Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000972628
Ethics application status
Approved
Date submitted
29/08/2014
Date registered
10/09/2014
Date last updated
30/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pragmatic randomised trial of an intervention to increase childcare service implementation of healthy eating and physical activity promoting policies and practices
Scientific title
The impact of a review and feedback intervention to increase the healthy eating and physical activity policy and practices in centre based child care versus standard care
Secondary ID [1] 285254 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood overweight and obesity 292879 0
Condition category
Condition code
Public Health 293172 293172 0 0
Health promotion/education
Diet and Nutrition 293242 293242 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will seek to increase service implementation of healthy eating and physical activity policies and practices consistent with best practice Australian healthy eating and physical activity guidelines for the childcare setting, and evidence reviews of policies and practices shown to be associated with child healthy eating and physical activity

Five performance review and feedback cycles will be provided to nominated supervisors across a period of 10 months. Each performance review and feedback cycle will include a written feedback report and one telephone feedback discussion. The review process will require service’s nominated supervisor (or other identified lead educator) to complete a brief telephone survey regarding current implementation of the targeted policies and practices. Using this information, feedback will be provided by a support officer (via a face-to-face visit for cycle 1 and by telephone in following cycles.

Services will also receive quarterly interactive email newsletters which will communicate key messages relating to the healthy eating and physical activity policies and practices.

The intervention aims to facilitate the following policies and practice changes

1. Policies: Service will be supported to develop and implement three policies; nutrition policy, physical activity policy and small screen recreation policy (if they have a TV on site).
2. Provision of information to families: Services will be supported to provide information to families from registered health authority about healthy eating, physical activity, limiting screen time.
3. Engagement in Daily fundamental movement skill (FMS) development: Services will be supported to implement a daily fundamental movement skill component into their program.
4. Healthy eating learning experiences: Services will be supported to engage children in a healthy eating learning experience two times per week.
5. Appropriate drinks: Services will be supported to provide appropriate drinks for children every day (only water and plain milk and reduced fat milk for children over 2 years of age.
6. Small screen recreation: Services will be supported to use small screen recreation within their service appropriately, by limiting use for 3 – 5 year olds for educational purposes.
Intervention code [1] 290121 0
Prevention
Intervention code [2] 290122 0
Lifestyle
Intervention code [3] 290123 0
Behaviour
Comparator / control treatment
Usual support - consisting of standard staff development opportunities regarding child health and development which could include staff training or resources.
Control group
Active

Outcomes
Primary outcome [1] 293031 0
The change in prevalence of all targeted service policies and practices from baseline to immediately following the intervention as assessed via telephone interview with Nominated Supervisor/ or key service contact.

Specifically, the policies and practices to be measured include:
i.Service policy (nutrition, physical activity and small screen recreation
ii.Service provides information to families (healthy eating, physical activity, small screen time and breast feeding, where relevant).
iii.Service provides structured and specific learning experiences about healthy eating at least two times/week
iv.Service supplies age appropriate drinks to children
v.Service provides fundamental movement skills activities for children aged 3-5 years every day to at least 90% of children
vi.Service limits use of small screen recreation by children aged 3-5 years for educational purposes and learning experiences
Timepoint [1] 293031 0
At baseline and 1 month after the completion of the intervention
Secondary outcome [1] 310215 0
nil
Timepoint [1] 310215 0
nil

Eligibility
Key inclusion criteria
Centre based child care services: eligible services within the Hunter, Taree and New England geographical areas of NSW Australia will be invited to participate.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include:
*Services already involved in an alternative randomised controlled trial currently underway in the Hunter New England Area Health Service;
*Services already implementing healthy eating and physical activity policies to a high standard (as defined by a government region wide surveillance system) (state-wide program)
*Services catering exclusively for children requiring specialist care; Mobile preschools, Department of Education and Communities preschools.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study information and consent forms will be mailed to services approximately 2 weeks before a telephone call from a research assistant requesting consent to participate in data collection. Randomisation will occur after baseline data collection and will be carried out centrally using a random number function in Mircosoft Excel.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Services will be randomised in a 1:1 ratio to either an intervention or control group by an independent statistician using a computerised random number function .
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2013
Actual
15/08/2013
Date of last participant enrolment
Anticipated
25/09/2013
Actual
25/09/2013
Date of last data collection
Anticipated
Actual
12/12/2014
Sample size
Target
165
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289864 0
Government body
Name [1] 289864 0
Hunter New England Population Health
Country [1] 289864 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Longworth Ave, Wallsend, NSW, 2287
Australia
Country
Australia
Secondary sponsor category [1] 288557 0
None
Name [1] 288557 0
Address [1] 288557 0
Country [1] 288557 0
Other collaborator category [1] 278143 0
University
Name [1] 278143 0
University of Newcastle
Address [1] 278143 0
University Dr, Callaghan NSW 2308
Country [1] 278143 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291585 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 291585 0
Ethics committee country [1] 291585 0
Australia
Date submitted for ethics approval [1] 291585 0
Approval date [1] 291585 0
27/09/2006
Ethics approval number [1] 291585 0
06/07/26/4.04

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

Contacts
Principal investigator
Name 51018 0
Mrs Meghan Finch
Address 51018 0
Hunter New England Population Health
Locked bag 10
Wallsend, NSW, 2287
Country 51018 0
Australia
Phone 51018 0
+61 2 49246131
Fax 51018 0
Email 51018 0
[email protected]
Contact person for public queries
Name 51019 0
Luke Wolfenden
Address 51019 0
Hunter New England Population Health
Locked bag 10
Wallsend, NSW, 2287
Country 51019 0
Australia
Phone 51019 0
+61 2 4985 5168
Fax 51019 0
Email 51019 0
[email protected]
Contact person for scientific queries
Name 51020 0
Meghan Finch
Address 51020 0
Hunter New England Population Health
Locked bag 10
Wallsend, NSW, 2287
Country 51020 0
Australia
Phone 51020 0
+61 2 49246131
Fax 51020 0
Email 51020 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
SourceTitleYear of PublicationDOI
EmbaseA pragmatic randomised controlled trial of an implementation intervention to increase healthy eating and physical activity-promoting policies, and practices in centre-based childcare services: Study protocol.2015https://dx.doi.org/10.1136/bmjopen-2014-006706
EmbaseA randomised controlled trial of performance review and facilitated feedback to increase implementation of healthy eating and physical activity-promoting policies and practices in centre-based childcare.2019https://dx.doi.org/10.1186/s13012-019-0865-7
N.B. These documents automatically identified may not have been verified by the study sponsor.