<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/NCT03286374</url>
  </required_header>
  <id_info>
    <org_study_id>2017/573</org_study_id>
    <nct_id>NCT03286374</nct_id>
  </id_info>
  <brief_title>Do Change in Life Style Improve Work Ability?</brief_title>
  <official_title>Do Change in Life Style Improve Work Ability? A Controlled Study of the Effect of Changes in Lifestyle on Work Participation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Molde University College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Volda University College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Molde University College</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 main aim of this Cohort trial is to get more information about how life style changes&#xD;
      affect work participation for people with BMI above 30. The information can contribute to&#xD;
      improving the quality of occupational rehabilitation programs in the specialized health care&#xD;
      services and for others who work with weight loss programs and work related rehabilitation&#xD;
      programs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of rehabilitation, in general, is to help people to reach and maintain their optimal&#xD;
      function and copying capabilities and to promote independence and participation in society.&#xD;
      For occupational rehabilitation is the goal also to increase function and work ability to&#xD;
      prevent the individuals permanent to fall out of working life. People with high BMI needs&#xD;
      beside work rehabilitation also focus on life style changes to reduce consequences of&#xD;
      obesity. The Central Norway Regional Health Authority (HMN RHF) has initiated action to&#xD;
      reduce work absence and consequence of obesity by introducing a work related rehabilitation&#xD;
      program for people with BMI above 30. This program combines work participation and life style&#xD;
      changes and exists only in two institutions in Norway. The goal of the program is to increase&#xD;
      function and work ability and weight loss. The program is new, and few documents exist on the&#xD;
      effect and the correlation between life style changes and work ability. There is also need to&#xD;
      question whether obesity is the reason for work absence or is there other factors that affect&#xD;
      work ability. This trial wants to follow-up a group of people who have been participating&#xD;
      occupational rehabilitation at Muritunet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Actual">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">August 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The study is a Clinical cohort trial with a pseudo prospective, parallel mixed methods design. Questionnaires and register data at baseline, T1, and T2. Focus group interviews at T3, and register data at T4.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Due to the nature of the study intervention, it is not possible to blind the participants. Some of the participants will give a focus group interview and their identity will be known for the other participants in the group. The health care providers will not get information about who will participate or not.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Work participation</measure>
    <time_frame>1-4 years</time_frame>
    <description>Work participation after a work related rehabilitation program at Muritunet.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Life quality</measure>
    <time_frame>Survey data collected at baseline, six and twelve months after participation in the trial.</time_frame>
    <description>Quality of life; health - 15D ( Harri Sintonen, http://www.15d-instrument.net)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work motivation</measure>
    <time_frame>Survey data collected at baseline, six and twelve months after participation in the trial.</time_frame>
    <description>Return to work self-efficacy, Return-to-work self-efficacy scale (RTWSE-19) (Shaw et al. 2011)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight loss</measure>
    <time_frame>Weight collected at baseline, six and twelve months after participation in the trial.</time_frame>
    <description>Weight changing</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Obesity, Morbid</condition>
  <condition>Sick-leave</condition>
  <condition>Work Related Illnesses</condition>
  <condition>Life Style</condition>
  <arm_group>
    <arm_group_label>Occupational rehabilitation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The participants will receive the current occupational rehabilitation program at Muritunet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Occupational rehabilitation</intervention_name>
    <description>The participants in the occupational rehabilitation program get both practical and theoretical intervention in groups. Four main interventions; cognitive therapy, physical activity, diets and training in work-oriented approach. The rehabilitation stay is as followed:&#xD;
Four weeks with an institutional stay at Muritunet (BL)&#xD;
Follow-up;&#xD;
Eight weeks, telephone contact between therapist at Muritunet and the participant.&#xD;
16 weeks, video conference on SKYPE between all the participants and a therapist. Lecture on diets.&#xD;
28 weeks, Follow-up at Muritunet. Central themes that day is education, conversation, physical test, and forms. (T1)&#xD;
40 weeks, telephone contact between therapist at Muritunet and the participant.&#xD;
52 weeks, Follow-up at Muritunet. Central themes that day is education, conversation, physical test, and forms. (T2)</description>
    <arm_group_label>Occupational rehabilitation</arm_group_label>
    <other_name>Life style treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. People who are on sick leave or stands in danger of being sick because of problems&#xD;
             related to obesity.&#xD;
&#xD;
          2. The participants must have a realistic opportunity to return to work.&#xD;
&#xD;
          3. Body mass index above 30&#xD;
&#xD;
          4. Age 18-67 years.&#xD;
&#xD;
        Exclusion criteria;&#xD;
&#xD;
          1. People with a severe eating disorder.&#xD;
