<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/NCT01675687</url>
  </required_header>
  <id_info>
    <org_study_id>EK-12-098-VK ID by EC Vienna</org_study_id>
    <nct_id>NCT01675687</nct_id>
  </id_info>
  <brief_title>Web Based Follow up Intervention in Obesity Treatment for Women</brief_title>
  <official_title>Effects on Self-efficacy, Sustainability and Drop Out Rate Using Web Based Follow up Intervention in Obesity Treatment for Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FEM Süd</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>FEM Süd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to verify that web based follow up intervention after a classic&#xD;
      multidisciplinary face-to-face obesity treatment will reinforced nutrition and exercise&#xD;
      self-efficacy, improve drop out rate and advance sustainability after weight loss of obese&#xD;
      women.&#xD;
&#xD;
      Research Questions and Hypotheses&#xD;
&#xD;
        -  How does a web based follow up intervention change self-efficacy of women participating&#xD;
           in an obesity intervention?&#xD;
&#xD;
        -  How does a web based follow up intervention affect the drop out rate of women&#xD;
           participating in an obesity intervention?&#xD;
&#xD;
        -  How does a web based follow up intervention influence sustainability of women&#xD;
           participating in an obesity intervention?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in nutrition- and exercise self-efficacy</measure>
    <time_frame>Primary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)</time_frame>
    <description>Changes in nutrition- and exercise self-efficacy will be measured by scores in questionnaires for nutrition- and exercise self-efficacy (Sportbezogene Selbstwirksamkeitserwartung - Fuchs &amp; Schwarzer, 1994 and Weight Efficacy Life-Style Questionnaire - Clark et al. 1991). A change of more than one standard deviation will be considered significant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dropout rate</measure>
    <time_frame>Secondary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)</time_frame>
    <description>The Dropout rate will be compared by the number of women available for the last meeting at the end of the follw up intervention.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sustainability of weight loss</measure>
    <time_frame>Further outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)</time_frame>
    <description>Sustainability will be measured in&#xD;
percentage of women successfully stabilized weight (range of ± 2 kg based on Cooper et al. (2008)&#xD;
percentage of women keeping the scores or impair no more than 1 standard deviation in their test results (&quot;Ad Eva Testsystem zur Diagnostik und Evaluation bei Adipositas&quot; - Ardelt-Gattinger und Meindl, 2009; &quot;Sportbezogene Selbstwirksamkeitserwartung&quot; - Fuchs &amp; Schwarzer, 1994; &quot;Weight Efficacy Life-Style Questionnaire (WEL)&quot; - Clark et al., 1991; &quot;SF 36 - Fragebogen zum Gesundheitszustand&quot; - Bullinger und Kirchberger, 1998)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Internet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants of this intervention group get follow up support via Internet.&#xD;
They have access to new inputs biweekly consisting of&#xD;
Thematic inputs and instructions (e.g. advice on shopping, cooking, regular exercise on daily routine, motivation and more)&#xD;
assignments promoting self-awareness and introspection&#xD;
spreadsheets promoting self-monitoring&#xD;
News and updates (e.g. recipes, gymnastic classes, meetings of self support groups and more) will be available each month.&#xD;
Tailored feedback of their behaviour will be given by documentation on spreadsheets.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Printed Manual</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants of this intervention group get follow up support via a printed manual.&#xD;
The manual consist of all the same inputs as are available to the Internet follow up group.&#xD;
Thematic inputs and instructions (e.g. advice on shopping, cooking, regular exercise on daily routine, motivation and more)&#xD;
assignments promoting self-awareness and introspection&#xD;
spreadsheets promoting self-monitoring&#xD;
All inputs will be given at once at the beginning of the follow up intervention, only news and updates (e.g. recipes, gymnastic classes, meetings of self support groups and more) will be sent per mail each month.&#xD;
There is no tailored feedback of their behaviour as the paper-pencil documentation on spreadsheets can't be monitored by the psychologists.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Follow Up Support</intervention_name>
    <description>inputs will be based on elements derived from cognitive behavioural therapy, acceptance and commitment therapy, mindfulness and awareness training</description>
    <arm_group_label>Internet</arm_group_label>
    <arm_group_label>Printed Manual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  Age 18-80&#xD;
&#xD;
          -  BMI 30-40&#xD;
&#xD;
          -  Internet access&#xD;
&#xD;
          -  Motivation and psychological stability to stay in a long term obesity intervention&#xD;
&#xD;
          -  No medical conditions prohibiting moderate physical exercise&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men&#xD;
&#xD;
          -  Age under 18 years&#xD;
&#xD;
          -  BMI under 30 and above 40&#xD;
&#xD;
          -  No Internet access&#xD;
&#xD;
          -  No motivation and psychological stability to stay in a long term obesity intervention&#xD;
&#xD;
          -  Medical conditions prohibiting moderate physical exercise&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sonja Rader, Mag.a</last_name>
    <role>Principal Investigator</role>
    <affiliation>FEM Süd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>FEM Süd</name>
      <address>
        <city>Vienna</city>
        <zip>1100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <link>
    <url>http://www.rundum-gsund.at</url>
    <description>Homepage of the project (German)</description>
  </link>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>March 6, 2015</last_update_submitted>
  <last_update_submitted_qc>March 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dietary habits and obesity</keyword>
  <keyword>exercise habits and obesity</keyword>
  <keyword>cognition and obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <!-- 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/NCT01675687
org study id: EK-12-098-VK ID by EC Vienna
nct id: NCT01675687
lead sponsor: 
has dmc: No
This study is designed to verify that web based follow up intervention after a classic
      multidisciplinary face-to-face obesity treatment will reinforced nutrition and exercise
      self-efficacy, improve drop out rate and advance sustainability after weight loss of obese
      women.

