<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04400305</url>
  </required_header>
  <id_info>
    <org_study_id>05-281983</org_study_id>
    <nct_id>NCT04400305</nct_id>
  </id_info>
  <brief_title>&quot;Increasing Physical Activity in Canadian Adults Affected by COVID-19 Social Distancing Restrictions: A Feasibility Trial of an Online Intervention&quot;</brief_title>
  <acronym>COVID-19</acronym>
  <official_title>&quot;Increasing Physical Activity in Canadian Adults Who Have Been Affected by COVID-19 Social Distancing Restrictions: A Feasibility Trial of an Online Intervention&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Victoria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Victoria</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Internet-based health promotion programs have the potential to reach more individuals than in&#xD;
      person interventions, without overtaxing healthcare resources. Having a high quality,&#xD;
      user-centered web-based program can help maximize user engagement and adherence. Thus, the&#xD;
      primary objective of this pilot study is to examine the feasibility, time, cost, and&#xD;
      acceptability of a web-based physical activity behavior change program with Canadian Adults&#xD;
      who have had to start practising/following the social distancing guidelines due to the&#xD;
      COVID-19 situation. We will also be examining changes other behavioral indicators related to&#xD;
      PA as a secondary outcome measure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Physical activity is associated with management and/or prevention of over 25&#xD;
      chronic health conditions; however the majority of adults in North America are not active&#xD;
      enough to experience these benefits. Behavioral strategies have been shown to be effective&#xD;
      for increasing physical activity, and our online platform includes components of several&#xD;
      behavioral strategies including goal setting and feedback.&#xD;
&#xD;
      Target Population: Participants will be Canadian adults over 18 who have&#xD;
&#xD;
        1. recently started practising social distancing due to our current COVID-19 situation&#xD;
&#xD;
        2. currently are participating in physical activity below Canadian recommended guidelines&#xD;
           (150 minutes of moderate to vigorous activity per week).&#xD;
&#xD;
        3. Participants must have access to the Internet. Sample Size: 40 participants, 20&#xD;
           participants per group - (Control) 20 participants (intervention) Participants will be&#xD;
           excluded from the project if they do not have access to the Internet, are unable to&#xD;
           speak/read English, are not engaging in moderate-to vigorous PA (MVPA) sufficient to&#xD;
           meet the PA Guidelines, have an existing chronic medical condition potentially making&#xD;
           them at risk of injury or ill health from increasing their physical activity (assessed&#xD;
           using the GAQ. Screening will be completed formally over the phone, and participants&#xD;
           will give their consent online.&#xD;
&#xD;
      Condition one: Waitlist control group: One group (evenly representing Adults practising&#xD;
      social distancing) will complete the baseline and final questionnaires (online). At the end&#xD;
      of the study this group will have the option to receive access to the other group's materials&#xD;
      (online platform) if they wish, for the 6 week period following the study. Access to the&#xD;
      online platform is for study participant use and benefit only and no participant data/website&#xD;
      analytics will be collected at this point in the study.&#xD;
&#xD;
      Condition two: One group (evenly representing Adults practising social distancing) will&#xD;
      complete the online baseline questionnaire, and receive access to the online platform.&#xD;
      Briefly, the participants will be shown (via skype, Face time, Zoom or other alternate online&#xD;
      technology) how to use it .&#xD;
&#xD;
      At 3 weeks, a check-in session will occur, depending on what the participant prefers, a&#xD;
      researcher will arrange a virtual visit or phone call with the participant to chat about how&#xD;
      their physical activity has been going and to ensure the web application' usability. Again at&#xD;
      this point on-going consent will be secured. At 6 weeks a researcher will arrange a virtual&#xD;
      visit or phone call with the participant &amp; ask them to complete the final online&#xD;
      questionnaire and do a wrap up interview. The end-of-trial qualitative interview will&#xD;
      evaluate participant satisfaction and feasibility of the intervention. For this reason a lab&#xD;
      employee unaffiliated with this study will complete these interviews via skype or alternate&#xD;
      technology. The interview will be audio-recorded transcribed verbatim. After the intervention&#xD;
      group participants have completed the 6 week online program, data collection will be complete&#xD;
      and while they may still access the platform for an additional 6 weeks, data collection from&#xD;
      participants or website use analytics will not be ongoing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Actual">August 30, 2021</completion_date>
  <primary_completion_date type="Actual">August 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel Assignment</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment rate (monthly)</measure>
    <time_frame>4 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant retention</measure>
    <time_frame>6 weeks</time_frame>
    <description>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 &amp; Waters, 2005).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant intervention satisfaction/evaluation</measure>
