<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/NCT04439019</url>
  </required_header>
  <id_info>
    <org_study_id>REB19-1814</org_study_id>
    <nct_id>NCT04439019</nct_id>
  </id_info>
  <brief_title>Group Education &amp; Lifestyle Modification's Impact on Weight Loss &amp; Quality Life of Patients With OA</brief_title>
  <official_title>Group Education and Digitally Delivered Lifestyle Modification Program to Enable Weight Loss and Improve Metabolic Health and Quality of Life for Patients With Osteoarthritis and Overweight/Obesity.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alberta Hip and Knee Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Alberta Hip and Knee Clinic</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>
      Patients referred to Calgary's Alberta Hip &amp; Knee Clinic, while awaiting consultation with an&#xD;
      orthopedic surgeon for hip or knee osteoarthritis, will be offered the opportunity to&#xD;
      participate in a dietary counseling program with the goal of attaining weight loss prior to&#xD;
      surgery. Those patients interested in participating in the program will be offered the&#xD;
      opportunity to participate in the research trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity, osteoarthritis, and metabolic syndrome are interrelated diseases. In addition to&#xD;
      surgical management, there is the need to identify and provide earlier non-surgical&#xD;
      management for individuals with metabolic and body composition changes that are contributing&#xD;
      to osteoarthritis progression.&#xD;
&#xD;
      It has been well-established that is a challenge for clinicians to identify and deliver&#xD;
      optimal treatment approaches for patients with osteoarthritis and obesity. The long wait&#xD;
      times for orthopedic consultation in Alberta present an excellent opportunity to optimize&#xD;
      patients with medical comorbidities and can simultaneously improve the pain and disability&#xD;
      from their osteoarthritis. This is also an excellent opportunity to involve patients and&#xD;
      their families in co-managing their own disease and working towards better health and less&#xD;
      pain and disability.&#xD;
&#xD;
      The &quot;OA Optimization Program&quot; has been developed by Dr Berchuk, FRCPC, Diplomat of the&#xD;
      American Board of Obesity Medicine. It is a lifestyle and dietary modification program. In&#xD;
      cooperation with Calgary's Alberta Hip and Knee Clinic at Gulf Canada Square, Dr Berchuk will&#xD;
      offer patients this program while they await orthopedic consultation. This is an optional&#xD;
      program offered to all patients. There is an initial group information session for patients&#xD;
      who express interest. For those who choose to enroll, the program begins with a medical&#xD;
      assessment by Dr Berchuk. The initial consultation consists of a medical assessment which&#xD;
      includes medical history and physical examination, a previous dietary history, a readiness&#xD;
      for change assessment, and screening for contraindications to the program. The patients will&#xD;
      then attend group counselling sessions every 3 months for one year, or until their surgical&#xD;
      date. The group counselling will be supplemented by the Grohealth digital therapeutic&#xD;
      nutrition program. Participants return for group counselling sessions at Gulf Canada Square&#xD;
      clinic every 3 months until orthopedic consultation and if surgery is deemed appropriate,&#xD;
      until surgery.&#xD;
&#xD;
      As with any major lifestyle change, peer support is crucial to long term success. Patients&#xD;
      are encouraged to bring their family members to the initial consultation and to group&#xD;
      sessions. During the group sessions, Dr Berchuk will use techniques to encourage the building&#xD;
      of a peer support network, as well as medical cognitive behavior therapy techniques.&#xD;
&#xD;
      Investigators intend to demonstrate that the use of the OA Optimization program can lead to&#xD;
      improvement in Quality of Life measures including pain and disability in patients with severe&#xD;
      osteoarthritis, as well as improvements in markers of health such as BMI, waist&#xD;
      circumference, blood pressure, medication use in diabetic and hypertensive patients, and&#xD;
      markers such as serum lipids and markers of inflammation. It is entirely plausible that with&#xD;
      preoperative weight loss and/or improvement in metabolic disease, patients may see such&#xD;
      dramatic improvement in their symptoms that they choose to postpone surgery.&#xD;
&#xD;
      Research Question and Objectives:&#xD;
&#xD;
      Can the OA Optimization Program lead to improvement in pain and disability related to severe&#xD;
      osteoarthritis? Investigators aim to demonstrate that the use of a lifestyle and dietary&#xD;
      counselling program can lead to improvements in pain and disability in patients with severe&#xD;
      osteoarthritis.&#xD;
&#xD;
      Can the OA Optimization Program demonstrate significant improvements in obesity,&#xD;
      hypertension, hyperlipidemia, and glycemic control? Investigators aim to demonstrate&#xD;
      improvements in markers of health such as decreased BMI, decreased waist circumference,&#xD;
      decreased medication use in diabetic and hypertensive patients, improvement in biomarkers&#xD;
