<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/NCT03783611</url>
  </required_header>
  <id_info>
    <org_study_id>MyPlan2.0._olderadults</org_study_id>
    <nct_id>NCT03783611</nct_id>
  </id_info>
  <brief_title>Effectiveness of MyPlan 2.0. in Older Adults</brief_title>
  <official_title>Testing the Effectiveness of MyPlan 2.0. on Physical Activity 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 beneficial effects of physical activity (PA) for older adults are well known. Yet, few&#xD;
      older adults reach the health guideline of 150 minutes/week of moderate-intensity PA. eHealth&#xD;
      interventions are effective in raising PA levels in older adults on the short-term. However,&#xD;
      intermediate- or long-term effects have been examined rarely. This study aimed to investigate&#xD;
      the effect of the eHealth intervention 'MyPlan 2.0' on both accelerometer-based and&#xD;
      self-reported PA levels in Belgian older adults on the short- and intermediate-term.&#xD;
&#xD;
      This study was a randomized controlled trial with three measurement moments (baseline (n=72),&#xD;
      post (five weeks after baseline; n=68) and follow-up (three months after baseline; n=68). At&#xD;
      all measurement moments, participants in the control group and intervention group filled out&#xD;
      the International Physical Activity Questionnaire and wore an accelerometer during one week.&#xD;
      Participants in the intervention group got access to the eHealth intervention 'MyPlan 2.0'&#xD;
      and used it for five consecutive weeks after baseline. 'MyPlan 2.0' was based on&#xD;
      self-regulatory theory and focused on both pre- and post-intentional processes to increase&#xD;
      PA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Technical information about the content of the MyPlan 2.0. intervention:&#xD;
&#xD;
      MyPlan 2.0. was the eHealth intervention that was used in this study. MyPlan 2.0. is a&#xD;
      theory- and user-based intervention. Theories used to develop the intervention are the&#xD;
      self-regulation theory and the Health Action Approach model. The intervention targets pre-&#xD;
      and post-intentional processes to reach behavior change. The intervention consists of five&#xD;
      website visits in five weeks (one per week).&#xD;
&#xD;
      During the first website visit, the participants fill in a short PA questionnaire and based&#xD;
      on the answers, they receive personal feedback about their behavior (pre-intentional&#xD;
      processes). Knowledge is also provided by giving users the chance to fill in an optional quiz&#xD;
      about PA and its beneficial effects. Post-intentional processes are targeted during this&#xD;
      first visit by asking the participants to make an action plan. Participants are asked what&#xD;
      they want to do (e.g. being more active by cycling during leisure time), when (e.g. every&#xD;
      Sunday morning), where (e.g. in the streets nearby) and for how long (e.g. 60 minutes). After&#xD;
      answering these questions, the participants can identify difficult situations and possible&#xD;
      barriers (i.e. coping planning) while pursuing their goals. Dependent on which barriers they&#xD;
      select, specific solutions are given and the participants could choose which ones they&#xD;
      consider appropriate and want to apply. After this first website visit, the users can&#xD;
      indicate how they want to self-monitor their behaviour (e.g. using an agenda).&#xD;
&#xD;
      One week after finishing the first website visit, the participants receive an email to&#xD;
      revisit the website. During this second visit, they receive feedback about their behavioural&#xD;
      change process and their goals (e.g. did the participant reach his/her goal or not?).&#xD;
      Afterwards the participants have the possibility to adapt their action plan (e.g. setting&#xD;
      new, more realistic goals). They can reconsider coping plans, based on barriers they&#xD;
      experienced while pursuing their goals. Furthermore, participants can optionally read&#xD;
      activity tips. Website visits 3, 4 and 5 are respectively activated one week after the&#xD;
      previous visit. Again, the participants are reminded by email. These three last visits are&#xD;
      identical to the second visit (review of the action and coping plan).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 7, 2016</start_date>
  <completion_date type="Actual">June 16, 2017</completion_date>
  <primary_completion_date type="Actual">June 16, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in accelerometer-based physical activity</measure>
    <time_frame>change between baseline and post (5 weeks after baseline)</time_frame>
    <description>participants wear an accelerometer (activity monitor) to objectively measure their physical activity levels. The investigators examine change in total physical activity (sum of light- intensity and moderate-to-vigorous physical activity) and moderate-to-vigorous physical activity. Higher values represent more physical activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in accelerometer-based physical activity</measure>
    <time_frame>change between baseline and follow-up (3 months after baseline)</time_frame>
    <description>participants wear an accelerometer (activity monitor) to objectively measure their physical activity levels. The investigators examine change in total physical activity (sum of light-intensity and moderate-to-vigorous physical activity) and moderate-to-vigorous physical activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in self-reported physical activity</measure>
    <time_frame>change between baseline and post (5 weeks after baseline)</time_frame>
