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Trial registered on ANZCTR


Registration number
ACTRN12612000470897
Ethics application status
Approved
Date submitted
21/03/2012
Date registered
30/04/2012
Date last updated
18/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Decreasing screen-based entertainment in young children: The Family@play study
Scientific title
Decreasing screen-based entertainment in young children: The Family@play study
Secondary ID [1] 279781 0
Nil
Universal Trial Number (UTN)
U1111-1127-5205
Trial acronym
Family@play
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Screen-based entertainment (SBE) 285658 0
Sedentary behaviour 285672 0
Condition category
Condition code
Public Health 285836 285836 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Time spent in screen-based entertainment (SBE) has been shown to be associated with adverse health and cognitive outcomes even in young children. This project therefore aims to examine the feasibility, acceptability and potential efficacy of a program to reduce screen-based entertainment in young children. Twenty-thirty families will be recruited into the study and the intervention will be delivered to parents in intact groups over a 6-week period. That is, existing groups such as parents attending a particular swimming lesson class or local playgroup, will be approached to participate in the program to ensure a familiar support base amongst parent group.

The intervention consists of six weekly one hour group-based sessions. In each session, participants will set a goal aimed to reduce their young child’s screen-based entertainment which they will implement during the week following the session. Each family will provide data (child height/weight, parent survey, objectively assessed physical activity) three times (baseline, completion of program, 10 weeks post intervention). Each data collection meeting will take approximately 15 minutes and will occur at a time and location convenient to the participant (such as their home, during or adjacent to their playgroup/lesson, or other time/location convenient). During the data collection visits, children will be weighed and measured following standardised protocols. Activity monitors to measure overall physical activity (accelerometer) and time in different postures such as sitting and standing (inclinometer) will be fitted to participating children. Parents will be provided with an information sheet about the monitors and a log sheet to complete during the time their child wears the monitors. Six sessions will be delivered across the intervention period at the physical location where each group was recruited. Intervention sessions will be scheduled either immediately before or after the groups' usual attendance time. Following baseline data collection, a computer generated program will be used to randomly select two of the four groups to participate in the program from August to September 2012. The remaining two groups will participate in an enhanced program (following feedback on the program from the first two groups) in February to March 2013.

Sessions will focus on three primary components: a) non-selectively decreasing SBE by use of budgeting, removing SBE options from children's bedrooms; b) selectively reducing SBE by setting rules/boundaries around use, and limiting participation based on context (only when child is not eating); and c) displacing SBE with other activities such as reading, imaginary games, etc. Content for group sessions will include: clarification of parents' values regarding their! child's health and well being; factors which influence children's development/well-being/health; changing and influencing children's behaviours; review of baseline results of current SBE use in their child; consequences of excessive SBE use to health and other outcomes; benefits of lower levels of SBE, such as social interaction, language development; building motivation and skills to reduce SBE including self-monitoring, goal setting, outcome and efficacy expectancies; awareness of good/bad SBE content; self-efficacy (barrier identification and goal-setting to overcome barriers); and support strategies within each group. Group sessions will also discuss the home-based activities to be undertaken by families and will use an anticipatory guidance approach (where expected challenges are identified and options to manage these are discussed prior to them being encountered) to facilitate group-based problem solving to possible challenges. By peer-based problem solving, participant! s may be more open in discussing challenges and more willing to accept advice from their peers. SMS messaging will be used between group sessions to support adherence to goals. A weekly internet blog site will also be available to support adherence and allow participants to post comments. A healthy afternoon tea and childcare for children and siblings will be provided during the group session.
Intervention code [1] 284098 0
Behaviour
Intervention code [2] 284102 0
Prevention
Intervention code [3] 284114 0
Lifestyle
Comparator / control treatment
Wait-list Control. In the initial phase of the intervention, two groups will receive the treatment while two groups act as controls. Once post-intervention (immediately following the conclusion of the program) and follow-up measures (10 weeks post program completion) are taken, the control group will participate in the program.
Control group
Active

Outcomes
Primary outcome [1] 286349 0
Screen-based entertainment is assessed by detailed time use diary on four days
Timepoint [1] 286349 0
Immediate conclusion of the program (June 2012) and 10 weeks post intervention (late August).
Primary outcome [2] 286350 0
Objectively measured postural position (sitting, lying, standing, walking) will be assessed using activPAL accelerometers
Timepoint [2] 286350 0
Immediate conclusion of the program (June 2012) and 10 weeks post intervention (late August).
Secondary outcome [1] 295645 0
Family functioning/parenting strategies for supporting healthy behaviors in their child as assessed by a parent survey.
Timepoint [1] 295645 0
Immediate conclusion of the program (June 2012) and 10 weeks post intervention (late August).
Secondary outcome [2] 295649 0
Adiposity (height and weight, body mass index) will be assessed. Height and weight will be objectively measured using a calibrated set of electronic scales and portable stadiometer. Body mass index will be calculated from measured height and weight.
Timepoint [2] 295649 0
Immediate conclusion of the program (June 2012) and 10 weeks post intervention (late August).
Secondary outcome [3] 295732 0
Parent self efficacy for supporting healthy behaviors in their child as assessed by a parent survey.
Timepoint [3] 295732 0
Immediate conclusion of the program (June 2012) and 10 weeks post intervention (late August).

