Physical and Affective Wellbeing Study of dog owners (PAWS)

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.