    <description>the validated International Physical Activity Questionnaire (IPAQ) is used to assess self-reported weekly physical activity in three domains (leisure-time, transport, household). Within each domain, different intensities and types of physical activity are assessed. Minutes per week of physical activity in all subdomains are assessed, namely leisure-time walking, leisure-time moderate physical activity, leisure-time vigorous physical activity, moderate physical activity in the garden, vigorous physical activity in the garden, moderate physical activity at home, walking for transport and cycling for transport. The physical activity data are truncated to realistic maxima based on the official IPAQ guidelines. These guidelines subscribe that the maximum amount of physical activity for each subdomain is maximum 840 minutes per week.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in self-reported physical activity</measure>
    <time_frame>change between baseline and follow-up (3 months after baseline)</time_frame>
    <description>the validated International Physical Activity Questionnaire (IPAQ) is used to assess self-reported weekly physical activity in three domains (leisure-time, transport, household). Within each domain, different types and intensities of physical activity are assessed. Minutes per week of physical activity in all subdomains are assessed, namely leisure-time walking, leisure-time moderate physical activity, leisure-time vigorous physical activity, moderate physical activity in the garden, vigorous physical activity in the garden, moderate physical activity at home, walking for transport and cycling for transport. The physical activity data are truncated to realistic maxima based on the official IPAQ guidelines. These guidelines subscribe that the maximum amount of physical activity for each subdomain is maximum 840 minutes per week.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Physical Activity</condition>
  <condition>Older Adults</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group has access to the MyPlan 2.0. eHealth intervention. MyPlan is a eHealth intervention designed to increase physical activity. The intervention is based on the self-regulation theory and focuses on pre- and post-intentional processes to increase physical activity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group receives no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MyPlan 2.0.</intervention_name>
    <description>eHealth intervention to increase physical activity in older adults. MyPlan 2.0 consists of five website visits. The first website visit contains pre- and post-intentional processes. The following four website visits contains mainly post-intentional processes. During the first website, participants fill in a questionnaire about their physical activity levels, and receive feedback. Furthermore, they are asked to make an action plan and think about barriers to reach their activity goals and possible solutions to tackle these barriers. During the other four website visits, participants receive feedback about their behavior change process and their action plan (did they reach their goal)? During these website visits, they can adapt their action plans.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  retired&#xD;
&#xD;
          -  able to walk 100 meters without assistance&#xD;
&#xD;
          -  speak and understand Dutch&#xD;
&#xD;
          -  have an email address&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe physical health problems&#xD;
&#xD;
          -  not retired&#xD;
&#xD;
          -  not able to speak and understand Dutch&#xD;
&#xD;
          -  not having an email address&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Greet Cardon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>May 14, 2019</last_update_submitted>
  <last_update_submitted_qc>May 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Ghent</investigator_affiliation>
    <investigator_full_name>Vakgroepsport</investigator_full_name>
    <investigator_title>Department of Movement and Sports Sciences</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>only researchers of our own research group will have access to the full data of the participants, only for research purposes. Only anonymized data will be shared with other researchers of our own research group.&#xD;
other researchers can obtain research information upon request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>the data will be available when the study is finished (June 2017) and will be available for ten years.</ipd_time_frame>
    <ipd_access_criteria>the data will be stored on the Ghent University share system that can be accessed with a personal log in and password</ipd_access_criteria>
  </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/NCT03783611
org study id: MyPlan2.0._olderadults
nct id: NCT03783611
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The beneficial effects of physical activity (PA) for older adults are well known. Yet, few
      older adults reach the health guideline of 150 minutes/week of moderate-intensity PA. eHealth
      interventions are effective in raising PA levels in older adults on the short-term. However,
      intermediate- or long-term effects have been examined rarely. This study aimed to investigate
      the effect of the eHealth intervention 'MyPlan 2.0' on both accelerometer-based and
      self-reported PA levels in Belgian older adults on the short- and intermediate-term.

      This study was a randomized controlled trial with three measurement moments (baseline (n=72),
      post (five weeks after baseline; n=68) and follow-up (three months after baseline; n=68). At
      all measurement moments, participants in the control group and intervention group filled out
      the International Physical Activity Questionnaire and wore an accelerometer during one week.
      Participants in the intervention group got access to the eHealth intervention 'MyPlan 2.0'
      and used it for five consecutive weeks after baseline. 'MyPlan 2.0' was based on
      self-regulatory theory and focused on both pre- and post-intentional processes to increase
      PA.
Technical information about the content of the MyPlan 2.0. intervention:

      MyPlan 2.0. was the eHealth intervention that was used in this study. MyPlan 2.0. is a
      theory- and user-based intervention. Theories used to develop the intervention are the
      self-regulation theory and the Health Action Approach model. The intervention targets pre-
      and post-intentional processes to reach behavior change. The intervention consists of five
      website visits in five weeks (one per week).

