<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/NCT03248752</url>
  </required_header>
  <id_info>
    <org_study_id>BC17-180</org_study_id>
    <nct_id>NCT03248752</nct_id>
  </id_info>
  <brief_title>Monitoring Physical Activity (Fitbit)</brief_title>
  <official_title>Physical Activity Promotion Through Wearable Monitors: A Test of Self and Partner Monitoring Strategies.</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>
      The purpose of this study is to examine the effect of monitoring and sharing physical&#xD;
      activity outcomes (using Fitbit technology) with a domestic partner on physical activity&#xD;
      participation.&#xD;
&#xD;
      Primary research question: Does sharing physical activity outcomes from wearable technology&#xD;
      with a participant's partner improve overall physical activity over 3 months compared to not&#xD;
      sharing outcomes? Physical activity will be measured as minutes of moderate to vigorous&#xD;
      physical activity per week.&#xD;
&#xD;
      Hypothesis: Knowledge that physical activity outcomes are visible to a participant's partner&#xD;
      will serve as a proxy-supervision intervention. Awareness of partner's progress will serve as&#xD;
      further motivation. Both factors will improve physical activity adherence in comparison to&#xD;
      participants without shared outcomes.&#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 wearable fitness monitors such as Fitbits include&#xD;
      components of several behavioral strategies including goal setting and feedback. While this&#xD;
      technology provides a platform for implementing self-regulation techniques important for&#xD;
      behavior change, direct supervision is still the most effective strategy for behavior change.&#xD;
      Supervised exercise programs and personal trainers may not be accessible or affordable for&#xD;
      people; this study will examine whether proxy supervision by a partner is effective in&#xD;
      changing behavior compared to self-regulation alone.&#xD;
&#xD;
      Target Population: Sedentary adults aged 45-75 years old living in Victoria,&#xD;
      British-Columbia, Canada.&#xD;
&#xD;
      Sample Size: 80 participant pairs (160 total participants), 40 pairs per group (80&#xD;
      participants per group).&#xD;
&#xD;
      Intervention: Participants will be randomized to two groups: 1 - Self Monitored, 2 - Partner&#xD;
      monitored. Both groups will receive an intervention with Group 1 (Self monitored) serving as&#xD;
      the comparison group. Participants from both groups will wear an accelerometer for 1 week and&#xD;
      complete an online questionnaire at baseline, 6 weeks, and 3 months. Measures of height,&#xD;
      weight, waist circumference, and resting blood pressure and heart rate will be taken at&#xD;
      baseline and 3 months. Participants will all receive a Fitbit activity tracker and wear it&#xD;
      for 3 months. Group 2 (Partner monitor) participants will also have access to their partner's&#xD;
      daily progress, receive eachother's Weekly Fitbit reports, and engage in a weekly discussion&#xD;
      related to their Weekly Fitbit Report.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 4, 2017</start_date>
  <completion_date type="Actual">August 26, 2019</completion_date>
  <primary_completion_date type="Actual">August 26, 2019</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in participants' weekly physical activity participation at 3 months.</measure>
    <time_frame>Baseline, 6 weeks, and 3 months</time_frame>
    <description>Quantified as minutes of moderate to vigorous physical activity measured with accelerometry. Participants will wear an accelerometer for a minimum of 10 hours per day for 7 consecutive days. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index from baseline to 3 months.</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Standardized protocols for measuring weight in kilograms (kg) and height in centimeters (cm) will be performed as per the Canadian Society for Exercise Physiology guidelines. Body Mass Index (BMI) will be calculated as kg/m^2. Body Mass Index is an indicator of body composition which is associated with physical activity. Changes in BMI will be examined (3 months to baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference from baseline to 3 months.</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Standardized protocols for measuring waist circumference in centimeters (cm) will be performed as per the Canadian Society for Exercise Physiology guidelines. Waist circumference is an indicator of body composition which is associated with physical activity. Changes in waist circumference will be examined (3 months to baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported physical activity from baseline to 3 months.</measure>
    <time_frame>Baseline, 6 weeks, 3 months.</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 15 minutes during free time in a typical week. Changes in these measures will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life from baseline to 3 months measured using the Short Form 12 questionnaire.</measure>
    <time_frame>Baseline, 6 weeks, 3 months</time_frame>