      such as serum lipids and serum markers of systemic inflammation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 1, 2021</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</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 &quot;OA Optimization Program&quot; is a lifestyle and dietary modification program. All Patients will be offered this optional program while they await orthopedic consultation. There is an initial group information session for participants followed by medical assessment which includes medical history and physical examination, a previous dietary history, a readiness for change assessment, and screening for contraindications to the program. The patients will then attend group counselling sessions every 3 months for 1 year, or until their surgical date Patients are encouraged to attend sessions with a family members. We intend to demonstrate improvement in Quality of Life measures including pain and disability in patients with severe osteoarthritis, as well as improvements in markers of health such as BMI, waist circumference, blood pressure, medication use in diabetic and hypertensive patients, and markers such as serum lipids and markers of inflammation.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BMI</measure>
    <time_frame>every 3 months over 12 months.</time_frame>
    <description>Change in BMI compared to last visit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>every 3 months over 12 months.</time_frame>
    <description>Change in blood pressure compared to last visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum lipids and markers of inflammation/ Glycemic acid</measure>
    <time_frame>every 3 months over 12 months.</time_frame>
    <description>Change in blood markers compared to last visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>every 3 months over 12 months.</time_frame>
    <description>Health-related quality of life as measured by EQ-5D-5L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain and functional limitation</measure>
    <time_frame>every 3 months over 12 months.</time_frame>
    <description>Pain and functional limitation as measured by WOMAC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication use</measure>
    <time_frame>every 3 months over 12 months.</time_frame>
    <description>Changes in use of diabetic and blood pressure medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>waist circumference</measure>
    <time_frame>every 3 months over 12 months.</time_frame>
    <description>Comparing waist circumference to last visit</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Obesity</condition>
  <condition>Osteo Arthritis Knee</condition>
  <condition>Osteoarthritis, Hip</condition>
  <arm_group>
    <arm_group_label>All patients referred to the Alberta Hip and Knee Clinic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients who are diagnosed with severe osteoarthritis undergoing total hip/knee replacement surgery and show interest to be part of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lifestyle and dietary modification program</intervention_name>
    <description>The &quot;OA Optimization Program&quot; is a lifestyle and dietary modification program. All Patients will be offered this optional program while they await orthopedic consultation. There is an initial group information session for participants followed by medical assessment which includes medical history and physical examination, a previous dietary history, a readiness for change assessment, and screening for contraindications to the program. The patients will then attend group counselling sessions every 3 months for 1 year, or until their surgical date.Patients are encouraged to attend sessions with a family member. Improvement in Quality of Life measures including pain and disability in patients with severe osteoarthritis, as well as improvements in markers of health such as BMI, waist circumference, blood pressure, medication use in diabetic and hypertensive patients, and markers such as serum lipids and markers of inflammation will be shown.</description>
    <arm_group_label>All patients referred to the Alberta Hip and Knee Clinic</arm_group_label>
    <other_name>Osteoarthritis(OA) Optimization program</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic osteoarthritis&#xD;
&#xD;
          -  BMI ≥ 25&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18&#xD;
&#xD;
          -  Currently following a specialized or therapeutic diet&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Type 1 Diabetes&#xD;
&#xD;
          -  Unable to read or speak English&#xD;
&#xD;
          -  Unwilling to use the digital application&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>February 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alberta Hip and Knee Clinic</investigator_affiliation>
    <investigator_full_name>Kelly Johnston</investigator_full_name>
    <investigator_title>Assistant Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>carbohydrate restriction</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>weight loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <!-- 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/NCT04439019
org study id: REB19-1814
nct id: NCT04439019
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients referred to Calgary's Alberta Hip & Knee Clinic, while awaiting consultation with an
      orthopedic surgeon for hip or knee osteoarthritis, will be offered the opportunity to
      participate in a dietary counseling program with the goal of attaining weight loss prior to
      surgery. Those patients interested in participating in the program will be offered the
      opportunity to participate in the research trial.
Obesity, osteoarthritis, and metabolic syndrome are interrelated diseases. In addition to
      surgical management, there is the need to identify and provide earlier non-surgical
      management for individuals with metabolic and body composition changes that are contributing
      to osteoarthritis progression.

