Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001391167
Ethics application status
Approved
Date submitted
3/09/2019
Date registered
10/10/2019
Date last updated
10/10/2019
Date data sharing statement initially provided
10/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Increasing dog-walking in the community: what is the potential of wearable dog trackers? The PAWalks trial
Scientific title
Increasing dog-walking in the community: what is the potential of wearable dog trackers? The PAWalks trial
Secondary ID [1] 298762 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 314257 0
Condition category
Condition code
Public Health 312613 312613 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will be provided with;
- Dog-walking education materials, two phone calls; one at the beginning and one at the end of the 3-month intervention period, weekly text messages and a dog activity tracker device (G-FitEdu, n=40).
- The dog-walking educational materials have been specifically designed for this study, and are based on multi-process action control and nascent dog-walking theory (goal-setting/coping strategies/behaviour monitoring).
- The purpose of the initial phone call (5-10min) is to discuss the contents of the educational materials, ensure that the Fitbark 2 has been set-up properly (G-FitEdu group only) and create a dog-walking goal for the following 12 weeks.
- The purpose of the second phone call (5 min) is to discuss progress towards the goal, and encourage continued use of the Fitbark 2 (G-FitEdu group only).
- The purpose of the weekly text messages is to prompt participants for dog walking.
- The intervention will be delivered by a trained research officer by email and phone.
- One text message will be sent each week during the 3-month intervention period, totalling 12 text messages.
- Participants will receive and complete the intervention within their usual place of occupancy, ie. their home/community.
- To ensure adherence and fidelity, the researcher will ask questions about the participants use of the educational materials and dog tracker during the 3-month intervention period in the second phone call at the close of the intervention.
Intervention code [1] 315461 0
Behaviour
Comparator / control treatment
Participants in the control group will be provided with;
- Dog-walking education materials and two phone calls; one at the beginning and one at the end of the 3-month intervention period. (G-Edu, n=40).
Control group
Active

Outcomes
Primary outcome [1] 321262 0
Participants daily number of steps - as measured by an ActivPAL Micro device worn on the thigh for 7 days at 0 months (baseline), 7 days after 3 months (post-intervention) and 7 days after 6 months (follow-up).
Timepoint [1] 321262 0
0 months (baseline), 3 months (post-intervention - primary timepoint), 6 months (follow-up) from intervention.
Secondary outcome [1] 374477 0
sedentary behaviour time - as measured in self-reported questionnaire: adapted from 'The Active Australia Survey' by Australian Institute of Health & Welfare..
Timepoint [1] 374477 0
0 months (baseline), 3 months (post-intervention), 6 months (follow-up) from intervention.
Secondary outcome [2] 374760 0
psychological distress - as measured by self-reported questionnaire; Kessler10.
Timepoint [2] 374760 0
0 months (baseline), 3 months (post-intervention), 6 months (follow-up) from intervention.
Secondary outcome [3] 374761 0
loneliness - as measured in self-reported questionnaire; UCLA Loneliness Scale.
Timepoint [3] 374761 0
0 months (baseline), 3 months (post-intervention), 6 months (follow-up) from intervention.
Secondary outcome [4] 374762 0
positive affect - as measured in self-reported questionnaire; Positive and Negative Affect Schedule (PANAS).
Timepoint [4] 374762 0
0 months (baseline), 3 months (post-intervention), 6 months (follow-up) from intervention.
Secondary outcome [5] 374763 0
dog-ownership attributed social connections - as measured by self-reported questionnaires: adapted from 'The Pet Factor - Companion Animals as a Conduit for Getting to Know People, Friendship Formation and Social Support' by Wood et al, 2015.
Timepoint [5] 374763 0
0 months (baseline), 3 months (post-intervention), 6 months (follow-up) from intervention.
Secondary outcome [6] 374764 0
dog-owner relationship - as measured in self-reported questionnaire; Monash Dog Owner Relationship Scale (MDORS).
Timepoint [6] 374764 0
0 months (baseline), 3 months (post-intervention), 6 months (follow-up) from intervention.