    <description>The online questionnaire will asses participants' quality of life using the short form 12 questionnaire. Changes in this measures will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in life satisfaction from baseline to 3 months measured using Diener's satisfaction with life scale in a questionnaire.</measure>
    <time_frame>Baseline, 6 weeks, 3 months</time_frame>
    <description>The online questionnaire will asses participants' life satisfaction using Diener's satisfaction with life scale. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mood from baseline to 3 months measured using the Hospital Anxiety and Depression Scale in a questionnaire.</measure>
    <time_frame>Baseline, 6 weeks, 3 months</time_frame>
    <description>The online questionnaire will asses participants' mood using the Hospital Anxiety and Depression scale. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity beliefs, attitudes, barriers, and motivation from baseline to 3 months.</measure>
    <time_frame>Baseline, 6 weeks, 3 months</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. Changes in these measures will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity behaviour regulation from baseline to 3 months.</measure>
    <time_frame>Baseline, 6 weeks, 3 months</time_frame>
    <description>Included in questionnaire - 5 items adapted from Umstattd's scale measuring physical activity self-regulation strategies in older adults. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity habits from baseline to 3 months.</measure>
    <time_frame>Baseline, 6 weeks, 3 months</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 (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity identity from baseline to 3 months.</measure>
    <time_frame>Baseline, 6 weeks, 3 months</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. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Physical Activity</condition>
  <condition>Health Promotion</condition>
  <arm_group>
    <arm_group_label>Group 1 - Self monitored</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fitbit use and reports details: Participants will receive a Fitbit device to wear for 3 months. They will engage with the Fitbit application on their smartphone or tablet device and receive a Weekly Progress Report from Fitbit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 - Partner monitored</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fitbit use and reports details: Participant will receive a Fitbit device to wear for 3 months. They will engage with the Fitbit application on their smartphone or tablet device. Participant will also engage with their partner through the Fitbit application. They will have access to their partner's daily progress and be able to communicate through the application. They will also receive their partner's Weekly Fitbit Reports and have a weekly discussion about the Weekly Fitbit Report.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fitbit use and reports</intervention_name>
    <description>Participants will receive a Fitbit device to be used for the duration of the study. Participants will engage with the Fitbit and application and receive Weekly Progress Reports from Fitbit.</description>
    <arm_group_label>Group 1 - Self monitored</arm_group_label>
    <arm_group_label>Group 2 - Partner monitored</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Partner engagement</intervention_name>
    <description>Participants will be connected with their partner in the Fitbit app and therefore have the ability to access their partner's progress. Participants' Weekly Progress Reports will be automatically forwarded to their partner. Participants will engage in a weekly discussion on the topic of their Weekly Progress Reports.</description>
    <arm_group_label>Group 2 - Partner monitored</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  One or both partners currently not meeting the Canadian Physical Activity Guidelines&#xD;
             of 150 minutes of moderate to vigorous physical activity per week&#xD;
&#xD;
          -  Currently living in Victoria, BC&#xD;
&#xD;
          -  Safe to participate in physical activity (physician clearance required if applicable)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No smartphone or tablet device (with bluetooth technology)&#xD;
&#xD;
          -  No email address&#xD;
&#xD;
          -  No partner and/or not living with partner&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ryan Rhodes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Victoria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Scott Hofer, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Victoria</affiliation>
  </overall_official>
  <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_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>November 10, 2020</last_update_submitted>
  <last_update_submitted_qc>November 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</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, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Behavioural</keyword>
  <!-- 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/NCT03248752
org study id: BC17-180
nct id: NCT03248752
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the effect of monitoring and sharing physical
      activity outcomes (using Fitbit technology) with a domestic partner on physical activity
      participation.

