Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000288921
Ethics application status
Approved
Date submitted
29/01/2020
Date registered
4/03/2020
Date last updated
6/10/2022
Date data sharing statement initially provided
4/03/2020
Date results provided
6/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of companion animal physical activity interventions on children’s health and development
Scientific title
Effect of companion animal physical activity interventions on improving health and developmental outcomes of children aged 5 to 8 years: A pilot study
Secondary ID [1] 300059 0
HAB17-017
Universal Trial Number (UTN)
Trial acronym
PLAYCE PAWS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child physical inactivity
 315579 0
Child social-emotional development 315580 0
Condition category
Condition code
Public Health 313866 313866 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants: Upon registering their interest to participate, parents will be sent a Participant Information Sheet for Parents and a consent form. Once parents have consented to participate, they will be provided with a study information pack which is sent via post. The pack includes the Participant Information Sheet for Parents, covering letters specific for each intervention group describing the intervention in detail, and any other study material pertinent to the intervention group (described below).

Intervention Group 1 (“SMS group”): 50 families will receive personalised mobile phone text messages 3 times a week over 4 weeks to encourage more active play and interaction between the child and the family dog and family dog walking. Prior to the start of the intervention, an intervention information pack on (1) tips and advice on how children should safely interact and play with their dog, (2) indoor and outdoor games the child can play with their dog, and (3) dog-friendly walking trails around Perth, Western Australia, will be posted out to parents.

Intervention Group 2 (“Dog pedometer and SMS group”): 50 families will receive the same text messaging intervention and intervention information pack as Group 1. They will also be provided with a dog pedometer to record the number of dog steps during play or walking, and a personalized dog steps diary for the child to complete.

Data collection will occur at three time points: baseline, 1-month post intervention and 3-months post intervention.
Intervention code [1] 316331 0
Behaviour
Intervention code [2] 316779 0
Lifestyle
Comparator / control treatment
Control group: 50 families will serve as a control group. They will continue their usual routine with dog play and walking during the study period. At the conclusion of the study (i.e. after completing the 3-month post intervention survey), the intervention information pack will be sent to control participants.
Control group
Active

Outcomes
Primary outcome [1] 322258 0
Change in children's dog play

Measured using adapted items from the Healthy Active Preschool Years (HAPPY) parent proxy report survey, Hinkley et al. 2012
Timepoint [1] 322258 0
Baseline, 1 month post intervention (primary endpoint), 3 months post intervention
Primary outcome [2] 322259 0
Change in family dog walking

Measured using adapted items from the Healthy Active Preschool Years (HAPPY) parent proxy report survey, Hinkley et al. 2012
Timepoint [2] 322259 0
Baseline, 1 month post intervention (primary endpoint), 3 months post intervention
Primary outcome [3] 322353 0
Change in children's outdoor play

Measured using parental-report measures of outdoor playtime as developed by Burdette 2004
Timepoint [3] 322353 0
Baseline, 1 month post intervention (primary endpoint), 3 months post intervention
Secondary outcome [1] 378190 0
Change in children unstructured physical activity

Measured using adapted items from the Healthy Active Preschool Years (HAPPY) parent proxy report survey, Hinkley et al. 2012
Timepoint [1] 378190 0
Baseline, 1 month post intervention, 3 months post intervention
Secondary outcome [2] 379761 0
Change in child development outcomes: Strengths and Difficulties Questionnaire (SDQ)

Measured using the Strengths and Difficulties Questionnaire by Goodman, 1997.
Timepoint [2] 379761 0
Baseline, 1 month post intervention, 3 months post intervention
Secondary outcome [3] 379762 0
Change in child development outcomes; Self-Esteem

Measured using the Self-Esteem Scale by Rosenberg 1965
Timepoint [3] 379762 0
Baseline, 1 month post intervention, 3 months post intervention
Secondary outcome [4] 379765 0
Change in child development outcomes: Empathy

Measured using the The Young Children's Empathy Measure by Poresky 1990
Timepoint [4] 379765 0
Baseline, 1 month post intervention, 3 months post intervention
Secondary outcome [5] 379766 0
Change in child development outcomes: Self-Regulation

Measured using the Fast Track Project Child Behavior Questionnaire (2010)
Timepoint [5] 379766 0
Baseline, 1 month post intervention, 3 months post intervention
Secondary outcome [6] 379767 0
Change in child development outcomes: Level of Attachment to their dog

Measured using two tools: Inclusion of Others in the Self (where 'others' indicates the dog) (Aron et al 1991), and the items from the Dog and Physical Activity (DAPA) tool (Cutt et al. 2008)
Timepoint [6] 379767 0
Baseline, 1 month post intervention, 3 months post intervention

