<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/NCT03760393</url>
  </required_header>
  <id_info>
    <org_study_id>HAPA Planning &amp; SB in Students</org_study_id>
    <nct_id>NCT03760393</nct_id>
  </id_info>
  <brief_title>A Combined HAPA and mHealth Intervention to Reduce Sedentary Behaviour in University Students</brief_title>
  <official_title>Using a Combined Health Action Process Approach and mHealth Intervention to Reduce Sedentary Behaviour in University Students - A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western University, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western University, Canada</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>
      Societal changes have resulted in reduced demands to be active and increased daily time spent&#xD;
      sitting. Sedentary behavior (SB) has been linked to many health problems such as type 2&#xD;
      diabetes and heart disease. University students are a high-risk population for excessive SB.&#xD;
      Increasing the length and frequency of breaks from sitting and increasing the time spent&#xD;
      standing and engaged in light physical activity are ways to decrease SB. The purpose of this&#xD;
      study is to determine whether combining a Health Action Process Approach-based&#xD;
      (theory-driven), specifically action and coping planning intervention, with a tailored text&#xD;
      messaging intervention can reduce occupational (student) sitting time among university&#xD;
      students. Participants in the intervention group will receive one behavioural counselling&#xD;
      session, followed by daily, tailored text messages over a 6-week period, with a focus on&#xD;
      encouraging them to reduce their sitting time as a student by increasing their frequency and&#xD;
      duration of breaks from sitting, as well as time spent standing and engaged in&#xD;
      light-intensity physical activity. It is expected that university students who receive the&#xD;
      planning intervention and tailored text messages will report greater increases in&#xD;
      non-sedentary behaviours (e.g., break frequency, break duration, standing, light physical&#xD;
      activity) than those who do not receive the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using a randomized controlled trial design, the purpose of this study will be to examine&#xD;
      whether combining a Health Action Process Approach (HAPA)-based intervention, specifically&#xD;
      action and coping planning, with a tailored text message intervention can reduce occupational&#xD;
      (student) sitting time by increasing frequency and length of breaks from sitting and&#xD;
      non-exercise activity thermogenesis (NEAT) behaviours (i.e., standing, light-intensity&#xD;
      physical activity) among university students. A secondary purpose will be to examine the&#xD;
      effects of the intervention on participants' action planning, coping planning and action&#xD;
      control regarding reducing their sitting time as a student, as well as self-rated work&#xD;
      performance and health-related outcomes (i.e., role limitations due to physical health, role&#xD;
      limitations due to personal or emotional problems, emotional well-being, and energy/fatigue).&#xD;
      Another secondary objective will be to determine if action and coping planning and action&#xD;
      control towards reducing occupational (student) sitting time are related to actual break&#xD;
      behaviour, time spent standing, and time spent in light-intensity physical activity.&#xD;
&#xD;
      If successful, participants in the intervention group (sedentary intervention group) will&#xD;
      report greater break frequency and break duration, time spent standing, and time spent in&#xD;
      light-intensity physical activity, compared to participants in the control group (no&#xD;
      treatment). In addition, it is hypothesized that participants in the intervention group will&#xD;
      report greater action and coping planning and action control towards reducing sitting time as&#xD;
      a student, as well as improved work- and health-related outcomes.&#xD;
&#xD;
      This study will employ a prospective, 2-group, repeated measure, randomized controlled trial&#xD;
      (RCT) design. Participants will be full-time university and/or college students.&#xD;
&#xD;
      Potential participants (estimated enrolment: 112) will be recruited by Andrew Scott Rollo,&#xD;
      Co-Investigator, for this study. Participants will be recruited from (1) undergraduate and&#xD;
      graduate classes at the University of Western Ontario. Professors across faculties at UWO&#xD;
      will be contacted via email and asked to (a) distribute the recruitment poster and study&#xD;
      invitation to students in their course(s), and/or (b) allow study investigator(s) to provide&#xD;
      a short presentation during their lecture time. The opportunity for students to participate&#xD;
      will be posted on their UWO OWL site, as well as presented in their class. Participants will&#xD;
      be instructed to contact the researcher via email and/or phone if they wish to participate or&#xD;
      receive additional details prior to making a decision as to whether to participate. A second&#xD;
      recruitment approach will involve recruiting full-time university and/or college students&#xD;
