<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/NCT03026296</url>
  </required_header>
  <id_info>
    <org_study_id>2016/546-1</org_study_id>
    <nct_id>NCT03026296</nct_id>
  </id_info>
  <brief_title>Healthy Life Centers - Municipal Health Care Service for Lifestyle Changes - a Multicenter Intervention Study</brief_title>
  <official_title>Healthy Life Centers - Municipal Health Care Service for Lifestyle Changes - a Multicenter Intervention Study on Changes Among Participants and Moderators for Changes Such as the Centers Capacity and Competence and the Participants Motivation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Western Norway University of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</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>
      A Healthy Life Center (HLC, 'Frisklivssentrale') is a public community-based health service&#xD;
      providing lifestyle support programs for physical activity, smoking cessation and diet, to&#xD;
      inhabitants with increased risk for development of non-communicable diseases. HLCs intention&#xD;
      is to reach physically inactive people who need guidance to get more physically active, and&#xD;
      offer them a lifestyle program for three months or more.&#xD;
&#xD;
      The main aim of this study is to study whether the HLCs, organized according to the Norwegian&#xD;
      Directorate of Health's guidelines for municipal healthy life centers, affects the&#xD;
      participants short term (3 months) and long term (15 months) physical activity level. Also&#xD;
      changes in diet, tobacco use, health related quality of life, physical fitness,&#xD;
      anthropometry, self-efficacy, motivation, drug use, use of health services and work&#xD;
      participation will be assessed. Secondary aim is to study whether there are any moderators,&#xD;
      such as HLCs capacity, expertise, and collaboration with other services, that have&#xD;
      significance for participants' change. Also it will be studied whether the HLCs result in&#xD;
      larger changes in some subgroups (e.g. socioeconomic) of participants than in others.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>physical activity</measure>
    <time_frame>change from baseline to 3 months</time_frame>
    <description>measured by accelerometer (ActiGraph GT3X+) for seven consecutive days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>physical activity</measure>
    <time_frame>change from 3 months to 15 months</time_frame>
    <description>measured by accelerometer (ActiGraph GT3X+) for seven consecutive days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>change from baseline to 3 months</time_frame>
    <description>assessed by questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>change from 3 months to 15 months</time_frame>
    <description>assessed by questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>health related quality of life</measure>
    <time_frame>change from baseline to 3 months</time_frame>
    <description>assessed by SF-36 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>health related quality of life</measure>
    <time_frame>change from 3 months to 15 months</time_frame>
    <description>assessed by SF-36 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet</measure>
    <time_frame>change from baseline to 3 months</time_frame>
    <description>assessed by questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet</measure>
    <time_frame>change from 3 months to 15 months</time_frame>
    <description>assessed by questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tobacco use</measure>
    <time_frame>change from baseline to 3 months</time_frame>
    <description>assessed by questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tobacco use</measure>
    <time_frame>change from 3 months to 15 months</time_frame>
    <description>assessed by questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical fitness</measure>
    <time_frame>change from baseline to 3 months</time_frame>
    <description>assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical fitness</measure>
    <time_frame>change from 3 months to 15 months</time_frame>
    <description>assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>change from baseline to 3 months</time_frame>
    <description>measured on a scale digital weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>change from 3 months to 15 months</time_frame>
    <description>measured on a scale digital weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>change from baseline to 3 months</time_frame>
    <description>body height measured by a Seca altimeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>change from 3 months to 15 months</time_frame>
    <description>body height measured by a Seca altimeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>change from baseline to 3 months</time_frame>
    <description>measured by Seca measurement tape</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>change from 3 months to 15 months</time_frame>
    <description>measured by Seca measurement tape</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip circumference</measure>
    <time_frame>change from baseline to 3 months</time_frame>
    <description>measured by Seca measurement tape</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip circumference</measure>
    <time_frame>change from 3 months to 15 months</time_frame>
    <description>measured by Seca measurement tape</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1022</enrollment>
  <condition>Musculoskeletal Disease</condition>
  <condition>Obesity</condition>
  <condition>Psychological Disorder</condition>
  <arm_group>
    <arm_group_label>Participators in HLCs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adults with high risk of non-communicable diseases (musculoskeletal disease, obesity, physical distress) about to start a 3 months structural support for lifestyle change in a Healthy Life Center (HLC) in Norway</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Life Center</intervention_name>
    <description>Depending on what behavior participants aim to change, they get individual counselling using elements from motivational interviewing, group-based exercise twice a week, diet courses and tobacco secession courses during three months</description>
    <arm_group_label>Participators in HLCs</arm_group_label>
    <other_name>Frisklivssentralen (Norwegian)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  about to start structural support for lifestyle change (regarding physical activity,&#xD;
             diet and/or tobacco cessation&#xD;
&#xD;
          -  referred to a Healthy Life Center (HLC) from either primary physician, from other&#xD;
             health care services or social services, or participants seeking contact themselves&#xD;
             without a specific referral.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having participated in an HLC the previous 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Riina Kiik, phd</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Erik Kyrkjebø, phd</last_name>
    <role>Study Director</role>
    <affiliation>Western Norway University of Applied Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Frisklivssentrale</name>
      <address>
        <city>Drammen (plus 9 More Communities)</city>
        <state>Buskerud County</state>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frisklivssentrale</name>
      <address>
        <city>Levanger (plus 4 More Communities)</city>
        <state>Nord-Trøndelag County</state>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frisklivssentrale</name>
      <address>
        <city>Bodo (plus 11 More Communities)</city>
        <state>Nordland County</state>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frisklivssentrale</name>
      <address>
        <city>Laerdal (plus 6 More Communities)</city>
        <state>Sogn Og Fjordane County</state>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>https://helsedirektoratet.no/folkehelse/frisklivssentraler</url>
    <description>Helsedirektoratet Frisklivssentraler</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>February 26, 2020</last_update_submitted>
  <last_update_submitted_qc>February 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical Fitness</keyword>
  <keyword>Health Status</keyword>
  <keyword>Exercise</keyword>
  <keyword>Tobacco Use Cessation</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Healthy Diet</keyword>
  <keyword>Health Promotion</keyword>
  <keyword>Patient Education as Topic</keyword>
  <keyword>Counseling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</mesh_term>
    <mesh_term>Mental Disorders</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/NCT03026296
org study id: 2016/546-1
nct id: NCT03026296
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A Healthy Life Center (HLC, 'Frisklivssentrale') is a public community-based health service
      providing lifestyle support programs for physical activity, smoking cessation and diet, to
      inhabitants with increased risk for development of non-communicable diseases. HLCs intention
      is to reach physically inactive people who need guidance to get more physically active, and
      offer them a lifestyle program for three months or more.

