<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/NCT02211040</url>
  </required_header>
  <id_info>
    <org_study_id>BE670201421382</org_study_id>
    <nct_id>NCT02211040</nct_id>
  </id_info>
  <brief_title>eHealth Intervention to Promote Self-regulation of Physical Activity and Fruit and Vegetable Intake Among Adults Who Visit General Practice</brief_title>
  <official_title>Effect Evaluation of an eHealth Intervention to Promote Self-regulation of Physical Activity and Fruit and Vegetable Intake Among Adults in General Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Welfare, Public Health and Family, Flemish government, Belgium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Ghent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators have developed an eHealth intervention based on self-regulation for the&#xD;
      promotion of self-regulation of physical activity and fruit and vegetable intake among adults&#xD;
      who visit general practice. Effectiveness of the intervention will be evaluated in a&#xD;
      three-arm clustered quasi-experimental design in general practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To increase effect sizes and reach of computer tailored interventions, the theory of&#xD;
      self-regulation was used, motivational and volitional determinants were targeted and the&#xD;
      intervention was not served as a stand-alone intervention but was delivered in general&#xD;
      practice. The intervention consists of three sessions for each behaviour (ie., physical&#xD;
      activity, fruit and vegetables intake) and is available on a website and tablets to deliver&#xD;
      it in general practice. Adults can start session one on a tablet in general practice or on&#xD;
      their own computer at home, after receiving a flyer in general practice. In this first&#xD;
      session adults receive general information, monitor their behaviour and receive tailored&#xD;
      feedback to increase awareness. Adults are also guided to set goals and self-efficacy is&#xD;
      increased by modeling and problem solving methods. In the second and third session, adults&#xD;
      can evaluate if they reached their goals, make coping plans and adapt their action plans. To&#xD;
      ensure the feasibility of implementing the intervention in general practice, general&#xD;
      practitioners were involved from the beginning of the development.&#xD;
&#xD;
      A three-arm clustered quasi-experimental design will be used to evaluate the effectiveness of&#xD;
      the intervention. Therefore, general practitioners will be recruited and patients will be&#xD;
      randomly assigned at general practice level. Within each practice, patients can be allocated&#xD;
      in three groups. Group one is an intervention group in which general practitioners select and&#xD;
      motivate adults to use the intervention. In group two, the selection and motivation of adults&#xD;
      will be conducted by a researcher in the waiting room and finally, group three will be a&#xD;
      control group in which adults are also selected by a researcher. The distinction between the&#xD;
      two intervention groups is made to evaluate if general practitioners influence when&#xD;
      recruiting participants leads to beneficial effects compared to when investigators recruit&#xD;
      participants. Furthermore, it will also be investigated if the implementation of the&#xD;
      intervention by general practitioners is feasible.&#xD;
&#xD;
      In the intervention groups, adults are asked to complete session one (S1) and measurements&#xD;
      questions on a tablet in general practice or are referred with a flyer to do this at their&#xD;
      computer at home. Adults, who do not use the tablet, have to fill in a short questionnaire&#xD;
      and leave their email address to send them a reminder email to complete session one at home.&#xD;
      In session one, adults choose themselves for which behaviour(s) they want to complete the&#xD;
      intervention. One week (S2) and one month (S3) after session one is completed, adults will&#xD;
      receive an email to respectively start session two and three for the chosen behaviour(s). In&#xD;
      the control group, adults have to fill in a questionnaire at base line in general practice or&#xD;
      at home (C1) and one month post intervention (C2).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>&quot;Change from Baseline in physical activity level at 1 and 6 months&quot;</measure>
    <time_frame>After 1 and 6 months</time_frame>
    <description>Amount of physical activity per day and per week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>&quot;Change from Baseline in fruit and vegetable intake at 1 and 6 months&quot;</measure>
    <time_frame>After 1 and 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>&quot;Change from Baseline in scores on self-regulation skills at 1 and 6 months&quot;</measure>
    <time_frame>After 1 and 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">426</enrollment>
  <condition>Physical Activity</condition>
  <condition>Fruit and Vegetable Intake</condition>
  <condition>Self-regulation</condition>
  <condition>Empowerment</condition>
  <arm_group>
    <arm_group_label>No general practitioner involvement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The selection and motivation of adults will be conducted by a researcher in the waiting room. There is no extra motivation of the general practitioner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General practitioner involvement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An intervention group in which general practitioners select and motivate adults to be more physical active and eat more fruit and vegetables.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>My Plan</intervention_name>
    <description>The intervention consists of three sessions for each behaviour (ie., physical activity, fruit and vegetables intake) and is available on a website and tablets to deliver it in general practice.&#xD;
Adults can start session one on a tablet in general practice or on their own computer at home, after receiving a flyer in general practice.&#xD;
In this first session adults receive general information, monitor their behaviour and receive tailored feedback to increase awareness.&#xD;
Adults are also guided to set goals and self-efficacy is increased by modeling and problem solving methods.&#xD;
In the second and third session, adults can evaluate if they reached their goals, make coping plans and adapt their action plans.</description>
    <arm_group_label>General practitioner involvement</arm_group_label>
    <arm_group_label>No general practitioner involvement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older than 18 years&#xD;
&#xD;
          -  Having access to internet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No access to internet&#xD;
&#xD;
          -  Younger than 18 years&#xD;
&#xD;
          -  Not understanding the Dutch Language&#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>Jolien Plaete</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>
  <link>
    <url>https://steunpuntwvg.be/</url>
    <description>Funding</description>
  </link>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>May 4, 2017</last_update_submitted>
  <last_update_submitted_qc>May 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2017</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>Professor doctor Ilse De Bourdeaudhuij</investigator_title>
  </responsible_party>
  <keyword>Intervention Mapping Protocol</keyword>
  <keyword>physical activity</keyword>
  <keyword>fruit intake</keyword>
  <keyword>vegetable intake</keyword>
  <keyword>computer tailoring</keyword>
  <keyword>eHealth</keyword>
  <keyword>self-regulation</keyword>
  <keyword>goal setting</keyword>
  <keyword>problem solving</keyword>
  <keyword>general practice</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/NCT02211040
org study id: BE670201421382
nct id: NCT02211040
lead sponsor: 
collaborator: 
has dmc: No
The investigators have developed an eHealth intervention based on self-regulation for the
      promotion of self-regulation of physical activity and fruit and vegetable intake among adults
      who visit general practice. Effectiveness of the intervention will be evaluated in a
      three-arm clustered quasi-experimental design in general practice.
