<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/NCT03799146</url>
  </required_header>
  <id_info>
    <org_study_id>MyPlan2.0_older_adults_50</org_study_id>
    <nct_id>NCT03799146</nct_id>
  </id_info>
  <brief_title>Identifying the Effect and Working Mechanisms of MyPlan 2.0 in Older Adults</brief_title>
  <official_title>A Randomized Controlled Trial to Identify the Effect and the Working Mechanisms of MyPlan 2.0, a Self-regulation-based e- and mHealth Intervention Targeting Physical Activity and Sedentary Behaviour, in Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Ghent</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 aim of this study is to investigate whether and how 'MyPlan 2.0' helps older adults to be&#xD;
      more physically active or less sedentary. Two groups will be created, an intervention group&#xD;
      and a waiting-list control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to investigate whether and how 'MyPlan 2.0' helps older adults to be&#xD;
      more physically active or less sedentary. Two groups will be created, an intervention group&#xD;
      and a waiting-list control group. Both groups will be tested during three testing waves:&#xD;
      pretest, posttest and follow-up test. Only the intervention group will be given acces to&#xD;
      'MyPlan 2.0'.&#xD;
&#xD;
      'MyPlan 2.0' consists of a website and mobile application targeting physical activity and&#xD;
      sedentary behaviour. The intervention has a duration of five weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Actual">April 15, 2019</completion_date>
  <primary_completion_date type="Actual">August 15, 2018</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>Randomized controlled trial with two groups: intervention group and waiting-list control group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in objective total, light and moderate-to-vigorous physical activity (PA)</measure>
    <time_frame>Pretest, posttest (6 weeks) and follow-up (6 months)</time_frame>
    <description>Change in amount of total, light and moderate-to-vigorous physical activity, measured via accelerometers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in objective sedentary behaviour</measure>
    <time_frame>Pretest, posttest (6 weeks) and follow-up (6 months)</time_frame>
    <description>Change in amount of total sitting time, measured via accelerometers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-reported total, moderate and moderate-to-vigorous physical activity (PA) as well as total work-related, transport-related, household-related and leisure time PA.</measure>
    <time_frame>Pretest, posttest (6 weeks) and follow-up (6 months)</time_frame>
    <description>Change in amount of total, light and moderate-to-vigorous PA well as total work-related, transport-related, household-related and leisure time PA will be measured via the International Physical Activity Questionnaire (IPAQ). The IPAQ measures physical activity in four domains: work, transport, household and leisure time. Higher scores indicate higher levels of physical activity. For each scale the minimum value is 0. We will use the method described by Dubuy et al. (2013) to truncate the data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-reported sedentary behaviour</measure>
    <time_frame>Pretest, posttest (6 weeks) and follow-up (6 months)</time_frame>
    <description>Change in amount of total sitting time, measured via the LASA sedentary behaviour self-report questionnaire. The total score is calculated by summing all 10 items.The minimum value is 0 and the maximum value is 24 hours. However, data will be truncated at 16 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in self-efficacy</measure>
    <time_frame>Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)</time_frame>
    <description>Change in amount of self-efficacy to change behaviour, measured via 5 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the five items will be considered the final score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in outcome expectancies</measure>
    <time_frame>Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months</time_frame>
    <description>Outcome expectancies regarding the behaviour change, measured via 5 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the five items will be considered the final score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in risk perception</measure>
    <time_frame>Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months</time_frame>
    <description>Risk perception about the behaviour, measured via 4 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the four items will be considered the final score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in intention</measure>
    <time_frame>Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months</time_frame>
    <description>Amount of intention to change the behaviour, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in action planning</measure>
    <time_frame>Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months</time_frame>
    <description>Amount of action planning for behaviour change, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in coping planning</measure>
    <time_frame>Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months</time_frame>
    <description>Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the e- and mHealth intervention 'MyPlan 2.0'.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting List control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will not receive the e- and mHealth intervention 'MyPlan 2.0', but will be given access to the intervention after all testing phases.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MyPlan 2.0</intervention_name>
    <description>MyPlan 2.0 consists of five sessions. During these five sessions the following behaviour change techniques are used to motivate users to be more physically active or to sit less: exploring risk perceptions and perceived benefits, exploring social support, providing feedback, action planning, coping planning and monitoring.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Waiting List</intervention_name>
    <description>Waiting List control group</description>
    <arm_group_label>Waiting List control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have access to internet&#xD;
&#xD;
          -  Being computer literate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non Dutch speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ilse De Bourdeaudhuij</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Geert Crombez</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Movement and Sports Sciences</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>December 3, 2021</last_update_submitted>
  <last_update_submitted_qc>December 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>sedentary behaviour</keyword>
  <keyword>eHealth</keyword>
  <keyword>mHealth</keyword>
  <keyword>self-regulation</keyword>
  <keyword>behaviour change techniques</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <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/NCT03799146
org study id: MyPlan2.0_older_adults_50
nct id: NCT03799146
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate whether and how 'MyPlan 2.0' helps older adults to be
      more physically active or less sedentary. Two groups will be created, an intervention group
      and a waiting-list control group.
