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Trial registered on ANZCTR


Registration number
ACTRN12617000967381
Ethics application status
Approved
Date submitted
22/06/2017
Date registered
5/07/2017
Date last updated
3/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physical and Affective Wellbeing Study of dog owners (PAWS)
Scientific title
Physical and Affective Wellbeing Study of dog owners (PAWS): a semi-randomised controlled feasibility pilot trial
Secondary ID [1] 292259 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PAWS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preventing any condition that may negatively impact physical and mental health 303776 0
Condition category
Condition code
Other 303147 303147 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: The effects of dog ownership on adult physical activity, cardiovascular and metabolic health, and psychosocial wellbeing

In this pilot study, we will test the feasibility of the recruitment mechanism, participant group allocation, and proposed measurement methods of a flexible design semi-randomised controlled trial examining the effects of dog ownership on adult physical activity, cardiovascular and metabolic health, and psychosocial wellbeing. Results from this pilot will inform the methods of the main Physical and Affective Wellbeing Study of dog owners (PAWS) trial that will be internationally the first controlled trial to examine the health effect of “real world” dog ownership.

Study Design:

We are employing a complex semi-randomised design – a hybrid of experimental (randomised controlled trial) and quasi-experimental (pre-post) designs- that will potentially allow swift recruitment and participant retention in the study even in the event of change of circumstances with regards to dog ownership.

The study population consists of community members who are considering or planning to acquire a dog but have not found one yet. Eligible participants will be allocated to one of three study arms. Due to the complex nature of the exposure tested (living with a dog) and the inherent difficulties with randomisation in this study’s context, the research design has been customised to maximise participant recruitment rate and increase the likelihood of participant retention in the study.

Two pools of participants will be screened for eligibility and undergo baseline measurements. Those interested in dog ownership (Pool 1) are subdivided into two sub-groups (Pool 1a and Pool 1b) which differ by timing of pet ownership commencement. Participants in Pool 1a will acquire their dogs one month after baseline health measurements are taken. Pool 1b consists of participants who are interested in adopting a dog at any point after 8 months has elapsed since their baseline health measurements were taken. (Pool 2 (Community Controls) comprises age and gender-matched participants who are uninterested in pet ownership. All participants undergo mid- and end of study measurements.

Pool 1 participants will be given the option to be randomised to Pool 1a or 1b; or to a fixed allocation to Pool 1a or 1b. By affording participants this choice, the study maximizes participation and accelerates recruitment rate by offering flexibility to suit participants’ circumstances. At analysis, this may also afford a time-lapsed control group (Pool 1b) among randomized participants. To maximise participant retention in the study and to use already collected baseline data, the design will allow transfer within Pool 1 (from to Pool 1a to Pool 1b or vice versa) for those participants whose intended dog-ownership timeline changes within a period of 3 months from baseline measurement (although this will be discouraged at study enrolment and incentives to adhere to the originally allocated group will be provided). Participants who wish to switch Pool after 3 months from baseline measurements will be considered drop-outs and will be withdrawn from the study.

Procedures:

Participants will have four contact points: initial contact (recruitment/screening) and then baseline, mid-term and final measurements.

Contact point 1 may happen remotely, as in the case for recruitment via social media, or may be face-to-face, as in the case for a focused event; screening can be offered online or at a face-to-face contact. Contact points 2-4 involve face to face meetings for the administration of wearable monitors and biological samples which will take place at the Charles Perkins Centre, a partner animal shelter, or the participants’ residence; participants will determine the location. The face to face meeting is followed by a telephone call after 6-8 days to administer the study questionnaire and request participant to return the monitors by reply-paid post.

For each participant, contact point 2 will be the baseline; contact point 3 will occur at the 3 month mark and contact point 4 will occur at the 8 month point (study end).

Participant incentives:

Incentives will offered to participants upon study completion as outlined in “PAWS Incentive Grading Protocol”. Community controls (Pool 2) will be offered $150 as compensation for the time dedicated in the study.

Pool 1 participants will be offered non-monetary incentives comprising supply of routine dog medication (basic vaccinations, internal and external parasite protection) and one or two vet appointments for a routine check-ups and administration of the vaccination.

Pool 1 participants who agree to be randomised and adhere to the allocated group until study completion will be offered a higher amount of routine vet medication. Participants who skip the mid-term measurements but complete the baseline and 8-month measurements will be offered reduced incentives to reflect the lower time commitment.

