Clinical trial NCT04400305: "Increasing Physical Activity in Canadian Adults Affected by COVID-19 Social Distancing Restrictions: A Feasibility Trial of an Online Intervention"
Official title: "Increasing Physical Activity in Canadian Adults Who Have Been Affected by COVID-19 Social Distancing Restrictions: A Feasibility Trial of an Online Intervention"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity, Healthy Promotion
Lead sponsor: University of Victoria
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: OTHER

Brief summary: Internet-based health promotion programs have the potential to reach more individuals than in person interventions, without overtaxing healthcare resources. Having a high quality, user-centered web-based program can help maximize user engagement and adherence. Thus, the primary objective of this pilot study is to examine the feasibility, time, cost, and acceptability of a web-based physical activity behavior change program with Canadian Adults who have had to start practising/following the social distancing guidelines due to the COVID-19 situation. We will also be examining changes other behavioral indicators related to PA as a secondary outcome measure.

Detailed description: Background: Physical activity is associated with management and/or prevention of over 25 chronic health conditions; however the majority of adults in North America are not active enough to experience these benefits. Behavioral strategies have been shown to be effective for increasing physical activity, and our online platform includes components of several behavioral strategies including goal setting and feedback.

Target Population: Participants will be Canadian adults over 18 who have

1. recently started practising social distancing due to our current COVID-19 situation
2. currently are participating in physical activity below Canadian recommended guidelines (150 minutes of moderate to vigorous activity per week).
3. Participants must have access to the Internet. Sample Size: 40 participants, 20 participants per group - (Control) 20 participants (intervention) Participants will be excluded from the project if they do not have access to the Internet, are unable to speak/read English, are not engaging in moderate-to vigorous PA (MVPA) sufficient to meet the PA Guidelines, have an existing chronic medical condition potentially making them at risk of injury or ill health from increasing their physical activity (assessed using the GAQ. Screening will be completed formally over the phone, and participants will give their consent online.

Condition one: Waitlist control group: One group (evenly representing Adults practising social distancing) will complete the baseline and final questionnaires (online). At the end of the study this group will have the option to receive access to the other group's materials (online platform) if they wish, for the 6 week period following the study. Access to the online platform is for study participant use and benefit only and no participant data/website analytics will be collected at this point in the study.

Condition two: One group (evenly representing Adults practising social distancing) will complete the online baseline questionnaire, and receive access to the online platform. Briefly, the participants will be shown (via skype, Face time, Zoom or other alternate online technology) how to use it .

At 3 weeks, a check-in session will occur, depending on what the participant prefers, a researcher will arrange a virtual visit or phone call with the participant to chat about how their physical activity has been going and to ensure the web application' usability. Again at this point on-going consent will be secured. At 6 weeks a researcher will arrange a virtual visit or phone call with the participant \& ask them to complete the final online questionnaire and do a wrap up interview. The end-of-trial qualitative interview will evaluate participant satisfaction and feasibility of the intervention. For this reason a lab employee unaffiliated with this study will complete these interviews via skype or alternate technology. The interview will be audio-recorded transcribed verbatim. After the intervention group participants have completed the 6 week online program, data collection will be complete and while they may still access the platform for an additional 6 weeks, data collection from participants or website use analytics will not be ongoing.

Eligibility criteria: Inclusion Criteria:

Potential participants will be included if they have:

1. started practising social distancing due to the current COVID-19 guidelines
2. are currently not meeting the physical activity (PA) guidelines (less than 150 minutes of moderate to vigorous aerobic activity)
3. participants must have access to the internet at home, and have a smart phone or home computer that can support the eHealth application we are using.

Exclusion Criteria:

Participants will be excluded from the project if:

1. they do not have access to the Internet,
2. are unable to speak/read English,
3. are engaging in moderate-to vigorous PA (MVPA) sufficient to meet the PA Guidelines,
4. have an existing chronic medical condition potentially making them at risk of injury or ill health from increasing their physical activity (this will be assessed using the GAQ. Screening completed formally over the phone, and participants will give their consent online)

Primary outcomes:
measure: Recruitment rate (monthly)
timeFrame: 4 months
measure: Participant retention
timeFrame: 6 weeks
measure: Participant intervention satisfaction/evaluation
timeFrame: 6 Weeks
Secondary outcomes:
measure: Change in self-reported physical activity from baseline to 6 weeks
timeFrame: 6 Weeks
measure: Change in physical activity beliefs, attitudes, barriers, and motivation from baseline to 6 weeks.
timeFrame: Baseline - 6 weeks
measure: Change in physical activity behaviour regulation from baseline to 6 weeks.
timeFrame: Baseline - 6 weeks
measure: Change in physical activity habits from baseline to 6 weeks
timeFrame: Baseline - 6 weeks
measure: Change in physical activity identity from baseline to 6 weeks
timeFrame: Baseline - 6 weeks
measure: Change in life satisfaction measured using the Short Form 12 questionnaire from baseline to 6 weeks
timeFrame: Baseline - 6 weeks
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Behavioural Medicine Lab, University of Victoria
state: British Columbia
city: Victoria
country: Canada
facility: University of Victoria
state: British Columbia
Study officials:
References:
citation: Jackson N, Waters E; Guidelines for Systematic Reviews in Health Promotion and Public Health Taskforce. Criteria for the systematic review of health promotion and public health interventions. Health Promot Int. 2005 Dec;20(4):367-74. doi: 10.1093/heapro/dai022. Epub 2005 Sep 16.