<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/NCT03291171</url>
  </required_header>
  <id_info>
    <org_study_id>MyPlan2.0_diabetes</org_study_id>
    <nct_id>NCT03291171</nct_id>
  </id_info>
  <brief_title>Identifying the Effect and Working Mechanisms of MyPlan 2.0 in Adults With Type 2 Diabetes</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 Adults With Type 2 Diabetes.</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 adults with type 2&#xD;
      diabetes to be more physically active or less sedentary. Two groups will be created, an&#xD;
      intervention group 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 adults with type 2&#xD;
      diabetes to be more physically active or less sedentary. Two groups will be created, an&#xD;
      intervention group and a waiting-list control group. Both groups will be tested during three&#xD;
      testing waves: pretest, posttest and follow-up test. Only the intervention group will be&#xD;
      given acces to 'MyPlan 2.0'. 'MyPlan 2.0' consists of a website and mobile application&#xD;
      targeting physical activity and sedentary behaviour. The intervention has a duration of five&#xD;
      weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2017</start_date>
  <completion_date type="Actual">March 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 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>
    <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, 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 the International Physical Activity Questionnaire (IPAQ)</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</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 3 validated items (questionnaire)</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 3 validated items (questionnaire)</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 3 validated items (questionnaire)</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)</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)</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)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Chronic Disease</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>No Intervention</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>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Type 2 diabetes&#xD;
&#xD;
          -  Have access to internet&#xD;
&#xD;
          -  Being computer literate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not Dutch Speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ilse De Bourdeaudhuij, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Geert Crombez, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maïté Verloigne, PostDoc</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>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</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>type 2 diabetes</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>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Chronic Disease</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/NCT03291171
org study id: MyPlan2.0_diabetes
nct id: NCT03291171
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 adults with type 2
      diabetes 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 adults with type 2
      diabetes 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, 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 the International Physical Activity Questionnaire (IPAQ)
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
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 3 validated items (questionnaire)
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 3 validated items (questionnaire)
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 3 validated items (questionnaire)
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)
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)
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)
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: No Intervention
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
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ilse De Bourdeaudhuij, Professor
role: Principal Investigator
affiliation: University Ghent
last name: Geert Crombez, Professor
role: Principal Investigator
affiliation: University Ghent
last name: Maïté Verloigne, PostDoc
role: Principal Investigator
affiliation: University Ghent
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Chronic Disease
sharing ipd: No