Eligibility
Key inclusion criteria
• Aged 18 and over
• Currently the owner of one dog that:
o Has no veterinary conditions that would limit low intensity activities such as walking.
o Has not entered the last decile of expected lifespan for the given breed
o Is not less than 1 year old (not a puppy)
• Absence of physical limitations that prevent walking
• Residing within the Sydney Metropolitan Area (within 60km of the Sydney CBD)
• Not pregnant or planning to become pregnant during the trial
• Able to fluently speak and understand English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Does not own a dog, or owns more than one dog.
• Physical limitations that prevent walking
• Pregnant or planning to become pregnant during the trial
• Has previously or currently used a FitBark device or similar dog physical activity
tracker device.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled 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)
Participants are randomised into one of two study arms (G-FitEdu or G-Edu). To randomise participants, researchers will use www.randomization.com. This website application uses randomly permuted blocks as a method for randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Prior to randomisation, participants will not be informed of the exact details of either intervention but will be given a general description of the components that may be involved. This is to try and keep both groups naïve to the alternative intervention. Using a “naivety” approach will help to reduce G-Edu dropouts (if participants know that they were not allocated the Fitbark 2, they may be disappointed and drop out) and to prevent G-Edu participants contaminating results by purchasing their own Fitbark 2 or another dog-tracker.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of n=37 per group will be needed to detect a significant difference between the two dog walking intervention groups in change in number of daily steps (taken by humans) from baseline to 9 months (a=.05, ß=.80, effect size d=0.58 calculated using baseline to 12 months changes in daily steps from a pilot intervention18: +501 steps/d among controls (change SD =2008) vs. +2330 steps/d in the intervention (change SD=4193) groups). A pooled n=59 for the two groups will be needed to detect significant differences in daily steps changes over time between interventions and controls (allocation ratio 1:1, a, ß, d as above). We propose to recruit 40 participants per group to allow for a 10% drop out rate. We will use t-tests to assess differences in changes in primary and secondary outcomes between the two intervention groups. Mixed linear models will be used to assess intervention effects across the 2 groups, with baseline values of the dependent variables used as covariates. To examine if changes in physical activity variables over the course of the trial influenced the psychosocial outcomes and other secondary outcomes we will develop linear mixed models using PAWalks arm, time point, change of walking levels, and their interactions. Whenever possible, analyses will be adjusted for differences in canine characteristics between groups (breed, size, etc.). All analyses will be performed using intention-to-treat and per-protocol approaches.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/05/2019
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/07/2020
Actual
Sample size
Target
80
Accrual to date
37
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303317 0
Charities/Societies/Foundations
Name [1] 303317 0
Human Animal Bond Research Institute (HABRI)
Country [1] 303317 0
United States of America
Primary sponsor type
University
Name
The University of Sydney
Address
Prevention Research Collaboration
Charles Perkins Centre (D17)
The University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 303824 0
None
Name [1] 303824 0
Address [1] 303824 0
Country [1] 303824 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303851 0
The University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 303851 0
Ethics committee country [1] 303851 0
Australia
Date submitted for ethics approval [1] 303851 0
29/10/2018
Approval date [1] 303851 0
26/02/2019
Ethics approval number [1] 303851 0
2018/1000

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

Contacts
Principal investigator
Name 95022 0
Prof Emmanuel Stamatakis
Address 95022 0
Prevention Research Collaboration
Charles Perkins Centre
L6 West, Hub 617
The University of Sydney, NSW 2006
Country 95022 0
Australia
Phone 95022 0
+61 02 8627 7298
Fax 95022 0
Email 95022 0
[email protected]
Contact person for public queries
Name 95023 0
Emily Duve
Address 95023 0
Prevention Research Collaboration
Charles Perkins Centre
L6 West, 6W64
The University of Sydney, NSW 2006
Country 95023 0
Australia
Phone 95023 0
+61 02 8627 7298
Fax 95023 0
Email 95023 0
[email protected]
Contact person for scientific queries
Name 95024 0
Emmanuel Stamatakis
Address 95024 0
Prevention Research Collaboration
Charles Perkins Centre
L6 West, Hub 617
The University of Sydney, NSW 2006
Country 95024 0
Australia
Phone 95024 0
+61 02 8627 7298
Fax 95024 0
Email 95024 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.