<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/NCT04425304</url>
  </required_header>
  <id_info>
    <org_study_id>Resepti-Onnikka</org_study_id>
    <nct_id>NCT04425304</nct_id>
  </id_info>
  <brief_title>Effects of Efficient Lifestyle Counseling Method on the Risks of Cardiovascular Disease in Health Care Center Patients</brief_title>
  <official_title>The Effects of an Efficient Lifestyle Counseling Method on the Risks of Cardiovascular Disease in Health Care Center Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oulu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oulu</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 aim of the trial is to study the effect of a lifestyle change program in patients with&#xD;
      obesity and risk of cardiovascular diseases. The main focus is to motivate and support&#xD;
      lifestyle changes.&#xD;
&#xD;
      Two different group counseling methods (intensive and standard) with or without internet&#xD;
      support will be compared. Thus, the patients will be randomized into four arms. Patients will&#xD;
      be recruited from local general practice teams. The intensive lifestyle counseling consists&#xD;
      of 12 group counseling sessions and 2 personal counseling sessions. The standard counseling&#xD;
      consists of 4 group sessions. The internet-based counseling contains aspects of cognitive&#xD;
      behavior therapy and persuasive design system and consists of weekly reminders, tasks,&#xD;
      self-monitoring, and reflection.&#xD;
&#xD;
      The main outcome is the decrease in body weight. Secondary outcomes are changes in eating&#xD;
      behavior, eating habits, components of metabolic syndrome (waist circumference, plasma lipid&#xD;
      and glucose values), and calculated scores of cardiometabolic condition, cardiovascular risk&#xD;
      and adiposity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 2, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2024</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>Baseline to 2 years</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Group counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group counseling + persuasive ICT support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intensive group counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intensive group counseling + persuasive ICT support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group counseling</intervention_name>
    <description>4 times</description>
    <arm_group_label>Group counseling</arm_group_label>
    <arm_group_label>Group counseling + persuasive ICT support</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensive group counseling</intervention_name>
    <description>14 times</description>
    <arm_group_label>Intensive group counseling</arm_group_label>
    <arm_group_label>Intensive group counseling + persuasive ICT support</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Persuasive ICT support</intervention_name>
    <description>Weekly reminders for 12 months</description>
    <arm_group_label>Group counseling + persuasive ICT support</arm_group_label>
    <arm_group_label>Intensive group counseling + persuasive ICT support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index 30 to 40 kg/m2&#xD;
&#xD;
          -  + 2 risk factors of cardiovascular diseases:&#xD;
&#xD;
               -  Elevated blood pressure or hypertension&#xD;
&#xD;
               -  High LDL or hypocholesterolemic drug&#xD;
&#xD;
               -  Low HDL or hypocholesterolemic drug&#xD;
&#xD;
               -  Elevated triglyceride value or hypolipidemic drug&#xD;
&#xD;
               -  Elevated glucose value or diabetes medication&#xD;
&#xD;
               -  Smoking&#xD;
&#xD;
          -  Access to email and internet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Untreated hypothyroidism&#xD;
&#xD;
          -  Oral corticosteroid treatment&#xD;
&#xD;
          -  Pregnancy and lactation&#xD;
&#xD;
          -  Angina pectoris&#xD;
&#xD;
          -  Cardiac insufficiency&#xD;
&#xD;
          -  Coronary Heart Disease&#xD;
&#xD;
          -  Inability to speak Finnish&#xD;
&#xD;
          -  Anticipated lack of compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janne Hukkanen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oulu, Oulu University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oulu University Hospital</name>
      <address>
        <city>Oulu</city>
        <zip>90029 OYS</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oulu</investigator_affiliation>
    <investigator_full_name>Janne Hukkanen</investigator_full_name>
    <investigator_title>Professor of Internal Medicine</investigator_title>
  </responsible_party>
  <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/NCT04425304
org study id: Resepti-Onnikka
nct id: NCT04425304
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the trial is to study the effect of a lifestyle change program in patients with
      obesity and risk of cardiovascular diseases. The main focus is to motivate and support
      lifestyle changes.

      Two different group counseling methods (intensive and standard) with or without internet
      support will be compared. Thus, the patients will be randomized into four arms. Patients will
      be recruited from local general practice teams. The intensive lifestyle counseling consists
      of 12 group counseling sessions and 2 personal counseling sessions. The standard counseling
      consists of 4 group sessions. The internet-based counseling contains aspects of cognitive
      behavior therapy and persuasive design system and consists of weekly reminders, tasks,
      self-monitoring, and reflection.

      The main outcome is the decrease in body weight. Secondary outcomes are changes in eating
      behavior, eating habits, components of metabolic syndrome (waist circumference, plasma lipid
      and glucose values), and calculated scores of cardiometabolic condition, cardiovascular risk
      and adiposity.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in body weight
time frame: Baseline to 2 years
arm group label: Group counseling
arm group type: Active Comparator
arm group label: Group counseling + persuasive ICT support
arm group type: Experimental
arm group label: Intensive group counseling
arm group type: Active Comparator
arm group label: Intensive group counseling + persuasive ICT support
arm group type: Experimental
intervention type: Behavioral
intervention name: Group counseling
description: 4 times
arm group label: Group counseling
arm group label: Group counseling + persuasive ICT support
intervention type: Behavioral
intervention name: Intensive group counseling
description: 14 times
arm group label: Intensive group counseling
arm group label: Intensive group counseling + persuasive ICT support
intervention type: Behavioral
intervention name: Persuasive ICT support
description: Weekly reminders for 12 months
arm group label: Group counseling + persuasive ICT support
arm group label: Intensive group counseling + persuasive ICT support
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: Janne Hukkanen, MD, PhD
role: Principal Investigator
affiliation: University of Oulu, Oulu University Hospital
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: University of Oulu
investigator full name: Janne Hukkanen
investigator title: Professor of Internal Medicine
mesh term: Cardiovascular Diseases
sharing ipd: No