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Trial registered on ANZCTR


Registration number
ACTRN12610000087055
Ethics application status
Approved
Date submitted
21/01/2010
Date registered
27/01/2010
Date last updated
26/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial to assess the efficacy of an intervention to increase the physical activity levels of children attending long day care.
Scientific title
The effect of a long day care physical activity intervention versus standard care on child physical activity.
Secondary ID [1] 1327 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood overweight and obesity 256646 0
Condition category
Condition code
Public Health 256808 256808 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention has been developed by an advisory group with representation from the Department of Community Services, NSW Health, local authorised supervisors, health promotion practitioners, paediatric researchers and physical activity experts. Specifically, the intervention, will be implemented in long day care services over a 16 week period and will consist of the following components:

1. Limiting small screen recreation and sedentary behaviours:
Services will be supported to develop and implement a policy requiring that children two years and over limit time watching or using electronic media and that all children are not sedentary for longer than 30 minutes at a time (except when sleeping) . The policy will also require services to integrate physical activities into the curriculum, program structured time for physical activity, ensure staff are appropriately trained in physical activity and engage parents in policy development and physical activity programming.

2. Engagement in Daily fundamental movement skill (FMS) development: To ensure appropriate developmental milestones are met, services will engage children in age and developmentally appropriate FMS activities. FMS development will be supported through both programmed structured and unstructured free play activities. Engagement in skill development will also be facilitated through the provision of verbal cues and affirmation by staff.

3.Increasing opportunities for active play: Intervention services will be supported to provide a combination of structured (including dance, active games and active transitions) and unstructured child initiated opportunities (socio-dramatic props, equipment, provocations) for children to engage in active play . Staff practices will involve being active participants in child initiated play, and providing verbal prompts to encourage and promote active play.

4.Supportive environment for active play: Services will be supported to modify equipment availability and setup of indoor and outdoor environments.

5. Integrated learning: Opportunities for children to learn about physical activity will be programmed and integrated across learning areas.

Services will be supported by the research team to implement the intervention. Specifically service staff will attend a full day training workshop provided access to online professional development. The training will be conducted by a childhood physical activity consultant with experience working with childcare services. At the training services will receive a resource package including practical games, dvd’s and ideas to facilitate implementation of intervention components. Services will also be encouraged to communicate with and engage parents in service level changes, to engage child physical activity and implement supportive policies. Services will receive standardised scheduled support calls, and emails/faxes to support implementation.
Intervention code [1] 255883 0
Prevention
Intervention code [2] 255884 0
Lifestyle
Intervention code [3] 255885 0
Behaviour
Comparator / control treatment
No Treatment, standard care- Participating services randomised to the wait list control group will receive the intervention after collection of follow-up data.
Control group
Active

Outcomes
Primary outcome [1] 257673 0
Physical Activity level measured by pedometers step counts.
Timepoint [1] 257673 0
At baseline and at 4-6 weeks post intervention period (12-14 weeks after baseline).
Secondary outcome [1] 262982 0
Long Day Care centre staff physical activity practices. Staff practices involving verbal prompts, structured and unstructured activity, role modelling, small screen recreation and child sedentary activities. Assessed via staff self complete survey and adapted version of the Environment and Policy Assessment Observation instrument (EPAO). Adapted to include physical activity items only.
Timepoint [1] 262982 0
At baseline and at 4-6 weeks post intervention period (12-14 weeks after baseline).
Secondary outcome [2] 262983 0
Long Day Care Centre Staff knowledge of physical activity, small screen recreation and sedentary behaviour recommendations. Assessed via staff self complete survey.
Timepoint [2] 262983 0
At baseline and at 4-6 weeks post intervention period (12-14 weeks after baseline).
Secondary outcome [3] 262984 0
Service organisational and environmental characteristics. Policy, indoor and outdoor environment, staff training, curriculum, fixed and portable play equipment. Assessed via adapted version of the Environment and Policy Assessment Observation instrument (EPAO). Adapted to include physical activity items only.
Timepoint [3] 262984 0
At baseline and at 4-6 weeks post intervention period (12-14 weeks after baseline).
Secondary outcome [4] 262985 0
Adverse events. Data will be collected to identify specific potential adverse events in the form of staff or child injury requiring documentation at the service level as a result of the intervention. This data will be collected via self report through the staff survey with an item included asking staff to recall the approximate number of child and staff injuries requiring documentation in the last month.
Timepoint [4] 262985 0
At baseline and at 4-6 weeks post intervention period (12-14 weeks after baseline).

Eligibility
Key inclusion criteria
Long Day Care Services -For a service to be eligible it will be within the Newcastle and lake Macquarie geographic region of NSW Australia and have a minimum total number of children enrolled aged 3-6 years of at least 30.