      through recruitment posters distributed through social media (i.e., Facebook, LinkedIn).&#xD;
      Recruitment posters and brief study details will be posted on social media. For social media&#xD;
      outlets, permission from group administrators will be sought prior to posting social media&#xD;
      recruitment materials, as applicable. As stated previous, university students interested in&#xD;
      the study will be instructed to contact the researcher via email and/or phone to sign up for&#xD;
      study participation.&#xD;
&#xD;
      At this point of contact, an email response will be sent to any interested individual.&#xD;
      University students who choose to take part in this study will receive a link (with serial&#xD;
      number authorization code) via email that directs them to the Letter of Information,&#xD;
      electronic Informed Consent, and questionnaire for assessment of baseline measurements, which&#xD;
      will be administered through a third party website called SoSci (online survey service).&#xD;
      After viewing the Letter of Information and indicating that they consent to participate in&#xD;
      the study (by clicking &quot;I agree&quot; on the survey), participants will be asked to complete a&#xD;
      brief demographics questionnaire, followed by a questionnaire for baseline assessment of&#xD;
      primary and secondary outcomes.&#xD;
&#xD;
      Upon completion of the Baseline assessment and prior to intervention delivery, all&#xD;
      participants will be randomized, using computer-generated randomized stratification, into&#xD;
      either a 6-week HAPA-treatment (SB-related planning + text messages intervention) or&#xD;
      waitlisted control (no treatment) condition.&#xD;
&#xD;
      At this point, all participants will be sent a specific email (outlined below) depending on&#xD;
      group assignment.&#xD;
&#xD;
      In the post-baseline questionnaire EMAIL response sent to intervention participants,&#xD;
      participants (randomly assigned to the intervention group only) will be asked to provide a&#xD;
      day and time (within 3 days of completing the baseline assessment) that they would be&#xD;
      available to schedule the behavioural counselling session they will receive. As a follow-up&#xD;
      to electronic consent, written consent will be obtained during administration of the&#xD;
      behavioural counselling session.&#xD;
&#xD;
      In the post-baseline questionnaire EMAIL response sent to control participants, they will&#xD;
      simply be reminded that they will receive a link to a questionnaire every two week for 8&#xD;
      weeks in their email and will be asked to complete these upon receiving them. Participants in&#xD;
      the control group will also be asked to SIGN and RETURN the LOI/written informed consent via&#xD;
      email at their earliest convenience.&#xD;
&#xD;
      For those in the treatment group, the study objective will be to reduce occupational&#xD;
      (student) sitting time by increasing non- sedentary or NEAT behaviours (i.e., increasing&#xD;
      break frequency to a break every 30-45 minutes, with each break having a duration of 2-4&#xD;
      minutes, and increasing their time spent standing and engaged in light- intensity PA.&#xD;
      Participants randomly assigned to the control group will receive no information or&#xD;
      intervention of any kind and will only be asked to complete the outcome questionnaires.&#xD;
&#xD;
      At the agreed upon and scheduled time, the researcher will deliver the intervention (i.e.,&#xD;
      implement the appropriate HAPA-based behavioural counselling session involving action and&#xD;
      coping planning) either in person OR electronically via phone and an online presentation&#xD;
      website (www.zoho.com) (only for those randomized into the intervention group). The method of&#xD;
      delivery will entirely depend on the participant's availability, preference, and whether they&#xD;
      live within driving distance of the investigator. To ensure equal numbers of local and remote&#xD;
      participants, two computer-generated random number lists will be created by the lead&#xD;
      investigator using an online research randomization program. Participants will be asked to&#xD;
      complete a second informed consent (i.e., written informed consent) at this time.&#xD;
&#xD;
      The one-on-one counseling sessions will be delivered by the principal investigator to ensure&#xD;
      standardization between participants. During the counseling session, the researcher will&#xD;
      first ask if the participant has any strategies that he/she would like to try or think would&#xD;
      be effective. As much as possible, strategies will be kept as original and specific to the&#xD;
      participant's lifestyle as possible, while still fulfilling the study objectives. Upon&#xD;
      creation of each strategy, the researcher will ask the participant if they think that the&#xD;
      strategy they came up with is realistic. The number of strategies will also be personalized&#xD;
      depending on how the participant's baseline measures compare to the objectives of their&#xD;
      treatment group. This will be done in order to attenuate for any neglected/unused strategies&#xD;
      by those with larger differences between baseline and objective values. Similarly, coping&#xD;
      strategies will be created alongside each strategy in order to boost the adherence to the&#xD;
