Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000346279
Ethics application status
Approved
Date submitted
1/02/2018
Date registered
7/03/2018
Date last updated
7/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Healthy Online Professional Program for Early Learners (HOPPEL) targeting educators in Early Childhood Education Care addressing physical activity and nutrition behaviours of young children
Scientific title
Evidence based technology-mediated professional learning package for Early Childhood Educators: Is there an effect on the physical activity and healthy eating practices of young children enrolled in early childhood?
Secondary ID [1] 293788 0
Nil known
Universal Trial Number (UTN)
U1111-1207-7890
Trial acronym
HOPPEL
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
childhood obesity 306186 0
Condition category
Condition code
Public Health 305580 305580 0 0
Health promotion/education
Diet and Nutrition 305717 305717 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Non drug trial
Topics covered in the face-to-face and online intervention included: theory underpinning HOPPEL project, including Community of Practice. promoting physical activity and reducing sedentary behaviours, introducing 'power/activity breaks' in early childhood education and care settings, teaching fundamental motor skills, skills,focusing on healthy eating behaviours, holistic planning, change management, navigating web-based ongoing professional learning,
HOPPEL was a 12-week program with opportunities of extension. The project comprised of a daylong (6 hrs) face-to-face professional learning workshop, followed by 12-weeks of online professional learning. The online element involved asynchronous components including weekly blogs and forums. In addition to these weekly asynchronous sessions, educators participated in three synchronous sessions that were delivered using an online learning platform. Two identical synchronous sessions (i.e. live chat sessions) were facilitated every third week.
The online platform consisted of blogs (posted weekly by research facilitator), forum (space for educators and facilitator to discuss current changes made in early childhood education and care environment based on project content, content related videos, images), live chat sessions ( conducted ever third week),
Facilitator responded to all four posts by participants within 24hr, and monitored the professional content of the posts.
Intervention code [1] 300045 0
Prevention
Intervention code [2] 300252 0
Lifestyle
Intervention code [3] 300253 0
Behaviour
Comparator / control treatment
This study followed the stepped wedge cluster randomised controlled trial design. This meant that randomisation occurs while still allowing all educators the opportunity of undertaking a period of intervention. All services will begin in the control phase and then cross over to the intervention phase over a 12-month period. The control treatment meant that services were unaware of the intervention and the educators followed normal routines, procedures and policies. For the study randomisation occurred at a service level rather than individual participant level. Educators were recruited from 15 early childhood education and care services within one overarching administrating organisation. The stepped wedge design will consist of three groups that each contained 5 randomly allocated services.
Control group
Active

Outcomes
Primary outcome [1] 304464 0
Changes in physical activity of children as a result of educators participating in a blended professional learning program called HOPPEL.


Child level measures:

Actigraph GT3X+ accelerometers was used to measure the intensity (sedentary, light, moderate and vigorous) and duration of physical activity in preschool aged children (2-5 years). All children wore an Actigraph GT3X+ (Actigraph, Florida) tri-axial accelerometers over a week during ECEC hours across four time points within a 12-month period.
Timepoint [1] 304464 0
The stepped wedge design consists of three groups, each comprising of 5 services. Baseline data on all three groups (time point 1) will be collected one month prior to the commencement of the first intervention group (Group 1). The second round of data collection (time point 2) will be conducted 3 months later, whereby group 1 will have post intervention data collected and group 2 will commence intervention. The third round of data collection time point 3) will be conducted 3 months later, whereby group 1 will have post intervention data collected (maintenance phase), group 2 will have post intervention data collected and group 3 will commence intervention. The fourth round of data collection (time point 4) will be conducted 3 months later, whereby group 1 will have post intervention data collected (maintenance phase), group 2 will have post intervention data collected (maintenance phase) and group 3 will have post data collected.

Outcomes will be assessed for group one:
Baseline (collected 1 month prior to group one's commencement intervention)
3-months post commencement of intervention (primary timepoint) and
6-months post commencement of intervention and
9-month post commencement of intervention

Outcomes will be assessed for group two:
3-months post commencement of intervention (primary timepoint) and
6-months post commencement of intervention and
9-month post commencement of intervention

Outcomes will be assessed for group 3:
3-months post commencement of intervention (primary timepoint)

Primary outcome [2] 304717 0
Changes in healthy eating behaviours of children as a result of educators participating in a blended professional learning program called HOPPEL.

Centre level measurements

EPAO
The Environmental and Policy Assessment Observation (EPAO) system was used to objectively assesses the healthy eating behaviours and practices of children attending ECECs. Trained data collectors accessed documents such as written service policies/procedures on healthy eating guidelines, menus, daily program schedules, curriculum materials on healthy eating, training materials for staff on healthy eating respectively and safety check documents, conduct observational data on healthy eating educators behaviours.
Timepoint [2] 304717 0
The stepped wedge design consists of three groups, each comprising of 5 services. Baseline data on all three groups (time point 1) will be collected one month prior to the commencement of the first intervention group (Group 1). The second round of data collection (time point 2) will be conducted 3 months later, whereby group 1 will have post intervention data collected and group 2 will commence intervention. The third round of data collection time point 3) will be conducted 3 months later, whereby group 1 will have post intervention data collected (maintenance phase), group 2 will have post intervention data collected and group 3 will commence intervention. The fourth round of data collection (time point 4) will be conducted 3 months later, whereby group 1 will have post intervention data collected (maintenance phase), group 2 will have post intervention data collected (maintenance phase) and group 3 will have post data collected.