      During the first website visit, the participants fill in a short PA questionnaire and based
      on the answers, they receive personal feedback about their behavior (pre-intentional
      processes). Knowledge is also provided by giving users the chance to fill in an optional quiz
      about PA and its beneficial effects. Post-intentional processes are targeted during this
      first visit by asking the participants to make an action plan. Participants are asked what
      they want to do (e.g. being more active by cycling during leisure time), when (e.g. every
      Sunday morning), where (e.g. in the streets nearby) and for how long (e.g. 60 minutes). After
      answering these questions, the participants can identify difficult situations and possible
      barriers (i.e. coping planning) while pursuing their goals. Dependent on which barriers they
      select, specific solutions are given and the participants could choose which ones they
      consider appropriate and want to apply. After this first website visit, the users can
      indicate how they want to self-monitor their behaviour (e.g. using an agenda).

      One week after finishing the first website visit, the participants receive an email to
      revisit the website. During this second visit, they receive feedback about their behavioural
      change process and their goals (e.g. did the participant reach his/her goal or not?).
      Afterwards the participants have the possibility to adapt their action plan (e.g. setting
      new, more realistic goals). They can reconsider coping plans, based on barriers they
      experienced while pursuing their goals. Furthermore, participants can optionally read
      activity tips. Website visits 3, 4 and 5 are respectively activated one week after the
      previous visit. Again, the participants are reminded by email. These three last visits are
      identical to the second visit (review of the action and coping plan).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: change in accelerometer-based physical activity
time frame: change between baseline and post (5 weeks after baseline)
description: participants wear an accelerometer (activity monitor) to objectively measure their physical activity levels. The investigators examine change in total physical activity (sum of light- intensity and moderate-to-vigorous physical activity) and moderate-to-vigorous physical activity. Higher values represent more physical activity.
measure: change in accelerometer-based physical activity
time frame: change between baseline and follow-up (3 months after baseline)
description: participants wear an accelerometer (activity monitor) to objectively measure their physical activity levels. The investigators examine change in total physical activity (sum of light-intensity and moderate-to-vigorous physical activity) and moderate-to-vigorous physical activity.
measure: change in self-reported physical activity
time frame: change between baseline and post (5 weeks after baseline)
description: the validated International Physical Activity Questionnaire (IPAQ) is used to assess self-reported weekly physical activity in three domains (leisure-time, transport, household). Within each domain, different intensities and types of physical activity are assessed. Minutes per week of physical activity in all subdomains are assessed, namely leisure-time walking, leisure-time moderate physical activity, leisure-time vigorous physical activity, moderate physical activity in the garden, vigorous physical activity in the garden, moderate physical activity at home, walking for transport and cycling for transport. The physical activity data are truncated to realistic maxima based on the official IPAQ guidelines. These guidelines subscribe that the maximum amount of physical activity for each subdomain is maximum 840 minutes per week.
measure: change in self-reported physical activity
time frame: change between baseline and follow-up (3 months after baseline)
description: the validated International Physical Activity Questionnaire (IPAQ) is used to assess self-reported weekly physical activity in three domains (leisure-time, transport, household). Within each domain, different types and intensities of physical activity are assessed. Minutes per week of physical activity in all subdomains are assessed, namely leisure-time walking, leisure-time moderate physical activity, leisure-time vigorous physical activity, moderate physical activity in the garden, vigorous physical activity in the garden, moderate physical activity at home, walking for transport and cycling for transport. The physical activity data are truncated to realistic maxima based on the official IPAQ guidelines. These guidelines subscribe that the maximum amount of physical activity for each subdomain is maximum 840 minutes per week.
arm group label: Intervention group
arm group type: Experimental
description: The intervention group has access to the MyPlan 2.0. eHealth intervention. MyPlan is a eHealth intervention designed to increase physical activity. The intervention is based on the self-regulation theory and focuses on pre- and post-intentional processes to increase physical activity.
arm group label: control group
arm group type: No Intervention
description: The control group receives no intervention
intervention type: Behavioral
intervention name: MyPlan 2.0.
description: eHealth intervention to increase physical activity in older adults. MyPlan 2.0 consists of five website visits. The first website visit contains pre- and post-intentional processes. The following four website visits contains mainly post-intentional processes. During the first website, participants fill in a questionnaire about their physical activity levels, and receive feedback. Furthermore, they are asked to make an action plan and think about barriers to reach their activity goals and possible solutions to tackle these barriers. During the other four website visits, participants receive feedback about their behavior change process and their action plan (did they reach their goal)? During these website visits, they can adapt their action plans.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 65 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Greet Cardon, PhD
role: Principal Investigator
affiliation: University Ghent
responsible party type: Principal Investigator
investigator affiliation: University Ghent
investigator full name: Vakgroepsport
investigator title: Department of Movement and Sports Sciences
sharing ipd: Yes
ipd description: only researchers of our own research group will have access to the full data of the participants, only for research purposes. Only anonymized data will be shared with other researchers of our own research group.
other researchers can obtain research information upon request
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: the data will be available when the study is finished (June 2017) and will be available for ten years.
ipd access criteria: the data will be stored on the Ghent University share system that can be accessed with a personal log in and password