 6)
Term of physical activity
Why? (rationale): Integrating the Active-Prem intervention into already existing physical activity classes in the local community enhances the likelihood that improved physical activity participation will be sustainable for children and families. Furthermore, this intervention approach is more likely to be implementable and scalable (if the intervention is effective) through embedding Active-Prem into local communities. This approach has been successfully trialled in a feasibility study using dance classes.

What: Children will attend one preschool term of their chosen activity facilitated by their matched coach. Children will be integrated into publicly available physical activity classes. One term of the activity will be subsidized by the study to minimise financial burden.

Who provided: Coach who has completed the Coaching Essentials: Premature Children in Sport program.

How (mode of delivery): Face to face group physical activity class.

Where: At the location of their chosen physical activity (e.g. at the sports club).

When and how much: Once per week for the duration of a preschool term. Preschool terms are usually 8-10 weeks in length.

Tailoring: Families may choose to continue the activity (at their own cost) after the study has concluded.

Intervention code [1] 330244 0
Behaviour
Intervention code [2] 330245 0
Lifestyle
Comparator / control treatment
Name: Physical activity goal setting with a physiotherapist or occupational therapist (Goal Setting).

Why? (rationale): Goal setting is recognised as an important and effective strategy for behaviour change, including in physical activity participation interventions for children.

What: Physical activity participation goals will be set using the Canadian Occupational Performance Measure (COPM).

Who provided: Physiotherapist or Occupational Therapist.

How (mode of delivery): Goal setting will take place using a motivational interview conversation format with a healthcare professional (member of the study team) and a parent/caregiver. Goal setting will take approximately 20-40 minutes to complete.

Where: Video conferencing or phone call.

When and how much: During the baseline assessment period. Note: this step is completed by both intervention and control groups.

Tailoring: Individualised goal-setting.
Control group
Active

Outcomes
Primary outcome [1] 340283 0
Objectively measured physical activity participation
Timepoint [1] 340283 0
Baseline; Post-intervention (primary objective); 12-months post-baseline. Note on timepoints: Post-intervention: A ‘typical week’ after the ‘activity term’ has concluded, and before the end of the subsequent preschool term. 12-months post-baseline: A ‘typical week’ within the preschool term that occurs 12-months post-baseline. A typical week is defined as a week during which a parent reports that the child is participating in their usual activities and usual routines (e.g. not a week in which the family are on holiday or a week during which routines are altered for other reasons) All preschool terms, including the ‘activity term’ refer to Victorian Government School Terms, which vary from approximately 8-11 weeks
Secondary outcome [1] 443607 0
Change in score from baseline to post-intervention on the Canadian Occupational Performance Measure (physical activity goal setting).
Timepoint [1] 443607 0
Baseline; post-intervention Post-intervention: A ‘typical week’ after the ‘activity term’ has concluded, and before the end of the subsequent preschool term. A typical week is defined as a week during which a parent reports that the child is participating in their usual activities and usual routines (e.g. not a week in which the family are on holiday or a week during which routines are altered for other reasons) All preschool terms, including the ‘activity term’ refer to Victorian Government School Terms, which vary from approximately 8-11 weeks
Secondary outcome [2] 443608 0
Parent-reported physical activity participation
Timepoint [2] 443608 0
Baseline; post-intervention; 12-months post-baseline Notes on timepoints: Post-intervention: A ‘typical week’ after the ‘activity term’ has concluded, and before the end of the subsequent preschool term. 12-months post-baseline: A ‘typical week’ within the preschool term that occurs 12-months post-baseline. A typical week is defined as a week during which a parent reports that the child is participating in their usual activities and usual routines (e.g. not a week in which the family are on holiday or a week during which routines are altered for other reasons) All preschool terms, including the ‘activity term’ refer to Victorian Government School Terms, which vary from approximately 8-11 weeks
Secondary outcome [3] 443609 0
Parent-reported child behaviour
Timepoint [3] 443609 0
Baseline; post-intervention; 12-months post-baseline Notes on timpoints: Post-intervention: A ‘typical week’ after the ‘activity term’ has concluded, and before the end of the subsequent preschool term. 12-months post-baseline: A ‘typical week’ within the preschool term that occurs 12-months post-baseline. A typical week is defined as a week during which a parent reports that the child is participating in their usual activities and usual routines (e.g. not a week in which the family are on holiday or a week during which routines are altered for other reasons) All preschool terms, including the ‘activity term’ refer to Victorian Government School Terms, which vary from approximately 8-11 weeks
Secondary outcome [4] 443610 0
Parent perceived barriers and facilitators to supporting their child’s community-based physical activity participation.
Timepoint [4] 443610 0
Baseline; post-intervention. Note on timepoints: Post-intervention: A ‘typical week’ after the ‘activity term’ has concluded, and before the end of the subsequent preschool term. A typical week is defined as a week during which a parent reports that the child is participating in their usual activities and usual routines (e.g. not a week in which the family are on holiday or a week during which routines are altered for other reasons) All preschool terms, including the ‘activity term’ refer to Victorian Government School Terms, which vary from approximately 8-11 weeks
Secondary outcome [5] 443611 0
Coach-perceived effectiveness of the Active-Prem Coaching Essentials: Premature children in sport program at improving their knowledge, skills and confidence to successfully and meaningfully include children born preterm into their preschool-aged classes. This is a composite outcome.
Timepoint [5] 443611 0
Baseline; post-intervention (at the conclusion of the school term)
Secondary outcome [6] 443612 0
Acceptability of Active-Prem intervention from the perspectives of parents/carers randomised to the intervention group.
Timepoint [6] 443612 0
Post-randomisation; post-intervention ( at the conclusion of the school term); 12-months post-baseline
Secondary outcome [7] 443613 0
Acceptability of Active-Prem from the perspective of children randomised to the intervention group.
Timepoint [7] 443613 0
At conclusion of each attended physical activity class.
Secondary outcome [8] 443614 0
Fidelity of Active-Prem classes
Timepoint [8] 443614 0
2 points during the term (class #4 and class #8)
Secondary outcome [9] 443615 0
Fidelity of Active Start Active Prems parent program (parents/carers in intervention group only)
Timepoint [9] 443615 0
Measured throughout intervention
Secondary outcome [10] 443616 0
Fidelity of the Coaching Essentials: Premature children in sport
Timepoint [10] 443616 0
Measured throughout the intervention.
Secondary outcome [11] 443617 0
Feasibility of Active-Prem
Timepoint [11] 443617 0
Measured throughout study
Secondary outcome [12] 443618 0
Implementation barriers and enablers for Active-Prem
Timepoint [12] 443618 0
Post-intervention
Secondary outcome [13] 443619 0
Cost effectiveness of Active-Prem
Timepoint [13] 443619 0
Baseline; post-intervention; 12-months post-baseline.