      developed strategies. When an action plan strategy is developed, the researcher will ask the&#xD;
      participant &quot;what are some challenges you foresee with executing this strategy?&quot;, followed by&#xD;
      &quot;what do you think is something we can do in order to overcome this/these challenges?&quot; This&#xD;
      will be done in order to keep the coping strategies personalized to the participant's&#xD;
      lifestyle. Overall, the behavioral counseling sessions will take approximately 20 minutes to&#xD;
      complete. Participants will be given the form with their action plan and coping strategies&#xD;
      and told to display it somewhere prominent so they will be reminded of the strategies. The&#xD;
      principal investigator will conduct the planning interventions in a non-interfering manner by&#xD;
      providing brief instructions and then remaining available to answer any questions.&#xD;
&#xD;
      All participants in the HAPA-treatment condition will then be entered into a contact list on&#xD;
      the text-messaging website called &quot;Oh Don't Forget.&quot; &quot;Oh Don't Forget,&quot; is a Web-based&#xD;
      application (http://ohdontforget.com) that works through &quot;Recess Mobile&quot; to send messages&#xD;
      from a computer to mobile phone numbers that are programmed into the application. All&#xD;
      participants will begin receiving tailored text messages the day after receiving their&#xD;
      one-on-one counseling session. Every participant will receive the same daily texts as each&#xD;
      other participant in their group, with times varying slightly depending on their schedule. As&#xD;
      planning is an ongoing process, participants will be reminded (via text message) to formulate&#xD;
      another set of action and coping plans at the beginning of weeks 3 and 5. Upon completion of&#xD;
      the intervention period at 6 weeks, participants will be notified that they will no longer be&#xD;
      receiving text messages and that the study is completed.&#xD;
&#xD;
      After the initial behavioural counseling session, ALL participants will be told they will&#xD;
      receive a link to a questionnaire (assessment of primary and secondary outcomes) in their&#xD;
      email every 2 weeks, for the next 6 weeks (i.e., weeks 2, 4, and 6), and to complete the&#xD;
      questionnaire the day they receive it. Participants will also be told that 2 weeks following&#xD;
      the end of the 6-week intervention, there will be a follow-up questionnaire (week 8), which&#xD;
      they will receive and be asked to complete. Regardless of group assignment, all participants&#xD;
      will complete the same outcome measures at Baseline, 2 weeks, 4 weeks, 6 weeks, and 2-week&#xD;
      follow-up (8 weeks). All primary and secondary outcome questionnaires will be completed&#xD;
      online and administered through a third party website called SoSci (online survey service).&#xD;
      Participants in the HAPA-treatment condition will also be reminded via text to complete&#xD;
      these.&#xD;
&#xD;
      The primary outcomes including frequency of breaks, length of breaks, and NEAT behaviours&#xD;
      (i.e., standing, light- intensity PA) in the occupational domain of study (i.e., as a&#xD;
      student) will be assessed using subjective, self-report approaches. Secondary analyses will&#xD;
      be performed to examine effects of the intervention on theoretical determinants of behaviour&#xD;
      change (i.e., action planning, coping planning, action control), as well as participants'&#xD;
      perceived work-related outcomes (i.e., self-rated work performance) and health-related&#xD;
      outcomes (i.e., role limitations due to physical health, role limitations due to personal or&#xD;
      emotional problems, emotional well-being, and energy/fatigue). All primary outcomes will be&#xD;
      assessed at four time points (baseline, 2, 4, and 6 weeks), and again at a two-week follow-up&#xD;
      (8 weeks). Action and coping planning and action control towards reducing occupational&#xD;
      (student) sitting time will be assessed at the same time points. Secondary outcome variables&#xD;
      (i.e., perceived work- and health-related outcomes) will be assessed pre- (baseline) and&#xD;
      post-intervention (6 weeks).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</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>This study will employ a prospective, 2-group, repeated measure (2x5), randomized controlled trial (RCT) design. All participants will be randomized into either a 6-week HAPA-treatment (SB-related planning + text messages intervention) or waitlisted control (no treatment) condition.&#xD;
All primary outcomes will be assessed at four time points (baseline, 2, 4, and 6 weeks), and again at a two-week follow-up (8 weeks). Action and coping planning and action control towards reducing occupational (student) sitting time will be assessed at the same time points. Secondary outcome assessments (i.e., work- and health-related outcomes) will occur pre-(baseline) and post-intervention (6 weeks).</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Frequency of Breaks from Sitting as a Student</measure>
    <time_frame>Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)</time_frame>