Children For children within the service to be eligible to participate they will be aged 3-6 years, have parental consent and attend care on the designated day that data collection occurs.
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Long Day Care Services: Services serving special needs populations will be excluded from participating in the trial given the specialist care required for such children and the likelihood of a differential effect in this population group. Services where the Authorised Supervisor is a member of the program advisory group will also be excluded from the trial given the potential for contamination regarding intervention components.

Children: Children at the service with special needs will be excluded from participating in the trial.

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)
Long Day Care Services:
A current list of all LDCS in the Newcastle and Lake Macquarie regions which have licensed places for 3 to 6 year olds will be obtained from the NSW Department of Health. Eligible services will be randomly selected from the list, and the order in which they are approached to participate will also be randomly determined (using a random number function in Excel) by an independent statistician. The Authorised Supervisor of eligible LDCS will be sent a letter informing them about the study and requesting permission to recruit parents through their service. Consent will be obtained through the supervisor faxing or posting a consent form back to the research team. Within two weeks from the initial information letters being sent, a study research assistant will telephone Authorised Supervisors (that have not yet returned their consent form) to answer any questions they may have and to remind them to return their form, confirming their consent or otherwise.


Children:
A member of the research team blinded to group allocation and who will not be involved in intervention delivery will arrange for recruitment packs (one per parent of each enrolled child 3 to 6 years) to be delivered to each participating long day care service (LDCS). Distribution of these packs to parents will occur via methods considered most effective and appropriate by the Authorised Supervisor in engaging parents (e.g. placed in children’s pigeon holes or lockers, or handed directly to parents at drop-off or pick-up). The pack will include a promotional flier explaining the study to parents at consenting LDCS. The flier will be distributed to parents prior to distribution of consent material and will inform parents of the trial and their opportunity to participate. The recruitment pack will contain an information sheet, consent form and return envelope. Parents will be asked to return the consent form in the envelope provided to a drop-box at the preschool (supplied by the research team). Parents will have two to three weeks to return their consent form. Parents will be provided the direct phone number of a member of the research team to ask questions regarding research participation. One to two weeks after delivery of the recruitment packs, reminder letters will be disseminated via the same channels, reminding parents of the study and the opportunity to participate.

Random allocation of services to groups will occur following recruitment of children from all long day care services. Staff involved in recruitment of long day care services and children will be blind to the group allocation. Allocation to groups will be conducted by an independent statistician, at a centralised location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician using a randomisation function in Excel will perform a stratified block randomisation. LDCS will be randomised in a 1:1 ratio (intervention:control) in randomly sequenced blocks of between 2,4 or 6 preschools. The statistician will otherwise not be involved in data collection or intervention delivery.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2010
Actual
26/02/2010
Date of last participant enrolment
Anticipated
Actual
4/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 256371 0
Charities/Societies/Foundations
Name [1] 256371 0
Hunter Medical Research Institute
Country [1] 256371 0
Australia
Primary sponsor type
Individual
Name
Dr Luke Wolfenden
Address
Locked Bag 10 Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 251686 0
Government body
Name [1] 251686 0
Hunter New England Population Health
Address [1] 251686 0
Hunter New England Population Health
Locked Bag 10, Wallsend NSW 2287
Country [1] 251686 0
Australia
Other collaborator category [1] 1053 0
Individual
Name [1] 1053 0
Associate Professor Philip Morgan
Address [1] 1053 0
School of Education
Faculty of Education and Arts
University of Newcastle
Callaghan NSW 2308
Country [1] 1053 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258439 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 258439 0
Ethics committee country [1] 258439 0
Australia
Date submitted for ethics approval [1] 258439 0
Approval date [1] 258439 0
09/11/2009
Ethics approval number [1] 258439 0
09/09/16/5.12

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

Contacts
Principal investigator
Name 30745 0
Dr Luke Wolfenden
Address 30745 0
Hunter New England Population Health
Locked bag 10 Wallsend, NSW, 2287
Country 30745 0
Australia
Phone 30745 0
+61 2 4985 5168
Fax 30745 0
Email 30745 0
Luke.Wolfenden@hnehealth.nsw.gov.au
Contact person for public queries
Name 13992 0
Dr Luke Wolfenden
Address 13992 0
Locked bag 10
Wallsend, NSW, 2287
Country 13992 0
Australia
Phone 13992 0
+61 2 4985 5168
Fax 13992 0
Email 13992 0
Luke.Wolfenden@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 4920 0
Meghan Finch
Address 4920 0
Locked bag 10
Wallsend, NSW, 2287
Country 4920 0
Australia
Phone 4920 0
+61 2 49246131
Fax 4920 0
Email 4920 0
Meghan.Finch@hnehealth.nsw.gov.au

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.