Outcomes will be assessed for group one:
Baseline (collected 1 month prior to group one's commencement intervention)
3-months post commencement of intervention (primary timepoint) and
6-months post commencement of intervention and
9-month post commencement of intervention

Outcomes will be assessed for group two:
3-months post commencement of intervention (primary timepoint) and
6-months post commencement of intervention and
9-month post commencement of intervention

Outcomes will be assessed for group 3:
3-months post commencement of intervention (primary timepoint)
Primary outcome [3] 304748 0
Assess the acceptability/feasibility of a technology mediated professional learning program.
Baseline - Educators complete Pre and post questionnaires. The pre-questionnaire collected data on their past professional development experiences and the the types of professional learning models they have experienced. For example, online, blended, face-to-face. Post-questionnaire- collected at 3 mths ( group 1 only), 6 mths ( group 2 only ) and 9 months ( group 3 only) . Post-data was collected on what they felt about the following; the strengths and weaknesses of this studies blended professional learning model, quality of professional networking opportunities, the online synchronous forums, the online support and mentoring and the ongoing online professional conversations etc.
Timepoint [3] 304748 0
Baseline (collected one month prior to the group one's commencement of the intervention) and
3-months post commencement of intervention (primary time point)
Secondary outcome [1] 342040 0
Change in levels of duration of physical activity of children aged 2-5 years in early childhood education and care settings

Child level measurement
Data collected at all time points - baseline, 3 months, 6 months and 9 months. Actigraph GT3X+ accelerometers was used to measure the intensity (sedentary, light, moderate and vigorous) and duration of physical activity in preschool aged children (2-5 years). All children wore an Actigraph GT3X+ (Actigraph, Florida) tri-axial accelerometers over a week during ECEC hours across four time points.
Timepoint [1] 342040 0
Actigraph GT3X+ accelerometers was used to measure the intensity (sedentary, light, moderate and vigorous) and duration of physical activity in preschool aged children (2-5 years). All children wore an Actigraph GT3X+ (Actigraph, Florida) tri-axial accelerometers over a week during ECEC hours across four time points within a 12-month period.

Outcomes will be assessed for group one:
Baseline (collected 1 month prior to group one's commencement intervention)
3-months post commencement of intervention and
6-months post commencement of intervention and
9-month post commencement of intervention

Outcomes will be assessed for group two:
3-months post commencement of intervention and
6-months post commencement of intervention and
9-month post commencement of intervention

Outcomes will be assessed for group 3:
3-months post commencement of intervention

Eligibility
Key inclusion criteria
ECEC services- invited to participate from one overarching early childhood education and care provider/organisation to participate in the study.

Educators- all educators employed in chosen early childhood education and care provider/organisation s will be invited to participate in this project, and

Children- all children (aged 2-5y) who are enrolled in the ECEC will be invited to participate.
Minimum age
2 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Educators not employed under overarching organization, children younger than 1 years and older than 5 years who are not enrolled in participating services. Children with physical disabilities.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled 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)
Simple randomisation - service names pulled out of a hat
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
Used a stepped-wedge cluster randomised trial (SWCRT) design in which data will be collected at 3 levels: A sample size of 15 services, divided into 3 clusters (5 ECECs per cluster), was used. A compete design with three time points and clusters will be used and randomised to blocks. All cluster sizes will be the same size and independent. All services will initially begin in a ‘baseline collection period, where no clusters are exposed (Jan-Mar 2015), and sequentially, crossover to the intervention’. All ECECs will begin in the control condition, and then each cluster will shift to the intervention at sequential time points.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sampled size powered on number of services required for the study opposed to number of children. University statistician determined number of services based on previous studies and literature.

Secondary outcomes of study used multilevel linear regression analysis and multi-level logistical regression analyses, adjusting for clustering at a centre, maintenance period. Statistical analysis can be performed using STATA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
1/02/2016
Date of last data collection
Anticipated
Actual
16/12/2016
Sample size
Target
100
Accrual to date
Final
111
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 298405 0
University
Name [1] 298405 0
University of Wollongong
Country [1] 298405 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
University of Wollongong
Northfields Ave
Wollongong 2522
Early Start
Country
Australia
Secondary sponsor category [1] 297772 0
None
Name [1] 297772 0
N/A
Address [1] 297772 0
N/A
Country [1] 297772 0
Other collaborator category [1] 279895 0
Other
Name [1] 279895 0
Lady Gowrie Tasmania
Address [1] 279895 0
346 Macquarie St,
South Hobart, TAS, 7004.
Country [1] 279895 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299402 0
Human Research Ethics committee
Ethics committee address [1] 299402 0
Ethics committee country [1] 299402 0
Australia
Date submitted for ethics approval [1] 299402 0
03/08/2015
Approval date [1] 299402 0
16/10/2015
Ethics approval number [1] 299402 0
HD15/356

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

Contacts
Principal investigator
Name 80278 0
Prof Tony Okely
Address 80278 0
University of Wollongong
Northfieds Ave
Wollongong 2522
NSW
Early Start, Building 21
Country 80278 0
Australia
Phone 80278 0
+61 02 42214641
Fax 80278 0
Email 80278 0
[email protected]
Contact person for public queries
Name 80279 0
Tony Okely
Address 80279 0
University of Wollongong
Northfieds Ave
Wollongong 2522
NSW
Early Start, Building 21
Country 80279 0
Australia
Phone 80279 0
+61 02 42214641
Fax 80279 0
Email 80279 0
[email protected]
Contact person for scientific queries
Name 80280 0
Tony Okely
Address 80280 0
University of Wollongong
Northfieds Ave
Wollongong 2522
NSW
Early Start, Building 21
Country 80280 0
Australia
Phone 80280 0
+61 02 42214641
Fax 80280 0
Email 80280 0
[email protected]

No information has been provided regarding IPD availability


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.