<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/NCT03274271</url>
  </required_header>
  <id_info>
    <org_study_id>MyPlan2.0</org_study_id>
    <nct_id>NCT03274271</nct_id>
  </id_info>
  <brief_title>Efficacy of Different Behaviour Change Techniques in MyPlan 2.0</brief_title>
  <official_title>A Parallel-group Randomized Trial to Compare the Efficacy of Different Behaviour Change Techniques in the e- and M-health Intervention 'MyPlan 2.0'</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 the effectiveness of intervention 'MyPlan 2.0' and&#xD;
      the efficacy of the different behaviour change techniques that are included. Eight groups&#xD;
      will be created that will receive a different version of the intervention, varying in three&#xD;
      behaviour change techniques (action planning, coping planning, self-monitoring).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The effectiveness of the self-regulation-based e- and m-health intervention 'MyPlan 2.0' on&#xD;
      changing physical activity and sedentary behaviour in the adult population will be&#xD;
      investigated. Furthermore, the role of three different behaviour change techniques (action&#xD;
      planning, coping planning, self-monitoring) will be examined via a 2x2x2 design, in which 8&#xD;
      groups are created that all receive a different version of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 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>Factorial Assignment</intervention_model>
    <intervention_model_description>2x2x2 design with 3 behaviour change techiques provided or not provided</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The different participants will receive different website links to the intervention website, according to their group. The link will not provide information about their group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in objective physical activity (PA)</measure>
    <time_frame>Baseline, 5 weeks, 3 months, 1 year</time_frame>
    <description>Change in amount of total physical activity and moderate-to-vigorous physical activity, measured via accelerometers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in objective sedentary behaviour</measure>
    <time_frame>Baseline, 5 weeks, 3 months, 1 year</time_frame>
    <description>Change in amount of total sitting time, measured via accelerometers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-reported physical activity (PA)</measure>
    <time_frame>Baseline, 5 weeks, 3 months, 1 year</time_frame>
    <description>Change in amount of total physical activity 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>Baseline, 5 weeks, 3 months, 1 year</time_frame>
    <description>Change in amount of total sitting time, measured via the last 7-days sedentary behaviour self-report questionnaire (SIT-Q-7d)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in self-efficacy</measure>
    <time_frame>Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year</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 motivation</measure>
    <time_frame>Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year</time_frame>
    <description>Change in amount of motivation to change behaviour, measured via 3 validated items (questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in outcome expectancies</measure>
    <time_frame>Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year</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>Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year</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>Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year</time_frame>
    <description>Amount of intention to change behaviour, measured via 3 validated items (questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in action planning</measure>
    <time_frame>Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year</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>Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year</time_frame>
    <description>Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire)</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Disease, Chronic</condition>
  <arm_group>
    <arm_group_label>AP+CP+M</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with all three behaviour change techniques of interest: action planning (AP), coping planning (CP) and self-monitoring (M).&#xD;
They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AP+CP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with two of the behaviour change techniques of interest: action planning (AP) and coping planning (CP).&#xD;
They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AP+M</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with two of the behaviour change techniques of interest: action planning (AP) and self-monitoring (M).&#xD;
They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CP+M</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with two of the behaviour change techniques of interest: coping planning (CP) and self-monitoring (M).&#xD;
They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>M</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with only one of the behaviour change techniques of interest: self-monitoring (M).&#xD;
They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with only one of the behaviour change techniques of interest: coping planning (CP).&#xD;
They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with only one of the behaviour change techniques of interest: action planning (AP).&#xD;
They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive the e- and mHealth intervention 'MyPlan 2.0' without the three behaviour change techniques of interest (action planning, coping planning, self-monitoring). They will receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Action planning</intervention_name>
    <description>Action planning is the behaviour change technique used to make users specify their goal (what they are going to do, when, where, ...).</description>
    <arm_group_label>AP</arm_group_label>
    <arm_group_label>AP+CP</arm_group_label>
    <arm_group_label>AP+CP+M</arm_group_label>
    <arm_group_label>AP+M</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Coping planning</intervention_name>
    <description>Coping planning is the behaviour change technique used to make users think about possible hindrances and according solutions when trying to reach their goal.</description>
    <arm_group_label>AP+CP</arm_group_label>
    <arm_group_label>AP+CP+M</arm_group_label>
    <arm_group_label>CP</arm_group_label>
    <arm_group_label>CP+M</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-monitoring</intervention_name>
    <description>Self-monitoring is the behaviour change technique used to make users keep track of their goal.</description>
    <arm_group_label>AP+CP+M</arm_group_label>
    <arm_group_label>AP+M</arm_group_label>
    <arm_group_label>CP+M</arm_group_label>
    <arm_group_label>M</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Feedback and tips</intervention_name>
    <description>In this intervention, users receive tailored feedback on their current health behaviour and tips and tricks to reach their goals. This tips and tricks include the behaviour change technique 'eliciting social support'.</description>
    <arm_group_label>AP</arm_group_label>
    <arm_group_label>AP+CP</arm_group_label>
    <arm_group_label>AP+CP+M</arm_group_label>
    <arm_group_label>AP+M</arm_group_label>
    <arm_group_label>CP</arm_group_label>
    <arm_group_label>CP+M</arm_group_label>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>M</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - 18 years old or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not Dutch-speaking&#xD;
&#xD;
          -  Does not own a smartphone&#xD;
&#xD;
          -  Does not have access to the internet&#xD;
&#xD;
          -  Is not able to be physically active/non-sedentary&#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>
  <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>University Ghent</name>
      <address>
        <city>Ghent</city>
        <state>East-Flanders</state>
        <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>June 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 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>eHealth</keyword>
  <keyword>mHealth</keyword>
  <keyword>self-regulation</keyword>
  <keyword>behaviour change techniques</keyword>
  <keyword>action planning</keyword>
  <keyword>coping planning</keyword>
  <keyword>self-monitoring</keyword>
  <keyword>prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03274271
org study id: MyPlan2.0
nct id: NCT03274271
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the effectiveness of intervention 'MyPlan 2.0' and
      the efficacy of the different behaviour change techniques that are included. Eight groups
      will be created that will receive a different version of the intervention, varying in three
      behaviour change techniques (action planning, coping planning, self-monitoring).
The effectiveness of the self-regulation-based e- and m-health intervention 'MyPlan 2.0' on
      changing physical activity and sedentary behaviour in the adult population will be
      investigated. Furthermore, the role of three different behaviour change techniques (action
      planning, coping planning, self-monitoring) will be examined via a 2x2x2 design, in which 8
      groups are created that all receive a different version of the intervention.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: 2x2x2 design with 3 behaviour change techiques provided or not provided
primary purpose: Prevention
masking: Single (Participant)
masking description: The different participants will receive different website links to the intervention website, according to their group. The link will not provide information about their group.
measure: Change in objective physical activity (PA)
time frame: Baseline, 5 weeks, 3 months, 1 year
description: Change in amount of total physical activity and moderate-to-vigorous physical activity, measured via accelerometers
measure: Change in objective sedentary behaviour
time frame: Baseline, 5 weeks, 3 months, 1 year
description: Change in amount of total sitting time, measured via accelerometers
measure: Change in self-reported physical activity (PA)
time frame: Baseline, 5 weeks, 3 months, 1 year
description: Change in amount of total physical activity and moderate-to-vigorous physical activity, measured via the International Physical Activity Questionnaire (IPAQ)
measure: Change in self-reported sedentary behaviour
time frame: Baseline, 5 weeks, 3 months, 1 year
description: Change in amount of total sitting time, measured via the last 7-days sedentary behaviour self-report questionnaire (SIT-Q-7d)
measure: Change in self-efficacy
time frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
description: Change in amount of self-efficacy to change behaviour, measured via 3 validated items (questionnaire)
measure: Change in motivation
time frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
description: Change in amount of motivation to change behaviour, measured via 3 validated items (questionnaire)
measure: Change in outcome expectancies
time frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
description: Outcome expectancies regarding the behaviour change, measured via 3 validated items (questionnaire)
measure: Change in risk perception
time frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
description: Risk perception about the behaviour, measured via 3 validated items (questionnaire)
measure: Change in intention
time frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
description: Amount of intention to change behaviour, measured via 3 validated items (questionnaire)
measure: Change in action planning
time frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
description: Amount of action planning for behaviour change, measured via 3 validated items (questionnaire)
measure: Change in coping planning
time frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
description: Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire)
arm group label: AP+CP+M
arm group type: Experimental
description: Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with all three behaviour change techniques of interest: action planning (AP), coping planning (CP) and self-monitoring (M).
They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.
arm group label: AP+CP
arm group type: Experimental
description: Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with two of the behaviour change techniques of interest: action planning (AP) and coping planning (CP).
They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.
arm group label: AP+M
arm group type: Experimental
description: Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with two of the behaviour change techniques of interest: action planning (AP) and self-monitoring (M).
They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.
arm group label: CP+M
arm group type: Experimental
description: Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with two of the behaviour change techniques of interest: coping planning (CP) and self-monitoring (M).
They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.
arm group label: M
arm group type: Experimental
description: Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with only one of the behaviour change techniques of interest: self-monitoring (M).
They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.
arm group label: CP
arm group type: Experimental
description: Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with only one of the behaviour change techniques of interest: coping planning (CP).
They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.
arm group label: AP
arm group type: Experimental
description: Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with only one of the behaviour change techniques of interest: action planning (AP).
They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.
arm group label: Control
arm group type: Active Comparator
description: Participants will receive the e- and mHealth intervention 'MyPlan 2.0' without the three behaviour change techniques of interest (action planning, coping planning, self-monitoring). They will receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.
intervention type: Behavioral
intervention name: Action planning
description: Action planning is the behaviour change technique used to make users specify their goal (what they are going to do, when, where, ...).
arm group label: AP
arm group label: AP+CP
arm group label: AP+CP+M
arm group label: AP+M
intervention type: Behavioral
intervention name: Coping planning
description: Coping planning is the behaviour change technique used to make users think about possible hindrances and according solutions when trying to reach their goal.
arm group label: AP+CP
arm group label: AP+CP+M
arm group label: CP
arm group label: CP+M
intervention type: Behavioral
intervention name: Self-monitoring
description: Self-monitoring is the behaviour change technique used to make users keep track of their goal.
arm group label: AP+CP+M
arm group label: AP+M
arm group label: CP+M
arm group label: M
intervention type: Behavioral
intervention name: Feedback and tips
description: In this intervention, users receive tailored feedback on their current health behaviour and tips and tricks to reach their goals. This tips and tricks include the behaviour change technique 'eliciting social support'.
arm group label: AP
arm group label: AP+CP
arm group label: AP+CP+M
arm group label: AP+M
arm group label: CP
arm group label: CP+M
arm group label: Control
arm group label: M
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
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: Chronic Disease
sharing ipd: No