    <description>Modified version of the SIT-Q 7d (Wijndaele et al., 2014; Sui &amp; Prapavessis, 2016); 1-item; 12-point scale (Less than every 30 min, Every 30-45 min, Every 45 min-1 hour, Every 1-1.5 hours, Every 1.5-2 hours, Every 2-3 hours, Every 3-4 hours, Every 4-5 hours, Over every 5 hours, No interruption). Lower values represent a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Duration of Breaks from Sitting as a Student</measure>
    <time_frame>Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)</time_frame>
    <description>Modified version of the SIT-Q 7d (Wijndaele et al., 2014; Sui &amp; Prapavessis, 2016); 1-item; 10-point scale (Less than 30 sec, 30 sec-1 min, 1-2 min, 2-3 min, 3-4 min, 4-5 min, 5-10 min, 10-15 min, 15-30 min, Over 30 min). Higher values represent a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Time Spent Standing as a Student</measure>
    <time_frame>Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)</time_frame>
    <description>Five-item modified Occupational Sitting and Physical Activity Questionnaire (OSPAQ; Chau, Van Der Ploeg, Dunn, Kurko, &amp; Bauman, 2012)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Time Spent Engaged in Light-Intensity Physical Activity (i.e., walking) as a Student</measure>
    <time_frame>Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)</time_frame>
    <description>Five-item modified Occupational Sitting and Physical Activity Questionnaire (OSPAQ; Chau, Van Der Ploeg, Dunn, Kurko, &amp; Bauman, 2012)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Action Planning towards reducing occupational (student) sitting time</measure>
    <time_frame>Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)</time_frame>
    <description>Four-items; five-point Likert scale (1 = &quot;completely disagree&quot; to 5 = &quot;totally agree&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coping Planning towards reducing occupational (student) sitting time</measure>
    <time_frame>Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)</time_frame>
    <description>Five-items; five-point Likert scale (1 = &quot;completely disagree&quot; to 5 = &quot;totally agree&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Action Control towards reducing occupational (student) sitting time</measure>
    <time_frame>Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)</time_frame>
    <description>Six-items; five-point Likert scale (1 = &quot;completely disagree&quot; to 5 = &quot;totally agree&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated Work Performance</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>One-item, 11-point Likert scale (0-10; 0 = Absolutely unacceptable, 10 = Absolutely Ideal). Higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Role limitations due to physical health</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>RAND 36-item Short Form Survey (SF-36; Ware and Sherbourne, 1992) modified version (16-item). Four-items will assess participant's perceived role limitations due to physical health problems; 2-point scale (yes, no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Role limitations due to emotional health</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>RAND 36-item Short Form Survey (SF-36; Ware and Sherbourne, 1992) modified version (16-item). Three-items will assess role limitations due to personal or emotional problems; 2-point scale (yes, no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional well-being</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>RAND 36-item Short Form Survey (SF-36; Ware and Sherbourne, 1992) modified version (16-item). Five-items will assess perceived emotional well-being; 5-point Likert scale (All of the time =1, Most of the time = 2, Some of the time = 3, A little of the time = 4, None of the time = 5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy/Fatigue</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>RAND 36-item Short Form Survey (SF-36; Ware and Sherbourne, 1992) modified version (16-item). Four-items will assess perceived energy/fatigue; 5-point Likert scale (All of the time =1, Most of the time = 2, Some of the time = 3, A little of the time = 4, None of the time = 5)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Sedentary Lifestyle</condition>
  <condition>Health Behaviour Change</condition>
  <arm_group>
    <arm_group_label>HAPA-treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>(SB-related planning + daily text messages)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>(No Treatment) Participants randomly assigned to the control group will receive no information or intervention of any kind and will only be asked to complete the outcome questionnaires.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>(SB-related planning + daily text messages)</intervention_name>
    <description>Participants will receive a one-on-one behavioral counseling session, and planning sheet as reference for developing strategies as part of their Action/Coping Plan. Participants will be asked to form 3-4 actions plans specifying when, where, how, and for how long they would reduce occupational (student) sitting time; and anticipate potential barriers and identify ways they could be overcome. Strategies will explicitly focus on the ultimate objective of increasing break frequency to every 30-45 minutes, achieving a break duration of 2-3 minutes, and increasing time spent standing and engaged in light-intensity PA, in the occupational domain (i.e. as a student; during school-related activities).&#xD;