Eligibility
Key inclusion criteria
1. Child aged between 5 to 8 years
2. Child should not have a significant condition that would affect participation in physical activity or interacting with the family dog.
3. The family dog is well socialised with the child and other people
4. A parent / guardian should be able to supervise the child to ensure safe dog play and dog walking practices (information is provided).
5. A parent / guardian need to be able to read and understand the study participant information sheet and explain it to the child.
Minimum age
5 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Child not within age group
2. Do not have a dog
3. Family dog has health and/or behavioural issues which may affect playing or walking activities with the child

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation: participants were randomly recruited into staggered blocks
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
Parent and child socio-demographic characteristics and parent-report outcome measures will be reported descriptively. All data will be analysed on an Intention to Treat (ITT) basis. Prior to analysis data will be cleaned and checked. Comparability of groups at baseline will be assessed using socio-demographic variables and compared statistically using chi-squared tests to compare differences in categorical variables and outcome measures, and independent samples t-tests to compare differences in continuous variables. Primary endpoints will be compared between groups using independent samples t-tests and within groups using paired samples t-tests. The impact of intervention will be assessed using multiple linear regression models.
P values of <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/04/2019
Date of last participant enrolment
Anticipated
30/04/2020
Actual
9/05/2021
Date of last data collection
Anticipated
31/08/2020
Actual
13/07/2021
Sample size
Target
150
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 304511 0
Charities/Societies/Foundations
Name [1] 304511 0
Human Animal Bond Research Institute
Country [1] 304511 0
United States of America
Primary sponsor type
Individual
Name
Associate Professor Hayley Christian
Address
Telethon Kids Institute
University of Western Australia, School of Population and Global Health,

Northern Entrance,
Perth Children's Hospital,
15 Hospital Ave,
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 305279 0
Charities/Societies/Foundations
Name [1] 305279 0
Telethon Kids Institute
Address [1] 305279 0
Northern Entrance,
Perth Children's Hospital,
15 Hospital Ave,
Nedlands
WA 6009
Country [1] 305279 0
Australia
Secondary sponsor category [2] 305381 0
University
Name [2] 305381 0
University of Western Australia, School of Population and Global Health,
Address [2] 305381 0
Clifton Street Building,
Clifton St, Nedlands
WA 6009
Country [2] 305381 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304942 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 304942 0
Ethics committee country [1] 304942 0
Australia
Date submitted for ethics approval [1] 304942 0
25/03/2019
Approval date [1] 304942 0
26/03/2019
Ethics approval number [1] 304942 0
RA/4/1/7417

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

Contacts
Principal investigator
Name 98710 0
A/Prof Hayley Christian
Address 98710 0
Telethon Kids Institute
University of Western Australia, School of Population and Global Health,

Northern Entrance,
Perth Children's Hospital,
15 Hospital Ave,
Nedlands
WA 6009
Country 98710 0
Australia
Phone 98710 0
+61 863191040
Fax 98710 0
Email 98710 0
[email protected]
Contact person for public queries
Name 98711 0
Michelle Ng
Address 98711 0
Telethon Kids Institute

Northern Entrance,
Perth Children's Hospital,
15 Hospital Ave,
Nedlands
WA 6009
Country 98711 0
Australia
Phone 98711 0
+61 863191041
Fax 98711 0
Email 98711 0
[email protected]
Contact person for scientific queries
Name 98712 0
Hayley Christian
Address 98712 0
Telethon Kids Institute

Northern Entrance,
Perth Children's Hospital,
15 Hospital Ave,
Nedlands
WA 6009
Country 98712 0
Australia
Phone 98712 0
+61 863191040
Fax 98712 0
Email 98712 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified full dataset
When will data be available (start and end dates)?
Available from 12 months after anticipated project end date, with no end date.
Available to whom?
Academics and research staff
Available for what types of analyses?
Any purpose approved by the Principal Investigator and relevant ethics committees.
How or where can data be obtained?
Please contact the Principal Investigator via email on [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6148Study protocol  [email protected]



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 study protocol for a randomised controlled trial to evaluate the effectiveness of a dog-facilitated physical activity minimal intervention on young children's physical activity, health and development: the PLAYCE PAWS trial.2021https://dx.doi.org/10.1186/s12889-020-10034-7
EmbaseA mobile health intervention to encourage physical activity in children: a randomised controlled trial.2022https://dx.doi.org/10.1186/s12887-022-03336-9
N.B. These documents automatically identified may not have been verified by the study sponsor.