Eligibility
Key inclusion criteria
There are two participant groups in this trial:
I. Preschool age (3-5 years) children born very preterm (<32 weeks’ gestation) and their parent (at least one parent must participate in the study, however more than 1 parent can access the Active Start Active Prems parent program if they wish).
II. Coaches or teachers of community-based physical activities for preschool age children (referred to as coaches)

Children born very preterm and their parent/carer
Children and parents will be enrolled in the study as a parent-child dyad. This is because the intervention consists of both the Active Start Active Prems parent program and the child’s participation in the community-based physical activity. More than one child from a single family may be eligible for the study, and so more than one parent-child dyad may include the same parent. Each parent-child dyad will be recruited into the trial only if they both meet all inclusion criteria and none of the exclusion criteria listed below. All parent-child dyads from the same families will be assigned the same intervention.

i. Children born at <32 weeks’ gestation.
ii. Children between 3 years to 5 years of age at the time of enrolment in the study.
iii. Children able to independently ambulate, including with an aid (e.g. ankle-foot orthoses)
iv. Child and their participating parent are planning to reside in Victoria for the duration of the intervention.
v. Parent age >18 years at the time of enrolment.
vi. Parent who is comfortable completing the online Active Start Active Prems parent program in English, as the written and audio content of the program is delivered in English.
vii. Child and their participating parent able to participate in the intervention program for a 6-month period.

Coaches.
Coaches will be recruited on a case-by-case basis for each parent-child dyad allocated to the intervention arm of the RCT based on location and physical activity preferences. Therefore, all coaches will participate in the intervention.

i. Teaching or coaching a regularly scheduled (at least 1/week) physical activity class for preschool age children that can be reasonably expected to run for the duration of the intervention period.
ii. Teaching or coaching in Victoria, Australia.
iii. Able and willing to complete the online Active-Prem coach program delivered in English.
iv. Have at least 1 year of experience coaching or teaching physical activity, or equivalent (e.g. assistant coaching, disability/teaching role) to preschool age children.
v. Have a valid Working with Children Check
vi. Have a valid First Aid Certificate (or a staff member who will be present during the activity who is the designated first aider)

There is no limit to the age of parents/carers or coaches participating.
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children born very preterm and their parent/carer

i. Children who have any medical condition, or other health related reason, that precludes safe participation in physical activity.
ii. Any child with planned medical procedures during the intervention period that precludes safe participation in physical activity.


