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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]

none

Universal Trial Number (UTN)

none

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

physical activity

sleep

Condition category

Condition code

Public Health

Health promotion/education

Diet and Nutrition

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]

Lifestyle

Intervention code [2]

Behaviour

Intervention code [3]

Prevention

Comparator / control treatment

No support will be provided to the control group.

Control group

Active

Outcomes

Primary outcome [1]

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]

Baseline and 3-month follow up

Secondary outcome [1]

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]

Baseline and 3-month follow up

Secondary outcome [2]

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]

Baseline and 3-month follow up

Secondary outcome [3]

Child BMI- Child BMI will be assessed using parent-reported weight and height

Timepoint [3]

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)

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

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Hunter New England Population Health

Address [1]

Booth Building Longworth Avenue Wallsend 2287 NSW

Country [1]

Australia

Funding source category [2]

University

Name [2]

University of Newcastle

Address [2]

University Drive Callaghan 2308 NSW

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Kookaburra Circuit, New Lambton Heights 2305 NSW

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/06/2016

Approval date [1]

28/06/2016

Ethics approval number [1]

Summary

Brief summary

Previous research to improve physical activity in preschool aged children have resulted in only small improvements in child activity levels. Efforts to improve the impact of physical activity interventions may need to consider targeting other potential determinants of child activity. In the recent years, the relationship between sleep duration and obesity, as well as it's related modifiable risk factors (nutrition and physical activity) has received considerable attention. The current evidence examining the association between sleep duration and physical activity in children however have reported mixed findings and consists primarily  of cross-sectional studies.  Randomised trials provide an opportunity to explore the causal relationship between sleep and child physical activity. The proposed study therefore aims to examine the impact of an intervention targeting sleep duration on child activity levels. The research seeks to answer this question by supporting parents to modify sleep routines in their home and measures the potential impact of such an intervention on child PA and sleep. This study will use a randomised controlled trial study design with 150 children aged between 3-5 years old. Parents of 3- to 5-year-old children attending randomly selected childcare centres in the Hunter New England region of New South Wales, Australia will be approached to participate and randomised to receive an intervention targeting sleep practices and a no intervention control group. Parents in the intervention arm will receive a 3-month intervention consisting of a pre-recorded video module outlining practical tips for establishing and implementing strategies conducive to supporting sleep for their child, one follow up support call to support implementation of those strategies and two text messages to reinforce messages provided in the web link and video. The primary outcome of the trial will be the number of minutes the child spends in moderate to vigorous physical activity assessed using an accelerometer. Secondary outcomes include total time in physical activity, sleep duration and child BMI. All data collection will occur at baseline and approximately 3-months follow up.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Sze Lin Yoong

Address

University of Newcastle.
c/o Hunter New England Population Health
Booth Building Longworth Avenue Wallsend 2287 NSW

Country

Australia

Phone

+61433949140

Fax

serene.yoong@Hnehealth.nsw.gov.au

Contact person for public queries

Name

Serene (Sze Lin) Yoong

Address

University of Newcastle.
c/o Hunter New England Population Health
Booth Building Longworth Avenue Wallsend 2287 NSW

Country

Australia

Phone

+61433949140

Fax

serene.yoong@hnehealth.nsw.gov.au

Contact person for scientific queries

Name

Serene (Sze Lin) Yoong

Address

University of Newcastle.
c/o Hunter New England Population Health
Booth Building Longworth Avenue Wallsend 2287 NSW

Country

Australia

Phone

+61433949140

Fax

serene.yoong@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

Source	Title	Year of Publication	DOI
Embase	A pilot randomized controlled trial examining the impact of a sleep intervention targeting home routines on young children's (3-6 years) physical activity.	2019	https://dx.doi.org/10.1111/ijpo.12481

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically