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Group Education & Lifestyle Modification's Impact on Weight Loss & Quality Life of Patients With OA

Primary Purpose

Obesity, Osteo Arthritis Knee, Osteoarthritis, Hip

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle and dietary modification program
Sponsored by
Alberta Hip and Knee Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring Obesity, carbohydrate restriction, Osteoarthritis, weight loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptomatic osteoarthritis
  • BMI ≥ 25

Exclusion Criteria:

  • Age < 18
  • Currently following a specialized or therapeutic diet
  • Pregnant or breastfeeding
  • Type 1 Diabetes
  • Unable to read or speak English
  • Unwilling to use the digital application

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    All patients referred to the Alberta Hip and Knee Clinic

    Arm Description

    All patients who are diagnosed with severe osteoarthritis undergoing total hip/knee replacement surgery and show interest to be part of the study.

    Outcomes

    Primary Outcome Measures

    BMI
    Change in BMI compared to last visit

    Secondary Outcome Measures

    Blood pressure
    Change in blood pressure compared to last visit
    serum lipids and markers of inflammation/ Glycemic acid
    Change in blood markers compared to last visit
    Health-related quality of life
    Health-related quality of life as measured by EQ-5D-5L
    Pain and functional limitation
    Pain and functional limitation as measured by WOMAC
    Medication use
    Changes in use of diabetic and blood pressure medication
    waist circumference
    Comparing waist circumference to last visit

    Full Information

    First Posted
    February 27, 2020
    Last Updated
    January 13, 2021
    Sponsor
    Alberta Hip and Knee Clinic
    Collaborators
    University of Calgary
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04439019
    Brief Title
    Group Education & Lifestyle Modification's Impact on Weight Loss & Quality Life of Patients With OA
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2021 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    October 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Alberta Hip and Knee Clinic
    Collaborators
    University of Calgary

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Osteo Arthritis Knee, Osteoarthritis, Hip
    Keywords
    Obesity, carbohydrate restriction, Osteoarthritis, weight loss

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    All patients referred to the Alberta Hip and Knee Clinic
    Arm Type
    Experimental
    Arm 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(s)
    Lifestyle and dietary modification program
    Other Intervention Name(s)
    Osteoarthritis(OA) Optimization program
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    BMI
    Description
    Change in BMI compared to last visit
    Time Frame
    every 3 months over 12 months.
    Secondary Outcome Measure Information:
    Title
    Blood pressure
    Description
    Change in blood pressure compared to last visit
    Time Frame
    every 3 months over 12 months.
    Title
    serum lipids and markers of inflammation/ Glycemic acid
    Description
    Change in blood markers compared to last visit
    Time Frame
    every 3 months over 12 months.
    Title
    Health-related quality of life
    Description
    Health-related quality of life as measured by EQ-5D-5L
    Time Frame
    every 3 months over 12 months.
    Title
    Pain and functional limitation
    Description
    Pain and functional limitation as measured by WOMAC
    Time Frame
    every 3 months over 12 months.
    Title
    Medication use
    Description
    Changes in use of diabetic and blood pressure medication
    Time Frame
    every 3 months over 12 months.
    Title
    waist circumference
    Description
    Comparing waist circumference to last visit
    Time Frame
    every 3 months over 12 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Symptomatic osteoarthritis BMI ≥ 25 Exclusion Criteria: Age < 18 Currently following a specialized or therapeutic diet Pregnant or breastfeeding Type 1 Diabetes Unable to read or speak English Unwilling to use the digital application

    12. IPD Sharing Statement

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