      The main aim of this study is to study whether the HLCs, organized according to the Norwegian
      Directorate of Health's guidelines for municipal healthy life centers, affects the
      participants short term (3 months) and long term (15 months) physical activity level. Also
      changes in diet, tobacco use, health related quality of life, physical fitness,
      anthropometry, self-efficacy, motivation, drug use, use of health services and work
      participation will be assessed. Secondary aim is to study whether there are any moderators,
      such as HLCs capacity, expertise, and collaboration with other services, that have
      significance for participants' change. Also it will be studied whether the HLCs result in
      larger changes in some subgroups (e.g. socioeconomic) of participants than in others.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: physical activity
time frame: change from baseline to 3 months
description: measured by accelerometer (ActiGraph GT3X+) for seven consecutive days
measure: physical activity
time frame: change from 3 months to 15 months
description: measured by accelerometer (ActiGraph GT3X+) for seven consecutive days
measure: Physical activity
time frame: change from baseline to 3 months
description: assessed by questionnaire
measure: Physical activity
time frame: change from 3 months to 15 months
description: assessed by questionnaire
measure: health related quality of life
time frame: change from baseline to 3 months
description: assessed by SF-36 questionnaire
measure: health related quality of life
time frame: change from 3 months to 15 months
description: assessed by SF-36 questionnaire
measure: Diet
time frame: change from baseline to 3 months
description: assessed by questionnaire
measure: Diet
time frame: change from 3 months to 15 months
description: assessed by questionnaire
measure: Tobacco use
time frame: change from baseline to 3 months
description: assessed by questionnaire
measure: Tobacco use
time frame: change from 3 months to 15 months
description: assessed by questionnaire
measure: Physical fitness
time frame: change from baseline to 3 months
description: assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill
measure: Physical fitness
time frame: change from 3 months to 15 months
description: assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill
measure: Body weight
time frame: change from baseline to 3 months
description: measured on a scale digital weight
measure: Body weight
time frame: change from 3 months to 15 months
description: measured on a scale digital weight
measure: Body Mass Index
time frame: change from baseline to 3 months
description: body height measured by a Seca altimeter
measure: Body Mass Index
time frame: change from 3 months to 15 months
description: body height measured by a Seca altimeter
measure: Waist circumference
time frame: change from baseline to 3 months
description: measured by Seca measurement tape
measure: Waist circumference
time frame: change from 3 months to 15 months
description: measured by Seca measurement tape
measure: Hip circumference
time frame: change from baseline to 3 months
description: measured by Seca measurement tape
measure: Hip circumference
time frame: change from 3 months to 15 months
description: measured by Seca measurement tape
arm group label: Participators in HLCs
arm group type: Experimental
description: Adults with high risk of non-communicable diseases (musculoskeletal disease, obesity, physical distress) about to start a 3 months structural support for lifestyle change in a Healthy Life Center (HLC) in Norway
intervention type: Behavioral
intervention name: Healthy Life Center
description: Depending on what behavior participants aim to change, they get individual counselling using elements from motivational interviewing, group-based exercise twice a week, diet courses and tobacco secession courses during three months
arm group label: Participators in HLCs
other name: Frisklivssentralen (Norwegian)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Riina Kiik, phd
role: Study Director
affiliation: Norwegian University of Science and Technology
last name: Erik Kyrkjebø, phd
role: Study Director
affiliation: Western Norway University of Applied Sciences
facility: 
facility: 
facility: 
facility: 
country: Norway
url: https://helsedirektoratet.no/folkehelse/frisklivssentraler
description: Helsedirektoratet Frisklivssentraler
responsible party type: Sponsor
mesh term: Musculoskeletal Diseases
mesh term: Mental Disorders
sharing ipd: No