Eligibility
Key inclusion criteria
Participating families will have one child aged two or three years who exceeds the Australian recommendation for SBE of one hour or less per day. Participating parents will be willing, able and available to attend the group sessions when scheduled, and be willing to be randomised into either the intervention or control group. Intact groups will have five or more families willing to participate.
Minimum age
24 Months
Maximum age
47 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are excluded from this study according to age (<2 or >3.999) and if they meet Australian screen-based entertainment recommendations (<1h/d).

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)
Participants in this intervention will be 20-32, two- to three-year-old children and their parents. Participants will be recruited through intact groups. That is, existing groups such as parents attending a particular swimming lesson class or local playgroup, will be approached to participate in the program. In total, four groups of five to eight participants each will be recruited. Once baseline measures are complete, two of the four groups will be randomly selected to receive the treatment from August – September 2012. A computer generated program will be used to randomly assign the groups to either intervention or control conditions. The remaining two groups will act as controls and will receive the program once all measures (post-intervention, follow-up) are completed. The control group will participate in an enhanced program from February to March 2013. The program will be enhanced following feedback from the intervention group at the end of their participation in the program.

The allocation will be concealed as it will be done by central randomization by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be completed following baseline measurements to minimise withdrawal. Participant groups will be randomised using a computer-based random number-producing algorithm to either the intervention group (two intact groups, 10-16 participant families) or the wait list control group (two intact groups, 10-16 participant families). To prevent allocation bias, staff taking measurements, will be kept blind to the allocation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Wait list control - both control and intervention groups will receive the intervention; controls will receive the intervention once all data has been collected (post-intervention, follow-up) and no further data will be collected once they have participated in the program.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 4897 0
2500
Recruitment postcode(s) [2] 4902 0
2505
Recruitment postcode(s) [3] 4899 0
2516
Recruitment postcode(s) [4] 4903 0
2517
Recruitment postcode(s) [5] 4900 0
2518
Recruitment postcode(s) [6] 4904 0
2518
Recruitment postcode(s) [7] 4898 0
2519
Recruitment postcode(s) [8] 4901 0
2525

Funding & Sponsors
Funding source category [1] 284563 0
University
Name [1] 284563 0
The University of Wollongong (Faculty of Education)
Address [1] 284563 0
Northfields Avenue
Wollongong
New South Wales 2522
Country [1] 284563 0
Australia
Primary sponsor type
Individual
Name
Trina Hinkley
Address
Deakin University
221 Burwood Hwy
Burwood Vic 3125
Country
Australia
Secondary sponsor category [1] 283510 0
Individual
Name [1] 283510 0
Tony Okely
Address [1] 283510 0
Northfields Avenue
Wollongong
New South Wales 2522
Country [1] 283510 0
Australia
Secondary sponsor category [2] 283511 0
Individual
Name [2] 283511 0
Dylan Cliff
Address [2] 283511 0
Northfields Avenue
Wollongong
New South Wales 2522
Country [2] 283511 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286580 0
University of Wollongong/South Eastern Sydney & Illawarra Area Health Service Human Research Ethics Committee
Ethics committee address [1] 286580 0
University of Wollongong
Northfields Avenue
Wollongong NSW 2500
Ethics committee country [1] 286580 0
Australia
Date submitted for ethics approval [1] 286580 0
30/11/2011
Approval date [1] 286580 0
02/02/2012
Ethics approval number [1] 286580 0
HE11/474

Summary
Brief summary
Time spent in screen-based entertainment has been shown to be associated with adverse health and cognitive outcomes even in young children. Recent evidence suggests that a large proportion of young children exceed recommendations for screen-based entertainment. This project therefore aims to examine the feasibility, acceptability and potential efficacy of a program to reduce screen-based entertainment in young children. The intervention will be delivered to parents in intact groups over a 10-week period.

Both the intervention and control groups will participate in the program and therefore we hypothesise that all participants will see improvements in the targeted outcomes. These include but are not limited to decreased screen-based entertainment, easier application of rules to support healthy behaviours and increased parental self-efficacy. Children may also display increases in physical activity and decreased sitting time. Participants’ results concerning their height and weight and time in screen-based entertainment will be forwarded to parents upon completion of analysis.
Trial website
Trial related presentations / publications
Hinkley T, Cliff DP, Okely AD. Reducing electronic media use in 2-3 year-old children: the Family@play pilot randomised controlled trial. BMC Public Health. 2015; 15(779).
Public notes

Contacts
Principal investigator
Name 33668 0
Dr Trina Hinkley
Address 33668 0
Deakin University
221 Burwood Hwy
Burwood Vic 3125
Country 33668 0
Australia
Phone 33668 0
+613 9251 7723
Fax 33668 0
Email 33668 0
trina.hinkley@deakin.edu.au
Contact person for public queries
Name 16915 0
Dr Trina Hinkley
Address 16915 0
Deakin University
221 Burwood Hwy
Burwood Vic 3125
Country 16915 0
Australia
Phone 16915 0
+613 9251 7723
Fax 16915 0
Email 16915 0
trina.hinkley@deakin.edu.au
Contact person for scientific queries
Name 7843 0
Dr Trina Hinkley
Address 7843 0
Deakin University
221 Burwood Hwy
Burwood Vic 3125
Country 7843 0
Australia
Phone 7843 0
+613 9251 7723
Fax 7843 0
Email 7843 0
trina.hinkley@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary