Physical Activity, Healthy PromotionCOVID-19NCT04400305
"Increasing Physical Activity in Canadian Adults Affected by COVID-19 Social Distancing Restrictions: A Feasibility Trial of an Online Intervention"
A study testing Digital Health Online Platform in people with Physical Activity, Healthy Promotion, run by University of Victoria at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Healthy Promotion
- What is being tested?
- Digital Health Online Platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesCanada
- Study dates
- 20 May 2020to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Potential participants will be included if they have:
- started practising social distancing due to the current COVID-19 guidelines
- are currently not meeting the physical activity (PA) guidelines (less than 150 minutes of moderate to vigorous aerobic activity)
- 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.
Who cannot join
- Participants will be excluded from the project if:
- they do not have access to the Internet,
- are unable to speak/read English,
- are 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 (this will be assessed using the GAQ. Screening completed formally over the phone, and participants will give their consent online)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Behavioural Medicine Lab, University of Victoria
Victoria, British Columbia, V8P-5C2
University of Victoria
Victoria, British Columbia, V8W 2Y2
About this study
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"
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.
Read the 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
- recently started practising social distancing due to our current COVID-19 situation
- currently are participating in physical activity below Canadian recommended guidelines (150 minutes of moderate to vigorous activity per week).
- 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.
- Conditions
- Physical Activity, Healthy Promotion
- Being tested
- Digital Health Online Platform
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health Online PlatformBehavioural
The website has 10 lessons that the participant will gain access to on a bi-weekly basis. Lesson titles are as follows:
Lesson 1 - Benefits of Physical Activity on Chronic Disease Lesson 2 - Mental benefits of Physical Activities Lesson 3 - Increasing Self Confidence for Physical Activities Lesson 4 - Learning about your Emotions Lesson 5 - Building Social Support Lesson 6 - Building Physical Activity Opportunity Lesson 7 - Goal Setting and Planning Lesson 8 - Self Monitoring Lesson 9 - Habit Lesson 10 - Identity
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No Intervention: Control Group This group will complete 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. |
| Intervention | Other | Participants will complete a baseline questionnaire, and receive access to the our online platform for 6 weeks. Completing the online platform is designed to encourage participants to engage in physical activity. At 3 weeks, a check-in session will occur over the phone. At 6 weeks the participant will be contacted to complete the final 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 in person interviews. Receives: Behavioral: Digital Health Online Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate (monthly)
For the full scale RCT, we are looking for a 1 day per week or 30 min MVPA change which equates to an approximate effect size of d = .35. This equates to roughly 65 per group (130 for a two group trial). If we recruit for 2 years in the large trial (assuming a six month time period for each person in the intervention) we need to be recruiting at least 6 per month.
Measured: 4 months
Participant retention
Number of participants who complete both baseline and end of study (6 week) measures. A 80-100% retention rate is indicative of a strong trial (Jackson \& Waters, 2005).
Measured: 6 weeks
Participant intervention satisfaction/evaluation
For satisfaction ratings, mean and standard deviations will be calculated for the quantitative satisfaction and evaluation questionnaire. Given that scores of 1 (ex. not helpful, did not use the tools) and 2 (ex. Somewhat helpful, used a little bit of the tools) indicated levels of dissatisfaction, and 3 (ex. Quite helpful, used a bit of the tools) and 4 (ex. Extremely helpful, used a lot of the tools) indicated some sort of satisfaction, a mean score of ≥ 2.5 will be deemed acceptable for recommendation for a full RCT.
Measured: 6 Weeks
Secondary outcomes (6)
Change in self-reported physical activity from baseline to 6 weeks
Measured from questionnaire using Godin's personal self report leisure time measurement tool, also known as the Leisure Score Index (LSI). The Leisure Score Index contains three questions, which assess the frequency of mild, moderate, and strenuous activity performed for at least 10 minutes during free time in a typical week. Changes in these measures will be examined
Measured: 6 Weeks
Change in physical activity beliefs, attitudes, barriers, and motivation from baseline to 6 weeks.
Included in questionnaire - Ajzen's theory of planned behaviour questionnaire will be applied to measure participants' beliefs, attitudes, barriers, and motivation related to physical activity.
Measured: Baseline - 6 weeks
Change in physical activity behaviour regulation from baseline to 6 weeks.
Included in questionnaire - 5 items adapted from Umstattd's scale measuring physical activity self-regulation strategies. Changes in this measure will be examined. The Behavioural Regulation in Exercise Questionnaire - 5 point Likert Scale 1 = Strongly agree to 5 = Strongly Disagree
Measured: Baseline - 6 weeks
Change in physical activity habits from baseline to 6 weeks
Included in questionnaire - 12 Self Report Habit Index items from the measure developed by Verplanken and Orbell and adapted to physical activity by Chatzisarantis and Hagger. Changes in this measure will be examined. Physical Activity Participation Habits Questionnaire - Habit Index - 5 point Likert Scale 1 = Strongly agree to 5 = Strongly Disagree
Measured: Baseline - 6 weeks
Change in physical activity identity from baseline to 6 weeks
Included in questionnaire - Anderson and Cychosz Exercise Identity Scale is used to measure participants' identification as someone who participates in physical activity. Physical Activity Participation Identity Questionnaire - Identity Scale - 5 point Likert Scale 1 = Strongly agree to 5 = Strongly Disagree
Measured: Baseline - 6 weeks
Change in life satisfaction measured using the Short Form 12 questionnaire from baseline to 6 weeks
Change in life satisfaction from baseline to 6 weeks measured using Diener's satisfaction with life scale in a questionnaire.
The online questionnaire will asses participants' life satisfaction using Diener's satisfaction with life scale. Changes in this measure will be examined (6 weeks to baseline) [Time Frame: Baseline to 6 weeks] Variable scale.
Measured: Baseline - 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start20 May 2020
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical Activity, Healthy PromotionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Victoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Rhodes, University of Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400305
- Sponsor's protocol ID
- 05-281983
- Acronym
- COVID-19
- Status last verified
- Oct 2021
- First submitted
- 21 May 2020
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16169885
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT04400305
- Acronym / sponsor ID
- COVID-19 / 05-281983
- Conditions
- Physical Activity, Healthy Promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- recently started practising social distancing due to our current COVID-19 situation
- currently are participating in physical activity below Canadian recommended guidelines (150 minutes of moderate to vigorous activity per week).
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No Intervention: Control Group This group will complete 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. |
| Intervention | Other | Behavioral: Digital Health Online PlatformParticipants will complete a baseline questionnaire, and receive access to the our online platform for 6 weeks. Completing the online platform is designed to encourage participants to engage in physical activity. At 3 weeks, a check-in session will occur over the phone. At 6 weeks the participant will be contacted to complete the final 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 in person interviews. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- started practising social distancing due to the current COVID-19 guidelines
- are currently not meeting the physical activity (PA) guidelines (less than 150 minutes of moderate to vigorous aerobic activity)
- 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.
Key exclusion criteria (5 listed)
- they do not have access to the Internet,
- are unable to speak/read English,
- are 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 (this will be assessed using the GAQ. Screening completed formally over the phone, and participants will give their consent online)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Health Online PlatformThe website has 10 lessons that the participant will gain access to on a bi-weekly basis. Lesson titles are as follows: Lesson 1 - Benefits of Physical Activity on Chronic Disease Lesson 2 - Mental benefits of Physical Activities Lesson 3 - Increasing Self Confidence for Physical Activities Lesson 4 - Learning about your Emotions Lesson 5 - Building Social Support Lesson 6 - Building Physical Activity Opportunity Lesson 7 - Goal Setting and Planning Lesson 8 - Self Monitoring Lesson 9 - Habit Lesson 10 - Identity | Behavioural | Intervention |
Primary outcome
Recruitment rate (monthly)
Time frame: 4 months
For the full scale RCT, we are looking for a 1 day per week or 30 min MVPA change which equates to an approximate effect size of d = .35. This equates to roughly 65 per group (130 for a two group trial). If we recruit for 2 years in the large trial (assuming a six month time period for each person in the intervention) we need to be recruiting at least 6 per month.
Participant retention
Time frame: 6 weeks
Number of participants who complete both baseline and end of study (6 week) measures. A 80-100% retention rate is indicative of a strong trial (Jackson \& Waters, 2005).
Participant intervention satisfaction/evaluation
Time frame: 6 Weeks
For satisfaction ratings, mean and standard deviations will be calculated for the quantitative satisfaction and evaluation questionnaire. Given that scores of 1 (ex. not helpful, did not use the tools) and 2 (ex. Somewhat helpful, used a little bit of the tools) indicated levels of dissatisfaction, and 3 (ex. Quite helpful, used a bit of the tools) and 4 (ex. Extremely helpful, used a lot of the tools) indicated some sort of satisfaction, a mean score of ≥ 2.5 will be deemed acceptable for recommendation for a full RCT.
6 secondary outcomes
Change in self-reported physical activity from baseline to 6 weeks
Time frame: 6 Weeks
Change in physical activity beliefs, attitudes, barriers, and motivation from baseline to 6 weeks.
Time frame: Baseline - 6 weeks
Change in physical activity behaviour regulation from baseline to 6 weeks.
Time frame: Baseline - 6 weeks
Change in physical activity habits from baseline to 6 weeks
Time frame: Baseline - 6 weeks
Change in physical activity identity from baseline to 6 weeks
Time frame: Baseline - 6 weeks
Change in life satisfaction measured using the Short Form 12 questionnaire from baseline to 6 weeks
Time frame: Baseline - 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Background: PubMed 16169885Jackson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health Online Platform in people with Physical Activity, Healthy Promotion, run by University of Victoria at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (monthly) (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04400305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.