Participants will also receive sedentary behaviour-related text messages twice daily, depending on their preferences and schedule, which will act as mini-booster interventions.</description>
    <arm_group_label>HAPA-treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be 18+ years of age&#xD;
&#xD;
          -  Must be a full-time university and/or college student&#xD;
&#xD;
          -  Must be in self-reported good mental and physical health&#xD;
&#xD;
          -  Must be able to read and write in English&#xD;
&#xD;
          -  Must have access to a computer with Internet&#xD;
&#xD;
          -  Must own a mobile phone with free unlimited incoming text messages.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Do not read or write in English&#xD;
&#xD;
          -  Not a full-time university and/or college student&#xD;
&#xD;
          -  Do not have access to a computer with Internet&#xD;
&#xD;
          -  Do not own a mobile phone with free unlimited incoming text messages and/or emails&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Medical condition that prohibits individual from being physically active.&#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>The University of Western Ontario</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 24, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western University, Canada</investigator_affiliation>
    <investigator_full_name>Dr. Harry Prapavessis</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Sedentary Behaviour</keyword>
  <keyword>Health Behaviour Change</keyword>
  <keyword>Health Action Process Approach</keyword>
  <keyword>mHealth</keyword>
  <keyword>Intervention</keyword>
  <keyword>Non-Sedentary Behaviours</keyword>
  <keyword>Break Frequency</keyword>
  <keyword>Break Duration</keyword>
  <keyword>Action Planning</keyword>
  <keyword>Coping Planning</keyword>
  <keyword>Work Performance</keyword>
  <keyword>Health Outcomes</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/NCT03760393
org study id: HAPA Planning & SB in Students
nct id: NCT03760393
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Societal changes have resulted in reduced demands to be active and increased daily time spent
      sitting. Sedentary behavior (SB) has been linked to many health problems such as type 2
      diabetes and heart disease. University students are a high-risk population for excessive SB.
      Increasing the length and frequency of breaks from sitting and increasing the time spent
      standing and engaged in light physical activity are ways to decrease SB. The purpose of this
      study is to determine whether combining a Health Action Process Approach-based
      (theory-driven), specifically action and coping planning intervention, with a tailored text
      messaging intervention can reduce occupational (student) sitting time among university
      students. Participants in the intervention group will receive one behavioural counselling
      session, followed by daily, tailored text messages over a 6-week period, with a focus on
      encouraging them to reduce their sitting time as a student by increasing their frequency and
      duration of breaks from sitting, as well as time spent standing and engaged in
      light-intensity physical activity. It is expected that university students who receive the
      planning intervention and tailored text messages will report greater increases in
      non-sedentary behaviours (e.g., break frequency, break duration, standing, light physical
      activity) than those who do not receive the intervention.
Using a randomized controlled trial design, the purpose of this study will be to examine
      whether combining a Health Action Process Approach (HAPA)-based intervention, specifically
      action and coping planning, with a tailored text message intervention can reduce occupational
      (student) sitting time by increasing frequency and length of breaks from sitting and
      non-exercise activity thermogenesis (NEAT) behaviours (i.e., standing, light-intensity
      physical activity) among university students. A secondary purpose will be to examine the
      effects of the intervention on participants' action planning, coping planning and action
      control regarding reducing their sitting time as a student, as well as self-rated work
      performance and health-related outcomes (i.e., role limitations due to physical health, role
      limitations due to personal or emotional problems, emotional well-being, and energy/fatigue).
      Another secondary objective will be to determine if action and coping planning and action
      control towards reducing occupational (student) sitting time are related to actual break
      behaviour, time spent standing, and time spent in light-intensity physical activity.

      If successful, participants in the intervention group (sedentary intervention group) will
      report greater break frequency and break duration, time spent standing, and time spent in
      light-intensity physical activity, compared to participants in the control group (no
      treatment). In addition, it is hypothesized that participants in the intervention group will
      report greater action and coping planning and action control towards reducing sitting time as
      a student, as well as improved work- and health-related outcomes.