Coaches:

i. greater than or equal to 18 years of age at the time of recruitment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be computer generated using block randomisation with variable block sizes and stratified by multiple birth., with multiples randomised to the same group. Participating children will be randomised to the Active-Prem or goal-setting group 1:1 ratio, using web-based randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Estimation
As we are conducting a type 1 hybrid design, the study will be powered based on the intervention effectiveness primary outcome: minutes spent stepping per day (averaged over 7 days) measured by accelerometry immediately post-intervention. This study will require 204 children in total (approx. 102 per arm) to have 80% power at a two-sided 5% level to detect a mean difference of 30 minutes of stepping per day between the Active-Prem and Goal Setting group, a difference considered to be clinically meaningful. This calculation assumes the standard deviation of time spent stepping per day is 64 mins in each arm based upon our previous research, allows for 20% drop out and accounts for an expected 25% of children being multiples (twins/triplets) with an intra-cluster correlation of 0.80.

Analysis of primary objective: The estimand of interest is the mean difference in average minutes spent stepping per day measured by accelerometry during the post-intervention period, between the Active-Prem and Goal Setting groups. This will be estimated using linear regression, adjusted for multiple birth (which is a stratification factor in the randomisation). The model will be fitted using generalised estimating equations to account for the correlation between siblings (e.g. twins) within families and robust (sandwich) standard errors will be used to estimate the 95% confidence interval (CI).

Analysis of secondary objectives:

Effectiveness: The primary analysis (using a treatment policy approach to handle intercurrent events) will be repeated using minutes spent stepping per day at 12 months post-baseline to assess whether the effects of the intervention are maintained at 6 months. Similar analyses to those used for the primary analysis will be carried out to estimate the effect of the intervention on the MBQ-C and the COPM both post-intervention and at 12 months post-baseline (MBQ-C only).
Effectiveness of the Active Prem Coaching Essentials: Premature children in sport program at improving coach behaviour to successfully and meaningfully include children born VPT in their classes, measured using the DIBQ, will be summarised using descriptive statistics and visual representations in the intervention group. Likewise, parent perceptions of barriers and facilitators to supporting their child’s physical activity will be analysed descriptively and compared between the Active-Prem and the Goal Setting groups. Estimated intervention effects for secondary outcomes will be interpreted with caution as the study is powered for the primary outcome.

Implementability: Quantitative measures of acceptability, feasibility and fidelity will be summarised using descriptive statistics (data from intervention group only). Frequencies and percentages will be presented for categorical data, for example, the acceptability of Active-Prem.

Cost-effectiveness: The economic evaluation will be conducted from the healthcare sector perspective with one-year time horizon and reported following the Consolidated Health Economic Evaluation Reporting Standards 2022. The incremental cost-effectiveness ratio (ICER) will be calculated as the cost per quality-adjusted life year gained from the intervention compared with the Goal Setting group and will be compared with a willingness-to-pay threshold at A$50,000 to determine the cost-effectiveness of the intervention. A bootstrap method with 1000 replications will be used to generate the 95% CI of the ICER and a cost-effectiveness plane.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/04/2025
Actual
Date of last participant enrolment
Anticipated
31/01/2027
Actual
Date of last data collection
Anticipated
31/01/2028
Actual
Sample size
Target
204
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318114 0
Government body
Name [1] 318114 0
Department of Health - Medical Research Future Fund
Country [1] 318114 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 320493 0
None
Name [1] 320493 0
Address [1] 320493 0
Country [1] 320493 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316759 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 316759 0
Ethics committee country [1] 316759 0
Australia
Date submitted for ethics approval [1] 316759 0
19/12/2024
Approval date [1] 316759 0
10/02/2025
Ethics approval number [1] 316759 0

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

Contacts
Principal investigator
Name 138922 0
Prof Alicia Spittle
Address 138922 0
The University of Melbourne 7th Floor Alan Gilbert Building 161 Barry Street, Parkville, Victoria, 3052
Country 138922 0
Australia
Phone 138922 0
+61 413599862
Fax 138922 0
Email 138922 0
aspittle@unimelb.edu.au
Contact person for public queries
Name 138923 0
Alicia Spittle
Address 138923 0
The University of Melbourne 7th Floor Alan Gilbert Building 161 Barry Street, Parkville, Victoria, 3052
Country 138923 0
Australia
Phone 138923 0
+61 413599862
Fax 138923 0
Email 138923 0
aspittle@unimelb.edu.au
Contact person for scientific queries
Name 138924 0
Alicia Spittle
Address 138924 0
The University of Melbourne 7th Floor Alan Gilbert Building 161 Barry Street, Parkville, Victoria, 3052
Country 138924 0
Australia
Phone 138924 0
+61 413599862
Fax 138924 0
Email 138924 0
aspittle@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent not obtained from participants


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24431Study protocol    We plan to publish protocol in open access journal



Results publications and other study-related documents

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