To increase effect sizes and reach of computer tailored interventions, the theory of
      self-regulation was used, motivational and volitional determinants were targeted and the
      intervention was not served as a stand-alone intervention but was delivered in general
      practice. The intervention consists of three sessions for each behaviour (ie., physical
      activity, fruit and vegetables intake) and is available on a website and tablets to deliver
      it in general practice. Adults can start session one on a tablet in general practice or on
      their own computer at home, after receiving a flyer in general practice. In this first
      session adults receive general information, monitor their behaviour and receive tailored
      feedback to increase awareness. Adults are also guided to set goals and self-efficacy is
      increased by modeling and problem solving methods. In the second and third session, adults
      can evaluate if they reached their goals, make coping plans and adapt their action plans. To
      ensure the feasibility of implementing the intervention in general practice, general
      practitioners were involved from the beginning of the development.

      A three-arm clustered quasi-experimental design will be used to evaluate the effectiveness of
      the intervention. Therefore, general practitioners will be recruited and patients will be
      randomly assigned at general practice level. Within each practice, patients can be allocated
      in three groups. Group one is an intervention group in which general practitioners select and
      motivate adults to use the intervention. In group two, the selection and motivation of adults
      will be conducted by a researcher in the waiting room and finally, group three will be a
      control group in which adults are also selected by a researcher. The distinction between the
      two intervention groups is made to evaluate if general practitioners influence when
      recruiting participants leads to beneficial effects compared to when investigators recruit
      participants. Furthermore, it will also be investigated if the implementation of the
      intervention by general practitioners is feasible.

      In the intervention groups, adults are asked to complete session one (S1) and measurements
      questions on a tablet in general practice or are referred with a flyer to do this at their
      computer at home. Adults, who do not use the tablet, have to fill in a short questionnaire
      and leave their email address to send them a reminder email to complete session one at home.
      In session one, adults choose themselves for which behaviour(s) they want to complete the
      intervention. One week (S2) and one month (S3) after session one is completed, adults will
      receive an email to respectively start session two and three for the chosen behaviour(s). In
      the control group, adults have to fill in a questionnaire at base line in general practice or
      at home (C1) and one month post intervention (C2).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: "Change from Baseline in physical activity level at 1 and 6 months"
time frame: After 1 and 6 months
description: Amount of physical activity per day and per week
measure: "Change from Baseline in fruit and vegetable intake at 1 and 6 months"
time frame: After 1 and 6 months
measure: "Change from Baseline in scores on self-regulation skills at 1 and 6 months"
time frame: After 1 and 6 months
arm group label: No general practitioner involvement
arm group type: Experimental
description: The selection and motivation of adults will be conducted by a researcher in the waiting room. There is no extra motivation of the general practitioner.
arm group label: General practitioner involvement
arm group type: Experimental
description: An intervention group in which general practitioners select and motivate adults to be more physical active and eat more fruit and vegetables.
intervention type: Behavioral
intervention name: My Plan
description: The intervention consists of three sessions for each behaviour (ie., physical activity, fruit and vegetables intake) and is available on a website and tablets to deliver it in general practice.
Adults can start session one on a tablet in general practice or on their own computer at home, after receiving a flyer in general practice.
In this first session adults receive general information, monitor their behaviour and receive tailored feedback to increase awareness.
Adults are also guided to set goals and self-efficacy is increased by modeling and problem solving methods.
In the second and third session, adults can evaluate if they reached their goals, make coping plans and adapt their action plans.
arm group label: General practitioner involvement
arm group label: No general practitioner involvement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
url: https://steunpuntwvg.be/
description: Funding
responsible party type: Principal Investigator
investigator affiliation: University Ghent
investigator full name: Vakgroepsport
investigator title: Professor doctor Ilse De Bourdeaudhuij