<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/NCT03000062</url>
  </required_header>
  <id_info>
    <org_study_id>MDN01</org_study_id>
    <nct_id>NCT03000062</nct_id>
  </id_info>
  <brief_title>Treatment of Overweight in General Practice</brief_title>
  <official_title>Treatment of Overweight in General Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oslo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the investigators want to explore the feasibility and effect of a simple&#xD;
      intervention provided by primary care physicians on treatment for overweight in general&#xD;
      practice. Regular patients visiting their ordinary family physician will be asked for&#xD;
      participation if they comply with the inclusion criteria. If so, they will follow a detailed&#xD;
      food list for 12 months with regular visits to the doctor. At each visit, the participating&#xD;
      patients will be asked about their progress on weight loss and all measurements will be made.&#xD;
      Simultaneously a control group of primary care physicians will also recruit patients that&#xD;
      fulfill the inclusion criteria. These patients will also provide data that will serve as&#xD;
      Control to the intervention group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The number of patients with overweight is increasing and a daily issue in general practice.&#xD;
      Many patients wish to discuss their weight problem with their family physician but many of&#xD;
      these feel helpless to guide their patients in how to reduce weight. Providing useful and&#xD;
      correct information should not be so difficult but many doctors choose to refer their&#xD;
      patients to dietary courses or follow-up in specialist health care.In this study the&#xD;
      investigators wish to implement a simple tool for treatment of overweight in primary care by&#xD;
      providing the patients a detailed list for all meals that will ensure a weight loss. The&#xD;
      patients will be given a close follow-up by their doctor, and the motivating conversation and&#xD;
      list of meals will be the only treatment given.&#xD;
&#xD;
      The study is a cluster randomised controlled trial where all general practices in the area of&#xD;
      Moss city in Norway will be asked to participate. Half of the physicians will constitute the&#xD;
      intervention group while the other half will serve as control group. Each participating&#xD;
      doctor in both groups will recruit patients according to the eligibility criteria. The&#xD;
      doctors in the intervention group will be provided with a course to learn the intervention&#xD;
      and have a manual to follow for each patient. All participating patients of both groups will&#xD;
      be asked to meet regularly for data collection.&#xD;
&#xD;
      According to the power calculation, a number of 12 physicians in each group will be&#xD;
      sufficient if they recruit 10 patients each.&#xD;
&#xD;
      The intervention will be conducted for 12 months and thereafter data will be continued to be&#xD;
      collected at 6 and 12 months after.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</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>
    <intervention_model_description>Cluster randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>ID of participating patients are only available through the participating Family phyisican</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Weight reduction</measure>
    <time_frame>12 months</time_frame>
    <description>10% weight reduction measured as kilo weight at inclusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>12 months</time_frame>
    <description>Blood pressure measured as mean of three measurements at rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>12 months</time_frame>
    <description>Blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist measure</measure>
    <time_frame>12 months</time_frame>
    <description>Any reduction in cm of waist measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Cholesterol</measure>
    <time_frame>12 months</time_frame>
    <description>Blood samples</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Qualitative study</measure>
    <time_frame>24 months</time_frame>
    <description>Participating physicians and patients will be interviewed about their experiences With the intervention</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Overweight and Obesity</condition>
  <condition>Nutritional and Metabolic Diseases</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 Family physicians in primary care will constitute the Intervention group. They will enroll 10 patients each from their ordinary practice. The physicians will be provided with a specific course on the treatment model of the study, including how to collect and register data. They will have a detailed manual indicating the content of each visit.&#xD;
Following recruitment and consent, the patient will meet for the first visit in the study one week later. At this visit the patient will be provided with detailed information on the content and preparation for all meals. Data will be collected.&#xD;
The manual describes a diet in accordance with official guidelines providing the patient 1600Kcal per day.&#xD;
The following visits will take place after 4 weeks, 8 weeks, 4 months, 8 months and 12 months from the first visit. Data will be collected at all visits, and also at 6 and 12 months follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>12 Family physicians in primary care will constitute the Control group. They will enroll 10 patients each from their ordinary practice. The physicians will not be provided with any information of the treatment model of the study but they will have all information about how to collect and register data.&#xD;
The patients on this group will also sign consent to provide data and therefore they will know about the study but they do not get any specific information about weight loss other than the general information that their physician may tell them.&#xD;
The patients in the Control Group will be asked to give data on inclusion visit and again 12 months later, and also at 6 and 12 months thereafter (i.e. 0, 12, 18 and 24 months from inclusion).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention group</intervention_name>
    <description>Please see the preceding section</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI _&gt; 30 OR _25 With at least one Medical condition related to overweight&#xD;
             (hypertension, dyslipidemia, metabolic syndrome, diabetes mellitus II, hip- or knee&#xD;
             pain)&#xD;
&#xD;
          -  written consent&#xD;
&#xD;
          -  sufficient knowledge in Norwegian Language to acquire the written and oral information&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any ongoing cancer condition&#xD;
&#xD;
          -  any current medication impacting on weight&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jørund Straand, Prof., Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>June 21, 2021</last_update_submitted>
  <last_update_submitted_qc>June 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Erik L Werner</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>overweight, general practice</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data on all outcomes will be available to researchers on request</ipd_description>
  </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/NCT03000062
org study id: MDN01
nct id: NCT03000062
lead sponsor: 
has dmc: Yes
In this study the investigators want to explore the feasibility and effect of a simple
      intervention provided by primary care physicians on treatment for overweight in general
      practice. Regular patients visiting their ordinary family physician will be asked for
      participation if they comply with the inclusion criteria. If so, they will follow a detailed
      food list for 12 months with regular visits to the doctor. At each visit, the participating
      patients will be asked about their progress on weight loss and all measurements will be made.
      Simultaneously a control group of primary care physicians will also recruit patients that
      fulfill the inclusion criteria. These patients will also provide data that will serve as
      Control to the intervention group.
The number of patients with overweight is increasing and a daily issue in general practice.
      Many patients wish to discuss their weight problem with their family physician but many of
      these feel helpless to guide their patients in how to reduce weight. Providing useful and
      correct information should not be so difficult but many doctors choose to refer their
      patients to dietary courses or follow-up in specialist health care.In this study the
      investigators wish to implement a simple tool for treatment of overweight in primary care by
      providing the patients a detailed list for all meals that will ensure a weight loss. The
      patients will be given a close follow-up by their doctor, and the motivating conversation and
      list of meals will be the only treatment given.