      Research Questions and Hypotheses

        -  How does a web based follow up intervention change self-efficacy of women participating
           in an obesity intervention?

        -  How does a web based follow up intervention affect the drop out rate of women
           participating in an obesity intervention?

        -  How does a web based follow up intervention influence sustainability of women
           participating in an obesity intervention?
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in nutrition- and exercise self-efficacy
time frame: Primary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
description: Changes in nutrition- and exercise self-efficacy will be measured by scores in questionnaires for nutrition- and exercise self-efficacy (Sportbezogene Selbstwirksamkeitserwartung - Fuchs & Schwarzer, 1994 and Weight Efficacy Life-Style Questionnaire - Clark et al. 1991). A change of more than one standard deviation will be considered significant.
measure: Dropout rate
time frame: Secondary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
description: The Dropout rate will be compared by the number of women available for the last meeting at the end of the follw up intervention.
measure: Sustainability of weight loss
time frame: Further outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
description: Sustainability will be measured in
percentage of women successfully stabilized weight (range of ± 2 kg based on Cooper et al. (2008)
percentage of women keeping the scores or impair no more than 1 standard deviation in their test results ("Ad Eva Testsystem zur Diagnostik und Evaluation bei Adipositas" - Ardelt-Gattinger und Meindl, 2009; "Sportbezogene Selbstwirksamkeitserwartung" - Fuchs & Schwarzer, 1994; "Weight Efficacy Life-Style Questionnaire (WEL)" - Clark et al., 1991; "SF 36 - Fragebogen zum Gesundheitszustand" - Bullinger und Kirchberger, 1998)
arm group label: Internet
arm group type: Experimental
description: Participants of this intervention group get follow up support via Internet.
They have access to new inputs biweekly consisting of
Thematic inputs and instructions (e.g. advice on shopping, cooking, regular exercise on daily routine, motivation and more)
assignments promoting self-awareness and introspection
spreadsheets promoting self-monitoring
News and updates (e.g. recipes, gymnastic classes, meetings of self support groups and more) will be available each month.
Tailored feedback of their behaviour will be given by documentation on spreadsheets.
arm group label: Printed Manual
arm group type: Experimental
description: Participants of this intervention group get follow up support via a printed manual.
The manual consist of all the same inputs as are available to the Internet follow up group.
Thematic inputs and instructions (e.g. advice on shopping, cooking, regular exercise on daily routine, motivation and more)
assignments promoting self-awareness and introspection
spreadsheets promoting self-monitoring
All inputs will be given at once at the beginning of the follow up intervention, only news and updates (e.g. recipes, gymnastic classes, meetings of self support groups and more) will be sent per mail each month.
There is no tailored feedback of their behaviour as the paper-pencil documentation on spreadsheets can't be monitored by the psychologists.
intervention type: Behavioral
intervention name: Follow Up Support
description: inputs will be based on elements derived from cognitive behavioural therapy, acceptance and commitment therapy, mindfulness and awareness training
arm group label: Internet
arm group label: Printed Manual
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sonja Rader, Mag.a
role: Principal Investigator
affiliation: FEM Süd
facility: 
country: Austria
url: http://www.rundum-gsund.at
description: Homepage of the project (German)
responsible party type: Sponsor
mesh term: Obesity