      This study will employ a prospective, 2-group, repeated measure, randomized controlled trial
      (RCT) design. Participants will be full-time university and/or college students.

      Potential participants (estimated enrolment: 112) will be recruited by Andrew Scott Rollo,
      Co-Investigator, for this study. Participants will be recruited from (1) undergraduate and
      graduate classes at the University of Western Ontario. Professors across faculties at UWO
      will be contacted via email and asked to (a) distribute the recruitment poster and study
      invitation to students in their course(s), and/or (b) allow study investigator(s) to provide
      a short presentation during their lecture time. The opportunity for students to participate
      will be posted on their UWO OWL site, as well as presented in their class. Participants will
      be instructed to contact the researcher via email and/or phone if they wish to participate or
      receive additional details prior to making a decision as to whether to participate. A second
      recruitment approach will involve recruiting full-time university and/or college students
      through recruitment posters distributed through social media (i.e., Facebook, LinkedIn).
      Recruitment posters and brief study details will be posted on social media. For social media
      outlets, permission from group administrators will be sought prior to posting social media
      recruitment materials, as applicable. As stated previous, university students interested in
      the study will be instructed to contact the researcher via email and/or phone to sign up for
      study participation.

      At this point of contact, an email response will be sent to any interested individual.
      University students who choose to take part in this study will receive a link (with serial
      number authorization code) via email that directs them to the Letter of Information,
      electronic Informed Consent, and questionnaire for assessment of baseline measurements, which
      will be administered through a third party website called SoSci (online survey service).
      After viewing the Letter of Information and indicating that they consent to participate in
      the study (by clicking "I agree" on the survey), participants will be asked to complete a
      brief demographics questionnaire, followed by a questionnaire for baseline assessment of
      primary and secondary outcomes.

      Upon completion of the Baseline assessment and prior to intervention delivery, all
      participants will be randomized, using computer-generated randomized stratification, into
      either a 6-week HAPA-treatment (SB-related planning + text messages intervention) or
      waitlisted control (no treatment) condition.

      At this point, all participants will be sent a specific email (outlined below) depending on
      group assignment.

      In the post-baseline questionnaire EMAIL response sent to intervention participants,
      participants (randomly assigned to the intervention group only) will be asked to provide a
      day and time (within 3 days of completing the baseline assessment) that they would be
      available to schedule the behavioural counselling session they will receive. As a follow-up
      to electronic consent, written consent will be obtained during administration of the
      behavioural counselling session.

      In the post-baseline questionnaire EMAIL response sent to control participants, they will
      simply be reminded that they will receive a link to a questionnaire every two week for 8
      weeks in their email and will be asked to complete these upon receiving them. Participants in
      the control group will also be asked to SIGN and RETURN the LOI/written informed consent via
      email at their earliest convenience.

      For those in the treatment group, the study objective will be to reduce occupational
      (student) sitting time by increasing non- sedentary or NEAT behaviours (i.e., increasing
      break frequency to a break every 30-45 minutes, with each break having a duration of 2-4
      minutes, and increasing their time spent standing and engaged in light- intensity PA.
      Participants randomly assigned to the control group will receive no information or
      intervention of any kind and will only be asked to complete the outcome questionnaires.

      At the agreed upon and scheduled time, the researcher will deliver the intervention (i.e.,
      implement the appropriate HAPA-based behavioural counselling session involving action and
      coping planning) either in person OR electronically via phone and an online presentation
      website (www.zoho.com) (only for those randomized into the intervention group). The method of
      delivery will entirely depend on the participant's availability, preference, and whether they
      live within driving distance of the investigator. To ensure equal numbers of local and remote
      participants, two computer-generated random number lists will be created by the lead
      investigator using an online research randomization program. Participants will be asked to
      complete a second informed consent (i.e., written informed consent) at this time.