      It has been well-established that is a challenge for clinicians to identify and deliver
      optimal treatment approaches for patients with osteoarthritis and obesity. The long wait
      times for orthopedic consultation in Alberta present an excellent opportunity to optimize
      patients with medical comorbidities and can simultaneously improve the pain and disability
      from their osteoarthritis. This is also an excellent opportunity to involve patients and
      their families in co-managing their own disease and working towards better health and less
      pain and disability.

      The "OA Optimization Program" has been developed by Dr Berchuk, FRCPC, Diplomat of the
      American Board of Obesity Medicine. It is a lifestyle and dietary modification program. In
      cooperation with Calgary's Alberta Hip and Knee Clinic at Gulf Canada Square, Dr Berchuk will
      offer patients this program while they await orthopedic consultation. This is an optional
      program offered to all patients. There is an initial group information session for patients
      who express interest. For those who choose to enroll, the program begins with a medical
      assessment by Dr Berchuk. The initial consultation consists of a medical assessment which
      includes medical history and physical examination, a previous dietary history, a readiness
      for change assessment, and screening for contraindications to the program. The patients will
      then attend group counselling sessions every 3 months for one year, or until their surgical
      date. The group counselling will be supplemented by the Grohealth digital therapeutic
      nutrition program. Participants return for group counselling sessions at Gulf Canada Square
      clinic every 3 months until orthopedic consultation and if surgery is deemed appropriate,
      until surgery.

      As with any major lifestyle change, peer support is crucial to long term success. Patients
      are encouraged to bring their family members to the initial consultation and to group
      sessions. During the group sessions, Dr Berchuk will use techniques to encourage the building
      of a peer support network, as well as medical cognitive behavior therapy techniques.

      Investigators intend to demonstrate that the use of the OA Optimization program can lead to
      improvement in Quality of Life measures including pain and disability in patients with severe
      osteoarthritis, as well as improvements in markers of health such as BMI, waist
      circumference, blood pressure, medication use in diabetic and hypertensive patients, and
      markers such as serum lipids and markers of inflammation. It is entirely plausible that with
      preoperative weight loss and/or improvement in metabolic disease, patients may see such
      dramatic improvement in their symptoms that they choose to postpone surgery.

      Research Question and Objectives:

      Can the OA Optimization Program lead to improvement in pain and disability related to severe
      osteoarthritis? Investigators aim to demonstrate that the use of a lifestyle and dietary
      counselling program can lead to improvements in pain and disability in patients with severe
      osteoarthritis.

      Can the OA Optimization Program demonstrate significant improvements in obesity,
      hypertension, hyperlipidemia, and glycemic control? Investigators aim to demonstrate
      improvements in markers of health such as decreased BMI, decreased waist circumference,
      decreased medication use in diabetic and hypertensive patients, improvement in biomarkers
      such as serum lipids and serum markers of systemic inflammation.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The "OA Optimization Program" is a lifestyle and dietary modification program. All Patients will be offered this optional program while they await orthopedic consultation. There is an initial group information session for participants followed by medical assessment which includes medical history and physical examination, a previous dietary history, a readiness for change assessment, and screening for contraindications to the program. The patients will then attend group counselling sessions every 3 months for 1 year, or until their surgical date Patients are encouraged to attend sessions with a family members. We intend to demonstrate improvement in Quality of Life measures including pain and disability in patients with severe osteoarthritis, as well as improvements in markers of health such as BMI, waist circumference, blood pressure, medication use in diabetic and hypertensive patients, and markers such as serum lipids and markers of inflammation.
primary purpose: Supportive Care
masking: None (Open Label)
measure: BMI
time frame: every 3 months over 12 months.
description: Change in BMI compared to last visit
measure: Blood pressure
time frame: every 3 months over 12 months.
description: Change in blood pressure compared to last visit
measure: serum lipids and markers of inflammation/ Glycemic acid
time frame: every 3 months over 12 months.
description: Change in blood markers compared to last visit
measure: Health-related quality of life
time frame: every 3 months over 12 months.
description: Health-related quality of life as measured by EQ-5D-5L
measure: Pain and functional limitation
time frame: every 3 months over 12 months.
description: Pain and functional limitation as measured by WOMAC
measure: Medication use
time frame: every 3 months over 12 months.
description: Changes in use of diabetic and blood pressure medication
measure: waist circumference
time frame: every 3 months over 12 months.
description: Comparing waist circumference to last visit
arm group label: All patients referred to the Alberta Hip and Knee Clinic
arm group type: Experimental
description: All patients who are diagnosed with severe osteoarthritis undergoing total hip/knee replacement surgery and show interest to be part of the study.
intervention type: Other
intervention name: Lifestyle and dietary modification program
description: The "OA Optimization Program" is a lifestyle and dietary modification program. All Patients will be offered this optional program while they await orthopedic consultation. There is an initial group information session for participants followed by medical assessment which includes medical history and physical examination, a previous dietary history, a readiness for change assessment, and screening for contraindications to the program. The patients will then attend group counselling sessions every 3 months for 1 year, or until their surgical date.Patients are encouraged to attend sessions with a family member. Improvement in Quality of Life measures including pain and disability in patients with severe osteoarthritis, as well as improvements in markers of health such as BMI, waist circumference, blood pressure, medication use in diabetic and hypertensive patients, and markers such as serum lipids and markers of inflammation will be shown.
arm group label: All patients referred to the Alberta Hip and Knee Clinic
other name: Osteoarthritis(OA) Optimization program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Alberta Hip and Knee Clinic
investigator full name: Kelly Johnston
investigator title: Assistant Clinical Professor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Hip
mesh term: Osteoarthritis, Knee
mesh term: Obesity
mesh term: Weight Loss