      Primary research question: Does sharing physical activity outcomes from wearable technology
      with a participant's partner improve overall physical activity over 3 months compared to not
      sharing outcomes? Physical activity will be measured as minutes of moderate to vigorous
      physical activity per week.

      Hypothesis: Knowledge that physical activity outcomes are visible to a participant's partner
      will serve as a proxy-supervision intervention. Awareness of partner's progress will serve as
      further motivation. Both factors will improve physical activity adherence in comparison to
      participants without shared outcomes.
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 wearable fitness monitors such as Fitbits include
      components of several behavioral strategies including goal setting and feedback. While this
      technology provides a platform for implementing self-regulation techniques important for
      behavior change, direct supervision is still the most effective strategy for behavior change.
      Supervised exercise programs and personal trainers may not be accessible or affordable for
      people; this study will examine whether proxy supervision by a partner is effective in
      changing behavior compared to self-regulation alone.

      Target Population: Sedentary adults aged 45-75 years old living in Victoria,
      British-Columbia, Canada.

      Sample Size: 80 participant pairs (160 total participants), 40 pairs per group (80
      participants per group).

      Intervention: Participants will be randomized to two groups: 1 - Self Monitored, 2 - Partner
      monitored. Both groups will receive an intervention with Group 1 (Self monitored) serving as
      the comparison group. Participants from both groups will wear an accelerometer for 1 week and
      complete an online questionnaire at baseline, 6 weeks, and 3 months. Measures of height,
      weight, waist circumference, and resting blood pressure and heart rate will be taken at
      baseline and 3 months. Participants will all receive a Fitbit activity tracker and wear it
      for 3 months. Group 2 (Partner monitor) participants will also have access to their partner's
      daily progress, receive eachother's Weekly Fitbit reports, and engage in a weekly discussion
      related to their Weekly Fitbit Report.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Change from baseline in participants' weekly physical activity participation at 3 months.
time frame: Baseline, 6 weeks, and 3 months
description: Quantified as minutes of moderate to vigorous physical activity measured with accelerometry. Participants will wear an accelerometer for a minimum of 10 hours per day for 7 consecutive days. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
measure: Change in Body Mass Index from baseline to 3 months.
time frame: Baseline and 3 months
description: Standardized protocols for measuring weight in kilograms (kg) and height in centimeters (cm) will be performed as per the Canadian Society for Exercise Physiology guidelines. Body Mass Index (BMI) will be calculated as kg/m^2. Body Mass Index is an indicator of body composition which is associated with physical activity. Changes in BMI will be examined (3 months to baseline).
measure: Change in waist circumference from baseline to 3 months.
time frame: Baseline, 3 months
description: Standardized protocols for measuring waist circumference in centimeters (cm) will be performed as per the Canadian Society for Exercise Physiology guidelines. Waist circumference is an indicator of body composition which is associated with physical activity. Changes in waist circumference will be examined (3 months to baseline).
measure: Change in self-reported physical activity from baseline to 3 months.
time frame: Baseline, 6 weeks, 3 months.
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 15 minutes during free time in a typical week. Changes in these measures will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
measure: Change in quality of life from baseline to 3 months measured using the Short Form 12 questionnaire.
time frame: Baseline, 6 weeks, 3 months
description: The online questionnaire will asses participants' quality of life using the short form 12 questionnaire. Changes in this measures will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
measure: Change in life satisfaction from baseline to 3 months measured using Diener's satisfaction with life scale in a questionnaire.
time frame: Baseline, 6 weeks, 3 months
description: The online questionnaire will asses participants' life satisfaction using Diener's satisfaction with life scale. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
measure: Change in mood from baseline to 3 months measured using the Hospital Anxiety and Depression Scale in a questionnaire.
time frame: Baseline, 6 weeks, 3 months
description: The online questionnaire will asses participants' mood using the Hospital Anxiety and Depression scale. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
measure: Change in physical activity beliefs, attitudes, barriers, and motivation from baseline to 3 months.
time frame: Baseline, 6 weeks, 3 months
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. Changes in these measures will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
measure: Change in physical activity behaviour regulation from baseline to 3 months.
time frame: Baseline, 6 weeks, 3 months
description: Included in questionnaire - 5 items adapted from Umstattd's scale measuring physical activity self-regulation strategies in older adults. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
measure: Change in physical activity habits from baseline to 3 months.
time frame: Baseline, 6 weeks, 3 months
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 (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
measure: Change in physical activity identity from baseline to 3 months.
time frame: Baseline, 6 weeks, 3 months
description: Included in questionnaire - Anderson and Cychosz Exercise Identity Scale is used to measure participants' identification as someone who participates in physical activity. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
arm group label: Group 1 - Self monitored
arm group type: Active Comparator
description: Fitbit use and reports details: Participants will receive a Fitbit device to wear for 3 months. They will engage with the Fitbit application on their smartphone or tablet device and receive a Weekly Progress Report from Fitbit.
arm group label: Group 2 - Partner monitored
arm group type: Experimental
description: Fitbit use and reports details: Participant will receive a Fitbit device to wear for 3 months. They will engage with the Fitbit application on their smartphone or tablet device. Participant will also engage with their partner through the Fitbit application. They will have access to their partner's daily progress and be able to communicate through the application. They will also receive their partner's Weekly Fitbit Reports and have a weekly discussion about the Weekly Fitbit Report.
intervention type: Behavioral
intervention name: Fitbit use and reports
description: Participants will receive a Fitbit device to be used for the duration of the study. Participants will engage with the Fitbit and application and receive Weekly Progress Reports from Fitbit.
arm group label: Group 1 - Self monitored
arm group label: Group 2 - Partner monitored
intervention type: Behavioral
intervention name: Partner engagement
description: Participants will be connected with their partner in the Fitbit app and therefore have the ability to access their partner's progress. Participants' Weekly Progress Reports will be automatically forwarded to their partner. Participants will engage in a weekly discussion on the topic of their Weekly Progress Reports.
arm group label: Group 2 - Partner monitored
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ryan Rhodes, PhD
role: Principal Investigator
affiliation: University of Victoria
last name: Scott Hofer, PhD
role: Study Chair
affiliation: University of Victoria
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Victoria
investigator full name: Ryan Rhodes
investigator title: Professor, Principal Investigator