      The one-on-one counseling sessions will be delivered by the principal investigator to ensure
      standardization between participants. During the counseling session, the researcher will
      first ask if the participant has any strategies that he/she would like to try or think would
      be effective. As much as possible, strategies will be kept as original and specific to the
      participant's lifestyle as possible, while still fulfilling the study objectives. Upon
      creation of each strategy, the researcher will ask the participant if they think that the
      strategy they came up with is realistic. The number of strategies will also be personalized
      depending on how the participant's baseline measures compare to the objectives of their
      treatment group. This will be done in order to attenuate for any neglected/unused strategies
      by those with larger differences between baseline and objective values. Similarly, coping
      strategies will be created alongside each strategy in order to boost the adherence to the
      developed strategies. When an action plan strategy is developed, the researcher will ask the
      participant "what are some challenges you foresee with executing this strategy?", followed by
      "what do you think is something we can do in order to overcome this/these challenges?" This
      will be done in order to keep the coping strategies personalized to the participant's
      lifestyle. Overall, the behavioral counseling sessions will take approximately 20 minutes to
      complete. Participants will be given the form with their action plan and coping strategies
      and told to display it somewhere prominent so they will be reminded of the strategies. The
      principal investigator will conduct the planning interventions in a non-interfering manner by
      providing brief instructions and then remaining available to answer any questions.

      All participants in the HAPA-treatment condition will then be entered into a contact list on
      the text-messaging website called "Oh Don't Forget." "Oh Don't Forget," is a Web-based
      application (http://ohdontforget.com) that works through "Recess Mobile" to send messages
      from a computer to mobile phone numbers that are programmed into the application. All
      participants will begin receiving tailored text messages the day after receiving their
      one-on-one counseling session. Every participant will receive the same daily texts as each
      other participant in their group, with times varying slightly depending on their schedule. As
      planning is an ongoing process, participants will be reminded (via text message) to formulate
      another set of action and coping plans at the beginning of weeks 3 and 5. Upon completion of
      the intervention period at 6 weeks, participants will be notified that they will no longer be
      receiving text messages and that the study is completed.

      After the initial behavioural counseling session, ALL participants will be told they will
      receive a link to a questionnaire (assessment of primary and secondary outcomes) in their
      email every 2 weeks, for the next 6 weeks (i.e., weeks 2, 4, and 6), and to complete the
      questionnaire the day they receive it. Participants will also be told that 2 weeks following
      the end of the 6-week intervention, there will be a follow-up questionnaire (week 8), which
      they will receive and be asked to complete. Regardless of group assignment, all participants
      will complete the same outcome measures at Baseline, 2 weeks, 4 weeks, 6 weeks, and 2-week
      follow-up (8 weeks). All primary and secondary outcome questionnaires will be completed
      online and administered through a third party website called SoSci (online survey service).
      Participants in the HAPA-treatment condition will also be reminded via text to complete
      these.

      The primary outcomes including frequency of breaks, length of breaks, and NEAT behaviours
      (i.e., standing, light- intensity PA) in the occupational domain of study (i.e., as a
      student) will be assessed using subjective, self-report approaches. Secondary analyses will
      be performed to examine effects of the intervention on theoretical determinants of behaviour
      change (i.e., action planning, coping planning, action control), as well as participants'
      perceived work-related outcomes (i.e., self-rated work performance) and health-related
      outcomes (i.e., role limitations due to physical health, role limitations due to personal or
      emotional problems, emotional well-being, and energy/fatigue). All primary outcomes will be
      assessed at four time points (baseline, 2, 4, and 6 weeks), and again at a two-week follow-up
      (8 weeks). Action and coping planning and action control towards reducing occupational
      (student) sitting time will be assessed at the same time points. Secondary outcome variables
      (i.e., perceived work- and health-related outcomes) will be assessed pre- (baseline) and
      post-intervention (6 weeks).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study will employ a prospective, 2-group, repeated measure (2x5), randomized controlled trial (RCT) design. All participants will be randomized into either a 6-week HAPA-treatment (SB-related planning + text messages intervention) or waitlisted control (no treatment) condition.
All primary outcomes will be assessed at four time points (baseline, 2, 4, and 6 weeks), and again at a two-week follow-up (8 weeks). Action and coping planning and action control towards reducing occupational (student) sitting time will be assessed at the same time points. Secondary outcome assessments (i.e., work- and health-related outcomes) will occur pre-(baseline) and post-intervention (6 weeks).
primary purpose: Prevention
masking: None (Open Label)
measure: Changes in Frequency of Breaks from Sitting as a Student
time frame: Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)
description: Modified version of the SIT-Q 7d (Wijndaele et al., 2014; Sui & Prapavessis, 2016); 1-item; 12-point scale (Less than every 30 min, Every 30-45 min, Every 45 min-1 hour, Every 1-1.5 hours, Every 1.5-2 hours, Every 2-3 hours, Every 3-4 hours, Every 4-5 hours, Over every 5 hours, No interruption). Lower values represent a better outcome.