Intervention code [1] 298487 0
Lifestyle
Comparator / control treatment
One control group consists of people uninterested in dog ownership.

There is also a time-delayed control group (Pool 1b) consisting of individuals interested in dog ownership who have been randomized to the waitlist arm. Participants in this pool will have expressed interest in acquiring a dog at any point after 8 months has elapsed since their baseline health measurements were taken.
Control group
Active

Outcomes
Primary outcome [1] 302517 0
Changes in human physical activity and sedentary behavior patterns (as measured by ActivPAL activity and responses to the PAWS master questionnaire) will be measured as a composite primary outcome.

The PAWS master questionnaire is a combination of various validated questionnaires regularly used in the literature (see the Positive and Negative Affect Schedule (PANAS), UCLA Loneliness Scale, Kessler10, and Monash Dog Owner Relationship Scale (MDORS) questionnaires). The PAWS master questionnaire has been tailored specifically for this study.
Timepoint [1] 302517 0
3 months and 8 months after baseline measurements
Primary outcome [2] 302518 0
Changes in human psychosocial wellbeing (as measured by responses to the PAWS master questionnaire) will be measured as a composite primary outcome.

The PAWS master questionnaire is a combination of various validated questionnaires regularly used in the literature (see the Positive and Negative Affect Schedule (PANAS), UCLA Loneliness Scale, Kessler10, and Monash Dog Owner Relationship Scale (MDORS) questionnaires).

Timepoint [2] 302518 0
3 months and 8 months after baseline measurements
Primary outcome [3] 302519 0
Changes in cardiovascular health (as measured by changes in performance on the step test and blood pressure readings) will be measured as a primary outcome.
Timepoint [3] 302519 0
3 months and 8 months after baseline measurements
Secondary outcome [1] 336281 0
Feasibility of the recruitment mechanism will be assessed as a secondary outcome of the study. Specifically, we will be testing the feasibility of recruiting participants through an online survey advertised on PetRescue.com.au. The survey has also been advertised through various other media outlets (e.g. social media, radio, and television).

Timepoint [1] 336281 0
8 months after baseline measurements
Secondary outcome [2] 336460 0
Participant group allocation will be assessed as a secondary outcome of the study. We will investigate how allowing participants flexibility in terms of when they acquire their dog affects participant retention rates..
Timepoint [2] 336460 0
8 months after baseline measurements
Secondary outcome [3] 336462 0
The feasibility of the study's measurement methods will be assessed as a secondary outcome of the study. Measurement methods include examining salivary cortisol and oxytocin levels in participants, taking blood pressure readings, observing step test performance, taking height and weight measurements, administering a customized PAWS master questionnaire, using an ActivPAL device to monitor human physical activity, and providing participants with a sleep diary.
Timepoint [3] 336462 0
8 months after baseline measurements
Secondary outcome [4] 336630 0
Changes in metabolic health (as measured by changes in oxytocin, cortisol, and blood glucose levels)
Timepoint [4] 336630 0
3 months and 8 months after baseline measurements

Eligibility
Key inclusion criteria
Inclusion criteria – human participants
1. (Pool 1 participants: prospective dog owners) Considering to acquire (adopt or buy) one dog imminently or in the future; intending to be the main/joint/only carer of the dog; not having owned a dog for at least one year prior to study enrolment
2. (Pool 2 participants: community controls) Never having owned a dog as primary/sole/joint carer in the past and not considering to adopt or buy a dog in the future
3. Not currently owning another pet (cat or other furry animal)
4. Not planning to acquire another pet (i.e., more than one dog or a different furry animal)for the duration of the study
5. Aged 18 and over
6. Reside in NSW
7. Fluent in English
8. Absence of physical limitations that prevent walking
9. No history of having surrendered a dog in the last 3 years

Inclusion criteria – dog (for Pool 1 participants who will acquire a dog during the study)
• No veterinary conditions that would limit low intensity activities such as walking.
• Not a puppy (6 months old or less)
• Not having entered the last quintile of expected lifespan for the given breed
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Human exclusion criteria:
-Under 18
-Live outside of the Sydney metropolitan area
-Have physical limitations that prevent walking
-Owned or cared for a dog for more than 6 months within the last year
-Currently own a furry pet
-Will acquire another furry pet during the study

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Each participant will be given a unique and de-identified participant ID, which will link multiple measures within individuals. The pilot study will be analysed for monthly rate of recruitment, rates of participants the randomised and fixed allocation parts of the study, rates of Pool 1 participants requesting to switch study arms, completion rates for each measurement/arm of the study, drop-out rates for each stud condition/Pool and participant acceptability of the study design and measurement protocols.