      The study is a cluster randomised controlled trial where all general practices in the area of
      Moss city in Norway will be asked to participate. Half of the physicians will constitute the
      intervention group while the other half will serve as control group. Each participating
      doctor in both groups will recruit patients according to the eligibility criteria. The
      doctors in the intervention group will be provided with a course to learn the intervention
      and have a manual to follow for each patient. All participating patients of both groups will
      be asked to meet regularly for data collection.

      According to the power calculation, a number of 12 physicians in each group will be
      sufficient if they recruit 10 patients each.

      The intervention will be conducted for 12 months and thereafter data will be continued to be
      collected at 6 and 12 months after.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cluster randomized controlled trial
primary purpose: Treatment
masking: Single (Participant)
masking description: ID of participating patients are only available through the participating Family phyisican
measure: Weight reduction
time frame: 12 months
description: 10% weight reduction measured as kilo weight at inclusion
measure: Blood pressure
time frame: 12 months
description: Blood pressure measured as mean of three measurements at rest
measure: HbA1c
time frame: 12 months
description: Blood samples
measure: Waist measure
time frame: 12 months
description: Any reduction in cm of waist measure
measure: Total Cholesterol
time frame: 12 months
description: Blood samples
measure: Qualitative study
time frame: 24 months
description: Participating physicians and patients will be interviewed about their experiences With the intervention
arm group label: Intervention group
arm group type: Experimental
description: 12 Family physicians in primary care will constitute the Intervention group. They will enroll 10 patients each from their ordinary practice. The physicians will be provided with a specific course on the treatment model of the study, including how to collect and register data. They will have a detailed manual indicating the content of each visit.
Following recruitment and consent, the patient will meet for the first visit in the study one week later. At this visit the patient will be provided with detailed information on the content and preparation for all meals. Data will be collected.
The manual describes a diet in accordance with official guidelines providing the patient 1600Kcal per day.
The following visits will take place after 4 weeks, 8 weeks, 4 months, 8 months and 12 months from the first visit. Data will be collected at all visits, and also at 6 and 12 months follow-up.
arm group label: Control group
arm group type: No Intervention
description: 12 Family physicians in primary care will constitute the Control group. They will enroll 10 patients each from their ordinary practice. The physicians will not be provided with any information of the treatment model of the study but they will have all information about how to collect and register data.
The patients on this group will also sign consent to provide data and therefore they will know about the study but they do not get any specific information about weight loss other than the general information that their physician may tell them.
The patients in the Control Group will be asked to give data on inclusion visit and again 12 months later, and also at 6 and 12 months thereafter (i.e. 0, 12, 18 and 24 months from inclusion).
intervention type: Behavioral
intervention name: Intervention group
description: Please see the preceding section
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jørund Straand, Prof., Ph.D
role: Study Director
affiliation: University of Oslo
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Erik L Werner
investigator title: Professor
mesh term: Overweight
mesh term: Metabolic Diseases
sharing ipd: Undecided
ipd description: Data on all outcomes will be available to researchers on request