measure: Changes in Duration of Breaks from Sitting as a Student
time frame: Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)
description: Modified version of the SIT-Q 7d (Wijndaele et al., 2014; Sui & Prapavessis, 2016); 1-item; 10-point scale (Less than 30 sec, 30 sec-1 min, 1-2 min, 2-3 min, 3-4 min, 4-5 min, 5-10 min, 10-15 min, 15-30 min, Over 30 min). Higher values represent a better outcome.
measure: Changes in Time Spent Standing as a Student
time frame: Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)
description: Five-item modified Occupational Sitting and Physical Activity Questionnaire (OSPAQ; Chau, Van Der Ploeg, Dunn, Kurko, & Bauman, 2012)
measure: Changes in Time Spent Engaged in Light-Intensity Physical Activity (i.e., walking) as a Student
time frame: Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)
description: Five-item modified Occupational Sitting and Physical Activity Questionnaire (OSPAQ; Chau, Van Der Ploeg, Dunn, Kurko, & Bauman, 2012)
measure: Action Planning towards reducing occupational (student) sitting time
time frame: Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)
description: Four-items; five-point Likert scale (1 = "completely disagree" to 5 = "totally agree")
measure: Coping Planning towards reducing occupational (student) sitting time
time frame: Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)
description: Five-items; five-point Likert scale (1 = "completely disagree" to 5 = "totally agree")
measure: Action Control towards reducing occupational (student) sitting time
time frame: Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)
description: Six-items; five-point Likert scale (1 = "completely disagree" to 5 = "totally agree")
measure: Self-rated Work Performance
time frame: Baseline, Week 6
description: One-item, 11-point Likert scale (0-10; 0 = Absolutely unacceptable, 10 = Absolutely Ideal). Higher values represent a better outcome.
measure: Role limitations due to physical health
time frame: Baseline, Week 6
description: RAND 36-item Short Form Survey (SF-36; Ware and Sherbourne, 1992) modified version (16-item). Four-items will assess participant's perceived role limitations due to physical health problems; 2-point scale (yes, no)
measure: Role limitations due to emotional health
time frame: Baseline, Week 6
description: RAND 36-item Short Form Survey (SF-36; Ware and Sherbourne, 1992) modified version (16-item). Three-items will assess role limitations due to personal or emotional problems; 2-point scale (yes, no)
measure: Emotional well-being
time frame: Baseline, Week 6
description: RAND 36-item Short Form Survey (SF-36; Ware and Sherbourne, 1992) modified version (16-item). Five-items will assess perceived emotional well-being; 5-point Likert scale (All of the time =1, Most of the time = 2, Some of the time = 3, A little of the time = 4, None of the time = 5)
measure: Energy/Fatigue
time frame: Baseline, Week 6
description: RAND 36-item Short Form Survey (SF-36; Ware and Sherbourne, 1992) modified version (16-item). Four-items will assess perceived energy/fatigue; 5-point Likert scale (All of the time =1, Most of the time = 2, Some of the time = 3, A little of the time = 4, None of the time = 5)
arm group label: HAPA-treatment
arm group type: Experimental
description: (SB-related planning + daily text messages)
arm group label: Control
arm group type: No Intervention
description: (No Treatment) Participants randomly assigned to the control group will receive no information or intervention of any kind and will only be asked to complete the outcome questionnaires.
intervention type: Behavioral
intervention name: (SB-related planning + daily text messages)
description: Participants will receive a one-on-one behavioral counseling session, and planning sheet as reference for developing strategies as part of their Action/Coping Plan. Participants will be asked to form 3-4 actions plans specifying when, where, how, and for how long they would reduce occupational (student) sitting time; and anticipate potential barriers and identify ways they could be overcome. Strategies will explicitly focus on the ultimate objective of increasing break frequency to every 30-45 minutes, achieving a break duration of 2-3 minutes, and increasing time spent standing and engaged in light-intensity PA, in the occupational domain (i.e. as a student; during school-related activities).
Participants will also receive sedentary behaviour-related text messages twice daily, depending on their preferences and schedule, which will act as mini-booster interventions.
arm group label: HAPA-treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Western University, Canada
investigator full name: Dr. Harry Prapavessis
investigator title: Professor