    <time_frame>6 Weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported physical activity from baseline to 6 weeks</measure>
    <time_frame>6 Weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity beliefs, attitudes, barriers, and motivation from baseline to 6 weeks.</measure>
    <time_frame>Baseline - 6 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity behaviour regulation from baseline to 6 weeks.</measure>
    <time_frame>Baseline - 6 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity habits from baseline to 6 weeks</measure>
    <time_frame>Baseline - 6 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity identity from baseline to 6 weeks</measure>
    <time_frame>Baseline - 6 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in life satisfaction measured using the Short Form 12 questionnaire from baseline to 6 weeks</measure>
    <time_frame>Baseline - 6 weeks</time_frame>
    <description>Change in life satisfaction from baseline to 6 weeks measured using Diener's satisfaction with life scale in a questionnaire.&#xD;
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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Physical Activity, Healthy Promotion</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Digital Health Online Platform</intervention_name>
    <description>The website has 10 lessons that the participant will gain access to on a bi-weekly basis. Lesson titles are as follows:&#xD;
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</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Potential participants will be included if they have:&#xD;
&#xD;
          1. started practising social distancing due to the current COVID-19 guidelines&#xD;
&#xD;
          2. are currently not meeting the physical activity (PA) guidelines (less than 150 minutes&#xD;
             of moderate to vigorous aerobic activity)&#xD;
&#xD;
          3. participants must have access to the internet at home, and have a smart phone or home&#xD;
             computer that can support the eHealth application we are using.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants will be excluded from the project if:&#xD;
&#xD;
          1. they do not have access to the Internet,&#xD;
&#xD;
          2. are unable to speak/read English,&#xD;
&#xD;
          3. are engaging in moderate-to vigorous PA (MVPA) sufficient to meet the PA Guidelines,&#xD;
&#xD;
          4. have an existing chronic medical condition potentially making them at risk of injury&#xD;
             or ill health from increasing their physical activity (this will be assessed using the&#xD;
             GAQ. Screening completed formally over the phone, and participants will give their&#xD;
             consent online)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Behavioural Medicine Lab, University of Victoria</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8P-5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Victoria</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8W 2Y2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>16169885</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>October 19, 2021</last_update_submitted>
  <last_update_submitted_qc>October 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Victoria</investigator_affiliation>
    <investigator_full_name>Ryan Rhodes</investigator_full_name>
    <investigator_title>Professor Ryan Rhodes</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04400305
org study id: 05-281983
nct id: NCT04400305
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Recruitment rate (monthly)
time frame: 4 months
description: 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.
measure: Participant retention
time frame: 6 weeks
description: 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).
measure: Participant intervention satisfaction/evaluation
time frame: 6 Weeks
description: 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.
measure: Change in self-reported physical activity from baseline to 6 weeks
time frame: 6 Weeks
description: 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
measure: Change in physical activity beliefs, attitudes, barriers, and motivation from baseline to 6 weeks.
time frame: Baseline - 6 weeks
description: 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.
measure: Change in physical activity behaviour regulation from baseline to 6 weeks.
time frame: Baseline - 6 weeks
description: 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
measure: Change in physical activity habits from baseline to 6 weeks
time frame: Baseline - 6 weeks
description: 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
measure: Change in physical activity identity from baseline to 6 weeks
time frame: Baseline - 6 weeks
description: 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
measure: Change in life satisfaction measured using the Short Form 12 questionnaire from baseline to 6 weeks
time frame: Baseline - 6 weeks
description: 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.
arm group label: Control
arm group type: No Intervention
description: 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.
arm group label: Intervention
arm group type: Other
description: 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.
intervention type: Behavioral
intervention name: Digital Health Online Platform
description: 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
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Canada
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.
PMID: 16169885
responsible party type: Principal Investigator
investigator affiliation: University of Victoria
investigator full name: Ryan Rhodes
investigator title: Professor Ryan Rhodes
sharing ipd: No