In terms of the secondary aims of the project, a repeated-measure Multivariate Analysis of Variance (MANOVA) will be used test the effects of experimental condition by time within individual. Analyses will be performed both on an intention-to-treat and a protocol basis. In the intention-to-treat analyses each participant will be analysed in the Pool that was originally allocated (for example participants who were allocated in Pool 1a will be analysed as such even if they moved to Pool 1b six weeks past the baseline measurements). In the protocol-based analysis each Pool 1 participant will be analysed according to the Pool where the completed the study. Length of dog ownership will be entered as a covariate in all analyses examining the effect of dog ownership on health outcomes.

Other secondary analyses will include computations of Spearman correlation coefficients between the dog walking questionnaire and the Heyrex dog activity monitor outputs as an indication of the comparative and convergent validity of the dog walking questions we developed; and Spearman correlation coefficients between the Dog Logbook frequency of certain dog behavioural issues and the output of the Canine Behavioral Assessment & Research Questionnaire to estimate comparative validity of the Dog Logbook output.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
4/04/2017
Date of last participant enrolment
Anticipated
Actual
12/09/2018
Date of last data collection
Anticipated
20/06/2019
Actual
Sample size
Target
100
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 296807 0
Other
Name [1] 296807 0
Anonymous Philanthropist
Country [1] 296807 0
Australia
Funding source category [2] 296859 0
Commercial sector/Industry
Name [2] 296859 0
Animal Medicines Australia
Country [2] 296859 0
Australia
Primary sponsor type
Individual
Name
Dr. Emmanuel Stamatakis
Address
Prevention Research Collaboration
L6 West, Hub D17
Charles Perkins Centre
The University of Sydney
Camperdown, NSW
2006
Country
Australia
Secondary sponsor category [1] 295793 0
University
Name [1] 295793 0
University of Sydney
Address [1] 295793 0
Charles Perkins Centre
The University of Sydney
Camperdown, NSW
2006
Country [1] 295793 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298040 0
Human Research Ethics Committee of the University of Sydney
Ethics committee address [1] 298040 0
Ethics committee country [1] 298040 0
Australia
Date submitted for ethics approval [1] 298040 0
31/10/2016
Approval date [1] 298040 0
16/02/2017
Ethics approval number [1] 298040 0
2016/921
Ethics committee name [2] 298041 0
Animal Ethics Committee of the University of Sydney
Ethics committee address [2] 298041 0
Ethics committee country [2] 298041 0
Australia
Date submitted for ethics approval [2] 298041 0
18/01/2017
Approval date [2] 298041 0
24/02/2017
Ethics approval number [2] 298041 0
2017/1164

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1822 1822 0 0
/AnzctrAttachments/373183-Animal Ethics Approval Letter.pdf (Ethics approval)
Attachments [2] 1823 1823 0 0
/AnzctrAttachments/373183-Human Ethics Approval Letter.pdf (Ethics approval)
Attachments [3] 1824 1824 0 0
/AnzctrAttachments/373183-PAWS Participant Information and Consent.pdf (Participant information/consent)

Contacts
Principal investigator
Name 75790 0
Dr Emmanuel Stamatakis
Address 75790 0
Prevention Research Collaboration
L6 West, Hub D17
Charles Perkins Centre
The University of Sydney
Camperdown, NSW
2006
Country 75790 0
Australia
Phone 75790 0
+61 2 86271867
Fax 75790 0
Email 75790 0
emmanuel.stamatakis@sydney.edu.au
Contact person for public queries
Name 75791 0
Debbie Chia
Address 75791 0
Prevention Research Collaboration
L6 West, Hub D17
Charles Perkins Centre
The University of Sydney
Camperdown, NSW
2006
Country 75791 0
Australia
Phone 75791 0
+61 2 8627 5791
Fax 75791 0
Email 75791 0
cpc.dognode@sydney.edu.au
Contact person for scientific queries
Name 75792 0
Emmanuel Stamatakis
Address 75792 0
Prevention Research Collaboration
L6 West, Hub D17
Charles Perkins Centre
The University of Sydney
Camperdown, NSW
2006
Country 75792 0
Australia
Phone 75792 0
+61 2 8627 5791
Fax 75792 0
Email 75792 0
emmanuel.stamatakis@sydney.edu.au

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