Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000822482
Ethics application status
Approved
Date submitted
15/06/2016
Date registered
22/06/2016
Date last updated
20/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the impact of targeting sleep on child physical activity levels
Scientific title
A pilot randomised controlled trial assessing the impact of targeting sleep on child physical activity.
Secondary ID [1] 289441 0
none
Universal Trial Number (UTN)
none
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical activity 299135 0
sleep 299136 0
Condition category
Condition code
Public Health 299155 299155 0 0
Health promotion/education
Diet and Nutrition 299213 299213 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parents of children in the intervention group will receive a 3-month intervention supporting them to implement healthy sleep practices for their preschool aged child. The intervention will seek to educate parents about personal and environmental factors aimed to promote positive sleep for their child. The intervention will be developed and delivered by an established organisation who has over 20 years’ experience delivering evidence-based parenting programs.
The sleep support component will consist of a 15 minute online pre-recorded video module that will be sent via email to parents, one 30-minute telephone call and two text messages.
The video resource will outline the importance of sleep generally and in children, good sleep habits, and how to establish them within their household. For example, parents are encouraged to create appropriate environments for bed (including reducing light and noise in the bed room where possible, removing all screens from the child's room, creating safe sleep associations that are independent of the parent). Also included on the webpage will be links to other supporting web-based resources published by reputable organisations including the National Sleep Foundation (on bedroom environment) and Raising Children Network which provide tips on establishing healthy sleep. The link sent to the parents will enable the research team to monitor whether parents click on the resource and how much of the video was watched.

Approximately two weeks from being sent the web-link, parents will also receive one 30-minute telephone call by a trained psychologist to clarify the content of the video, problem solve any barriers to implementing suggested sleep routines and provide practical suggestions to support parents with implementing the practice. Approximately 2 and 4 weeks following the phone call, a text message will be sent to parents. The aim of the text messages will be to reinforce the level of engagement and implementation of strategies for improving child sleeping routines as identified in the phone call.
Both the content of the telephone call and text messages will be tailored to parents level of engagement with the intervention and any reported barriers to implementing suggested changes.
The content of the telephone call and text messages will be summarised on an excel spreadsheet by the personnel delivering the intervention.
Intervention code [1] 295037 0
Lifestyle
Intervention code [2] 295038 0
Behaviour
Intervention code [3] 295094 0
Prevention
Comparator / control treatment
No support will be provided to the control group.
Control group
Active

Outcomes
Primary outcome [1] 298634 0
Child moderate to vigorous physical activity: Total minutes that the child spends in moderate to vigorous physical activity will be assessed using an accelerometer. The child will be asked to wear the accelerometer for at least five days to provide three days of usable data.
Timepoint [1] 298634 0
Baseline and 3-month follow up
Secondary outcome [1] 324817 0
Child Total Physical Activity: Total volume of activity (assessed via counts per 15 sec epoch) will be assessed using accelerometers. The child will be asked to wear the accelerometer for at least five days to provide three days of usable data.
Timepoint [1] 324817 0
Baseline and 3-month follow up
Secondary outcome [2] 324818 0
Child sleep duration - Child sleep duration will primarily be measured by parent self-report via telephone interview. This information will also be measured using parent reported daily logs
Timepoint [2] 324818 0
Baseline and 3-month follow up
Secondary outcome [3] 324819 0
Child BMI- Child BMI will be assessed using parent-reported weight and height
Timepoint [3] 324819 0
Baseline and 3-month follow up

Eligibility
Key inclusion criteria
Parents will be recruited from childcare centres in the Hunter New England Area. To be eligible, each participant must be a parent of a child aged 3 to 5 years attending a participating preschool, must reside with that child for at least four days a week (in order to implement the suggested sleep strategies) and must be able to understand spoken and written English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children with an intellectual or physical impairment that may impact on their physical activity capacity or prevent them from complying with data collection protocols will be excluded.

Parents will be excluded from participation if they do not live with the child for four or more days as they will be unable to implement the recommended strategies.

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)
Following baseline data collection, a statistician independent of the research team, will allocate parents to either the intervention or control condition in a 1:1 ratio, using a computerised random number generator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following baseline data collection, a statistician independent of the research team, will allocate parents to either the intervention or control condition in a 1:1 ratio, using a computerised random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Time between baseline data collection and receipt of intervention may vary between 2- 6 weeks.
This is a pilot study designed to test the feasibility of research methods and procedures. While not primarily designed for hypothesis testing due to the potentially small sample size, the trial will provide important information about the direction and estimated treatment effect that can be used to inform sample size calculation for a larger trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Minutes of moderate-to-vigorous physical activity will be determined using age-specific child-validated equations. Linear mixed effects regression modelling will be undertaken including time (baseline vs 3 months), group (intervention vs control) and group X time interaction as fixed independent variables to assess the impact of the intervention on MVPA. Analysis will be done under an intention to treat framework.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2016
Actual
10/08/2016
Date of last participant enrolment
Anticipated
29/07/2016
Actual
28/09/2016
Date of last data collection
Anticipated
Actual
3/02/2017
Sample size
Target
150
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293815 0
Government body
Name [1] 293815 0
Hunter New England Population Health
Country [1] 293815 0
Australia
Funding source category [2] 293816 0
University
Name [2] 293816 0
University of Newcastle
Country [2] 293816 0
Australia
Primary sponsor type
Individual
Name
Dr Serene (Sze Lin) Yoong
Address
c/o Hunter New England Population Health
Booth Building Longworth Avenue Wallsend 2287 NSW
Country
Australia
Secondary sponsor category [1] 292645 0
None
Name [1] 292645 0
Address [1] 292645 0
Country [1] 292645 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295248 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 295248 0
Ethics committee country [1] 295248 0
Australia
Date submitted for ethics approval [1] 295248 0
10/06/2016
Approval date [1] 295248 0
28/06/2016
Ethics approval number [1] 295248 0

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

Contacts
Principal investigator
Name 66686 0
Dr Sze Lin Yoong
Address 66686 0
University of Newcastle.
c/o Hunter New England Population Health
Booth Building Longworth Avenue Wallsend 2287 NSW
Country 66686 0
Australia
Phone 66686 0
+61433949140
Fax 66686 0
Email 66686 0
[email protected]
Contact person for public queries
Name 66687 0
Serene (Sze Lin) Yoong
Address 66687 0
University of Newcastle.
c/o Hunter New England Population Health
Booth Building Longworth Avenue Wallsend 2287 NSW
Country 66687 0
Australia
Phone 66687 0
+61433949140
Fax 66687 0
Email 66687 0
[email protected]
Contact person for scientific queries
Name 66688 0
Serene (Sze Lin) Yoong
Address 66688 0
University of Newcastle.
c/o Hunter New England Population Health
Booth Building Longworth Avenue Wallsend 2287 NSW
Country 66688 0
Australia
Phone 66688 0
+61433949140
Fax 66688 0
Email 66688 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 pilot randomized controlled trial examining the impact of a sleep intervention targeting home routines on young children's (3-6 years) physical activity.2019https://dx.doi.org/10.1111/ijpo.12481
N.B. These documents automatically identified may not have been verified by the study sponsor.