<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/NCT03807323</url>
  </required_header>
  <id_info>
    <org_study_id>2017-1100</org_study_id>
    <nct_id>NCT03807323</nct_id>
  </id_info>
  <brief_title>Tools for Lasting Lifestyle Changes</brief_title>
  <acronym>TLC</acronym>
  <official_title>New Tools for Lasting Lifestyle Changes Among Inactive Obese People at Risk of Cardiovascular Disease (TLC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Tromso</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Tromso</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>
      Pilot and feasibility study; a complex intervention focusing on lifestyle change to increase&#xD;
      physical activity and reduce cardiovascular disease (CVD) risk among high risk individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interdisciplinary, mixed-method, prospective and single-arm exploratory study aimed to&#xD;
      explore study feasibility, responsiveness, participants adherence and adverse events among&#xD;
      the participants before deciding to proceed to full-scale evaluation.&#xD;
&#xD;
      Enrollment of max. 20 obese people (BMI&gt;30) with sedentary lifestyle and increased CVD-risk&#xD;
      (NORRISK2)..&#xD;
&#xD;
      Participants general health status including cardiopulmonary fitness will be assessed both&#xD;
      before and after the intervention (blood pressure, ECG, spirometry, treadmill tests VO2max,&#xD;
      blood tests, body composition by Dual-energy X-ray absorptiometry (DEXA) measurements)&#xD;
      Participants´ functional capacity assessed by several range of motion tests. Participants&#xD;
      nutritional and psychological status assessed by validated questionnaires.&#xD;
&#xD;
      Several blood-tests and ECG will be recorded at three months.&#xD;
&#xD;
      Daily activity level during and six months after the intervention period monitored by Polar&#xD;
      M430 pulse watch.&#xD;
&#xD;
      The participants will be interviewed with focus on their prior health, activity habits and&#xD;
      intervention experiences at three months and six months after end of the intervention. Two&#xD;
      focus-group interviews at end of intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">October 4, 2018</completion_date>
  <primary_completion_date type="Actual">October 4, 2018</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>Feasibility study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline physical activity at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Change from baseline steps counted by activity trackers (Polar M430) at 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline central obesity at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Change from baseline waist circumference (cm) at 6 months standardized measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline VO2max at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Change from baseline VO2max at 6 months measured on treadmill test</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Lifestyle Risk Reduction</condition>
  <arm_group>
    <arm_group_label>'Lifestyle counselling and exercise' .</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study is a single-arm study where all participants undergo the same intervention 'Lifestyle counselling and exercise' .</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle counselling and exercise</intervention_name>
    <description>The program consists of:&#xD;
Instructor-led training twice a week,&#xD;
One individual nutritionist counselling session of followed by three group based two-hour nutritionist counselling focusing on practical food purchase and preparation and&#xD;
Three two-hour psychologist-led group counselling sessions based on implementation intentions theory and practical help to make if-then plans focusing on changing food and activity habits.</description>
    <arm_group_label>'Lifestyle counselling and exercise' .</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 55-74 years&#xD;
&#xD;
          2. BMI&gt; 30&#xD;
&#xD;
          3. Moderate elevated NORRISK 2 score&#xD;
&#xD;
          4. Motivation for lifestyle change&#xD;
&#xD;
          5. Has agreed to attend and participate in a student study during the study period&#xD;
&#xD;
        Exclusion criteria: 1.External disease with short life expectancy 2.Diseases that limit&#xD;
        physical activity in the project 3.Serious mental illness 4. Previous myocardial infarction&#xD;
        5.EKG changes that show severe rhythm disturbance, unstable angina or heart attack&#xD;
&#xD;
        5.EKG changes that show severe rhythm disturbance, unstable angina or heart attack:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sameline Grimsgaard, MD, MPH, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UiT the Arctic University of Norway</name>
      <address>
        <city>Tromsø</city>
        <zip>9037</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Primary intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT03807323
org study id: 2017-1100
nct id: NCT03807323
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pilot and feasibility study; a complex intervention focusing on lifestyle change to increase
      physical activity and reduce cardiovascular disease (CVD) risk among high risk individuals.
Interdisciplinary, mixed-method, prospective and single-arm exploratory study aimed to
      explore study feasibility, responsiveness, participants adherence and adverse events among
      the participants before deciding to proceed to full-scale evaluation.

      Enrollment of max. 20 obese people (BMI>30) with sedentary lifestyle and increased CVD-risk
      (NORRISK2)..

      Participants general health status including cardiopulmonary fitness will be assessed both
      before and after the intervention (blood pressure, ECG, spirometry, treadmill tests VO2max,
      blood tests, body composition by Dual-energy X-ray absorptiometry (DEXA) measurements)
      Participants´ functional capacity assessed by several range of motion tests. Participants
      nutritional and psychological status assessed by validated questionnaires.

      Several blood-tests and ECG will be recorded at three months.

      Daily activity level during and six months after the intervention period monitored by Polar
      M430 pulse watch.

      The participants will be interviewed with focus on their prior health, activity habits and
      intervention experiences at three months and six months after end of the intervention. Two
      focus-group interviews at end of intervention.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Feasibility study
primary purpose: Prevention
masking: None (Open Label)
measure: Change from baseline physical activity at 6 months
time frame: 6 months
description: Change from baseline steps counted by activity trackers (Polar M430) at 6 months
measure: Change from baseline central obesity at 6 months
time frame: 6 months
description: Change from baseline waist circumference (cm) at 6 months standardized measured
measure: Change from baseline VO2max at 6 months
time frame: 6 months
description: Change from baseline VO2max at 6 months measured on treadmill test
arm group label: 'Lifestyle counselling and exercise' .
arm group type: Experimental
description: The study is a single-arm study where all participants undergo the same intervention 'Lifestyle counselling and exercise' .
intervention type: Behavioral
intervention name: Lifestyle counselling and exercise
description: The program consists of:
Instructor-led training twice a week,
One individual nutritionist counselling session of followed by three group based two-hour nutritionist counselling focusing on practical food purchase and preparation and
Three two-hour psychologist-led group counselling sessions based on implementation intentions theory and practical help to make if-then plans focusing on changing food and activity habits.
arm group label: 'Lifestyle counselling and exercise' .
criteria: 
gender: All
minimum age: 55 Years
maximum age: 75 Years
healthy volunteers: No
last name: Sameline Grimsgaard, MD, MPH, PhD
role: Principal Investigator
affiliation: Professor
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: No