&#xD;
          2. People without a capacity to consent.&#xD;
&#xD;
          3. People with severe alcohol and/or drug abuse.&#xD;
&#xD;
          4. People with a major mental illness.&#xD;
&#xD;
          5. Being pregnant.&#xD;
&#xD;
          6. People with a health condition that contraindicates physical activity.&#xD;
&#xD;
          7. People who receive work assessment allowance.&#xD;
&#xD;
          8. People with or plan to apply for disability benefits.&#xD;
&#xD;
          9. People with permanently adapted work.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Odd Ragnar Hunnes, Dean</last_name>
    <role>Study Director</role>
    <affiliation>Volda University Collage</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anita Dyb Linge</name>
      <address>
        <city>Valldal</city>
        <state>Møre Og Romsdal</state>
        <zip>6210</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>October 22, 2020</last_update_submitted>
  <last_update_submitted_qc>October 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Molde University College</investigator_affiliation>
    <investigator_full_name>Anita Dyb Linge</investigator_full_name>
    <investigator_title>Ph.D Student</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Occupational rehabilitation</keyword>
  <keyword>Sick leave</keyword>
  <keyword>Life style treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03286374/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03286374
org study id: 2017/573
nct id: NCT03286374
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main aim of this Cohort trial is to get more information about how life style changes
      affect work participation for people with BMI above 30. The information can contribute to
      improving the quality of occupational rehabilitation programs in the specialized health care
      services and for others who work with weight loss programs and work related rehabilitation
      programs.
The goal of rehabilitation, in general, is to help people to reach and maintain their optimal
      function and copying capabilities and to promote independence and participation in society.
      For occupational rehabilitation is the goal also to increase function and work ability to
      prevent the individuals permanent to fall out of working life. People with high BMI needs
      beside work rehabilitation also focus on life style changes to reduce consequences of
      obesity. The Central Norway Regional Health Authority (HMN RHF) has initiated action to
      reduce work absence and consequence of obesity by introducing a work related rehabilitation
      program for people with BMI above 30. This program combines work participation and life style
      changes and exists only in two institutions in Norway. The goal of the program is to increase
      function and work ability and weight loss. The program is new, and few documents exist on the
      effect and the correlation between life style changes and work ability. There is also need to
      question whether obesity is the reason for work absence or is there other factors that affect
      work ability. This trial wants to follow-up a group of people who have been participating
      occupational rehabilitation at Muritunet.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The study is a Clinical cohort trial with a pseudo prospective, parallel mixed methods design. Questionnaires and register data at baseline, T1, and T2. Focus group interviews at T3, and register data at T4.
primary purpose: Health Services Research
masking: None (Open Label)
masking description: Due to the nature of the study intervention, it is not possible to blind the participants. Some of the participants will give a focus group interview and their identity will be known for the other participants in the group. The health care providers will not get information about who will participate or not.
measure: Work participation
time frame: 1-4 years
description: Work participation after a work related rehabilitation program at Muritunet.
measure: Life quality
time frame: Survey data collected at baseline, six and twelve months after participation in the trial.
description: Quality of life; health - 15D ( Harri Sintonen, http://www.15d-instrument.net)
measure: Work motivation
time frame: Survey data collected at baseline, six and twelve months after participation in the trial.
description: Return to work self-efficacy, Return-to-work self-efficacy scale (RTWSE-19) (Shaw et al. 2011)
measure: Weight loss
time frame: Weight collected at baseline, six and twelve months after participation in the trial.
description: Weight changing
arm group label: Occupational rehabilitation
arm group type: Other
description: The participants will receive the current occupational rehabilitation program at Muritunet.
intervention type: Behavioral
intervention name: Occupational rehabilitation
description: The participants in the occupational rehabilitation program get both practical and theoretical intervention in groups. Four main interventions; cognitive therapy, physical activity, diets and training in work-oriented approach. The rehabilitation stay is as followed:
Four weeks with an institutional stay at Muritunet (BL)
Follow-up;
Eight weeks, telephone contact between therapist at Muritunet and the participant.
16 weeks, video conference on SKYPE between all the participants and a therapist. Lecture on diets.
28 weeks, Follow-up at Muritunet. Central themes that day is education, conversation, physical test, and forms. (T1)
40 weeks, telephone contact between therapist at Muritunet and the participant.
52 weeks, Follow-up at Muritunet. Central themes that day is education, conversation, physical test, and forms. (T2)
arm group label: Occupational rehabilitation
other name: Life style treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 67 Years
healthy volunteers: No
last name: Odd Ragnar Hunnes, Dean
role: Study Director
affiliation: Volda University Collage
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Molde University College
investigator full name: Anita Dyb Linge
investigator title: Ph.D Student
mesh term: Obesity, Morbid
sharing ipd: No
provided document: 