The aim of this study is to investigate whether and how 'MyPlan 2.0' helps older adults to be
      more physically active or less sedentary. Two groups will be created, an intervention group
      and a waiting-list control group. Both groups will be tested during three testing waves:
      pretest, posttest and follow-up test. Only the intervention group will be given acces to
      'MyPlan 2.0'.

      'MyPlan 2.0' consists of a website and mobile application targeting physical activity and
      sedentary behaviour. The intervention has a duration of five weeks.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial with two groups: intervention group and waiting-list control group
primary purpose: Treatment
masking: None (Open Label)
measure: Change in objective total, light and moderate-to-vigorous physical activity (PA)
time frame: Pretest, posttest (6 weeks) and follow-up (6 months)
description: Change in amount of total, light and moderate-to-vigorous physical activity, measured via accelerometers
measure: Change in objective sedentary behaviour
time frame: Pretest, posttest (6 weeks) and follow-up (6 months)
description: Change in amount of total sitting time, measured via accelerometers
measure: Change in self-reported total, moderate and moderate-to-vigorous physical activity (PA) as well as total work-related, transport-related, household-related and leisure time PA.
time frame: Pretest, posttest (6 weeks) and follow-up (6 months)
description: Change in amount of total, light and moderate-to-vigorous PA well as total work-related, transport-related, household-related and leisure time PA will be measured via the International Physical Activity Questionnaire (IPAQ). The IPAQ measures physical activity in four domains: work, transport, household and leisure time. Higher scores indicate higher levels of physical activity. For each scale the minimum value is 0. We will use the method described by Dubuy et al. (2013) to truncate the data.
measure: Change in self-reported sedentary behaviour
time frame: Pretest, posttest (6 weeks) and follow-up (6 months)
description: Change in amount of total sitting time, measured via the LASA sedentary behaviour self-report questionnaire. The total score is calculated by summing all 10 items.The minimum value is 0 and the maximum value is 24 hours. However, data will be truncated at 16 hours.
measure: Change in self-efficacy
time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
description: Change in amount of self-efficacy to change behaviour, measured via 5 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the five items will be considered the final score.
measure: Change in outcome expectancies
time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
description: Outcome expectancies regarding the behaviour change, measured via 5 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the five items will be considered the final score.
measure: Change in risk perception
time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
description: Risk perception about the behaviour, measured via 4 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the four items will be considered the final score
measure: Change in intention
time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
description: Amount of intention to change the behaviour, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score.
measure: Change in action planning
time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
description: Amount of action planning for behaviour change, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score.
measure: Change in coping planning
time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
description: Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score.
arm group label: Intervention group
arm group type: Experimental
description: Participants will receive the e- and mHealth intervention 'MyPlan 2.0'.
arm group label: Waiting List control group
arm group type: Experimental
description: Participants will not receive the e- and mHealth intervention 'MyPlan 2.0', but will be given access to the intervention after all testing phases.
intervention type: Behavioral
intervention name: MyPlan 2.0
description: MyPlan 2.0 consists of five sessions. During these five sessions the following behaviour change techniques are used to motivate users to be more physically active or to sit less: exploring risk perceptions and perceived benefits, exploring social support, providing feedback, action planning, coping planning and monitoring.
arm group label: Intervention group
intervention type: Other
intervention name: Waiting List
description: Waiting List control group
arm group label: Waiting List control group
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ilse De Bourdeaudhuij
role: Principal Investigator
affiliation: University Ghent
last name: Geert Crombez
role: Principal Investigator
affiliation: University Ghent
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Overweight
sharing ipd: No